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Satellite Document Research and Studies Collection CVD Project evaluation: Baseline diabetes study Davao, Philippines 2010 Technical Resources Unit June 2011 Ds/ R E 01 Author Sophie Pilleron Deputy to technical advisor on diabetes, Lyon, Handicap International With contributions from: Ivy Boyose‐Nolasco New Project manager of CVD project, Davao, the Philippines Jenny Hernandez Former project manager of CVD project, Davao, the Philippines Pauline Guimet Technical advisor on disabling diseases, Lyon, France Kirsten L. Lentz Technical coordinator, Manila, the Philippines Edited by: Michael Guy, Knowledge Management Unit, Handicap International, Technical Resources Unit 14, avenue Berthelot 69361 Lyon Cedex 07 France Graphics: IC&K, Frédérick Dubouchet Maude Cucinotta Cover Picture: © Ivy Boyose‐Nolasco for Handicap International 1 ABSTRACT Objective: To gather baseline data for the CVD Project evaluation and specifically for indicators 5 and 6 of expected result 1. This study also concerned gathering information on the nature of diabetes and common practices in diabetes management and care, to improve project implementation strategy and data on promoting health care services in the community. Method: This study was the first part of a quasi‐experimental before‐after here‐there study conducted in 10 intervention barangays and 5 control barangays of Davao City. The study population consisted of people with diabetes aged 20 years and above who had visited the Barangay Health centers and had proof of a doctor’s diagnosis for diabetes mellitus or proof of a relative‐to‐diabetes medicine prescription. They were all resident of the studied barangays and stated they had no plans to move away from the research site in the 4 years following the survey. The selection of the respondents was based upon the masterlist created by Barangay Health Workers of the study zone. The participants were interviewed using a structured questionnaire in a public facility far away from the health facility, in order to minimize information bias. In addition, anthropometric measurements (weight, height, and waist circumference), blood pressure, as well as the percentage of haemoglobin A1c, were also collected in a standardized way by a trained team. All the data collection process was pretested. Results: 503 participants in the intervention group and 136 in the control group were analysed. The mean age was 57 for both groups. The majority of them were female. Participants in the control group were less likely to be a college graduate or postgraduate than the intervention group and had a significantly lower income and a lower proportion of individuals in the highest possession category. The control group HbA1c mean (8.5% ±0.17) was statistically higher than in the intervention group one (7.8% ±0.08 ‐ p=0.003). The proportion of people with controlled blood sugar (HbA1C<6.5%) was higher in the intervention group (28.2%) than in the control group (17.6% ‐ p=0.013). There is no statistical difference for other indicators. The table below presents the baseline values for monitoring indicators: Baseline values for monitoring indicators (%) Intervention area Control area p Diabetes control status Variables HbA1c<6.5% 28.23 17.65 0.013 <80 cm for women or <90 for men 20.76 25.00 0.29 BMI < 23 kg.m² 34.26 36.76 0.587 24.85 20.59 0.301 61.94 68.38 0.199 20.68 16.18 0.242 Anthropometry Blood pressure ≤130/80 mmHg Physical activity at least moderate physical activity Diabetes knowledge score≥5 Conclusion: Despite its limitations, this study provides a first insight on the people living with diabetes in Davao City. With 72% of diabetics having uncontrolled glycemia, this study shows the relevance of the CVD project. As a baseline, this study provides comparison elements for the 2013 survey in order to test effectiveness of the CVD project with the percentage of diabetics with HbA1c<6.5% as effectiveness criterion. 2 CONTENTS ABSTRACT.................................................................................................................................................................................2 CONTENTS ................................................................................................................................................................................3 LIST OF FIGURES.......................................................................................................................................................................5 ACKNOWLEDGEMENTS............................................................................................................................................................6 LIST OF ABBREVIATIONS..........................................................................................................................................................7 I – INTRODUCTION ...................................................................................................................................................................8 II – PROJECT BACKGROUND.....................................................................................................................................................8 III – JUSTIFICATION ................................................................................................................................................................10 IV – OBJECTIVES .....................................................................................................................................................................10 V – METHODS.........................................................................................................................................................................11 5.1 DESIGN OF THE STUDY ........................................................................................................................................................11 5.2 PROJECT SITE....................................................................................................................................................................11 5.3 STUDY SITE ......................................................................................................................................................................12 5.3.1‐ Intervention area ................................................................................................................................... 12 5.3.2‐ Control area .......................................................................................................................................... 13 5.4 ‐ TARGET POPULATION .......................................................................................................................................................13 5.5 SAMPLE SELECTION............................................................................................................................................................13 5.6 DATA COLLECTION .............................................................................................................................................................14 5.6.1‐ The questionnaire .................................................................................................................................. 14 5.6.2‐ Data‐collection process .......................................................................................................................... 14 VI – DATA MANAGEMENT .....................................................................................................................................................15 6.1 DATA ENTRY AND DATA CHECKS ...........................................................................................................................................15 6.2 CREATION VARIABLES .........................................................................................................................................................15 6.2.1‐ Glycosylated hemoglobin or HbA1c ......................................................................................................... 15 6.2.2‐ Anthropometric variables ....................................................................................................................... 16 6.2.3‐ Blood pressure ...................................................................................................................................... 16 6.2.4‐ Possession score.................................................................................................................................... 16 6.2.5‐ Knowledge score ................................................................................................................................... 17 6.2.6‐ Physical activity .................................................................................................................................... 17 6.2.7‐ Disability .............................................................................................................................................. 18 VII –ANALYSIS.........................................................................................................................................................................19 7.1 – ANALYSIS PLAN ..............................................................................................................................................................19 7.2 – ANALYSIS STRATEGY ........................................................................................................................................................19 VIII ‐ ETHICAL ASPECTS ..........................................................................................................................................................19 IX ‐ RESULTS ...........................................................................................................................................................................20 9.1‐ STUDY POPULATION DESCRIPTION .......................................................................................................................................20 9.1.1‐ Socio‐demography ................................................................................................................................ 20 9.1.2‐ Anthropometry, blood pressure and biological measures ........................................................................ 22 9.1.3‐ Physical activity level............................................................................................................................. 23 9.1.4‐ Diabetes and disability .......................................................................................................................... 23 9.2‐ MONITORING INDICATORS .................................................................................................................................................24 9.3‐ NATURE OF DIABETES .......................................................................................................................................................25 9.4‐ DIABETES MANAGEMENT AND CARE.....................................................................................................................................26 9.4.1‐ Routine check‐ups and medications........................................................................................................ 26 9.4.2‐ Nutritionist‐dietetician .......................................................................................................................... 27 9.4.3‐ Education session .................................................................................................................................. 28 9.4.4‐ Payment of diabetes care ...................................................................................................................... 29 9.5‐ KNOWLEDGE ABOUT HEALTH CARE SERVICES PROPOSED BY BARANGAY HEALTH CENTRE..................................................................30 3 9.6‐ MOST EFFECTIVE MEANS OF NOTIFICATION FOR UPCOMING EVENTS IN THE BARANGAY HEALTH CENTRE ............................................30 X‐ DISCUSSION .......................................................................................................................................................................32 X‐ DISCUSSION .......................................................................................................................................................................32 10.1‐ OBJECTIVES AND MAIN RESULTS .......................................................................................................................................32 10.2‐ LIMITATIONS ................................................................................................................................................................33 10.3‐ COMPARISONS WITH LITERATURE .....................................................................................................................................34 XI‐ CONCLUSION ....................................................................................................................................................................36 XII‐ SOME RECOMMENDATIONS FOR THE 2013 SURVEY .....................................................................................................36 XII‐ REFERENCES.....................................................................................................................................................................37 APPENDIX 1: THE QUESTIONNAIRE .......................................................................................................................................40 APPENDIX 2: BLOOD TESTING FOR HEMOGLOBIN A1C ........................................................................................................45 APPENDIX 3: OTHERS SYMPTOMS DECLARED BY PARTICIPANTS ........................................................................................47 APPENDIX 4: OTHER ANTI‐DIABETICS DRUG THAN THOSE PRELISTED ................................................................................49 APPENDIX 5: OTHER REASONS FOR NOT VISITING THE NUTRITIONIST ...............................................................................50 APPENDIX 6 : OTHER BARANGAY HEALTH CENTER SERVICES DECLARED BY RESPONDENTS..............................................50 APPENDIX 7: PHASE 1 LOGICAL FRAMEWORK: FURTHER DETAILS ......................................................................................51 4 LIST OF TABLES Table 1 ‐ Socio‐demographic characteristics.................................................................................................................21 Table 2 ‐ Anthropometric and biological measures (%).................................................................................................22 Table 3 ‐ Distribution of type of limitation of activities according to the degree of severity (%) ....................................24 Table 4 ‐ Baseline values for monitoring indicators (%) ................................................................................................24 Table 5 ‐ Diabetes history ............................................................................................................................................25 Table 6 ‐ Hypertension history and its management ....................................................................................................26 Table 7 ‐ Repartition of the participants according to the test performed at least once in the past 12 months (%) ........26 Table 8 ‐ Mean number of test in the previous 12 months (±se) ...................................................................................27 Table 9 ‐ Repartition of participants according to the anti‐diabetes medication declared (%) .......................................27 Table 10 – Health facility where the nutritionist was consulted (%‐n=195) ...................................................................28 Table 11 – Reasons for not having visited a nutritionist (%)..........................................................................................28 Table 13 ‐ Mean found to pay diabetes care (%)...........................................................................................................29 Table 14 ‐ Distribution of sample according to health services declared (%) .................................................................30 Table 15 ‐ Way of notification (%) ................................................................................................................................30 Table 16 – Other Ways of notification mentioned by respondents (%)..........................................................................31 Table 17 – Baseline and final expected values of monitoring indicators........................................................................32 Table 18 Other Symptoms (%) .....................................................................................................................................47 Table 19 Others complications (%)...............................................................................................................................47 Table 20 Other antihypertensive drugs (%) ..................................................................................................................48 Table 21 Other anti‐diabetic drugs (%).........................................................................................................................49 Table 22 Other reasons for not visiting the nutritionist (%) ..........................................................................................50 Table 23 Other services available at the Barangay health office (%) .............................................................................50 LIST OF FIGURES Figure 1 – Map of the Philippines............................................................................................................................... 11 Figure 2 – Location of Davao City ............................................................................................................................... 11 Figure 3 – Flow chart ................................................................................................................................................. 20 Figure 4 – Distribution of HbA1c rate among intervention group and control group (%).............................................. 22 Figure 5 – Distribution of the sample according level of physical activity (%) .............................................................. 23 Figure 6 – Origin of diabetes educators (%) ................................................................................................................ 29 5 ACKNOWLEDGEMENTS We would like to thank all the people who made this survey feasible. Specifically, many thanks to the Barangay Captains of the following barangays: Lapu‐Lapu, 23‐C, Maa, Toril, 5‐A, Mintal, Calinan, Pampanga, Matina Aplaya as well as Panacan, Ilang, Tibungco, Bunawan and Lasang. A special thanks to the Davao City Health Office and the Barangay health workers who listed patients with diabetes in their own barangay. This survey would not have been possible without the participants with diabetes who gave us their time to conduct this survey. 6 LIST OF ABBREVIATIONS BHW Barangay Health Worker BMI Body Mass Index CHO City ealth Office CVD project Capacity‐building Project for the Prevention of Disabilities Related to Cardiovascular Risks Project DCCT Diabetes Control and Complications Trial DJFRD Davao Jubilee Foundation for the Rehabilitation of the Disabled FBS Fasting blood sugar HbA1c Glycosylated Hemoglobin A1c IDF International Diabetes Federation IPAQ International Physical Activity Questionnaire MET Metabolic Equivalent of Task (or Metabolic Equivalent) Php Philippines Peso PWDM People with diabetes mellitus RHRDCXI Regional Health Research and Development Consortium XI Se Standard error SPMC Southern Philippines Medical Center T2DM Type‐2 Diabetes Mellitus WC Waist circumference WHO World Health Organization 7 I – INTRODUCTION With an estimated 285 million adults living with diabetes in 2010 and 439 million by 2030, diabetes is increasing across the world (1). The latest estimations state that 6.8% of all‐cause mortality is attributable to diabetes. Diabetes is therefore, without doubt, a serious public health problem (2). Diabetes is a chronic disease which, over time, causes serious damage to many of the body's systems, especially the nerves and blood vessels, often leading to limb amputation, blindness, kidney failure and other conditions (3). As reported by the International Diabetes Federation (IDF), every 30 seconds a lower limb is lost due to diabetes, whereas 85% of all diabetes‐related amputations are preceded by foot ulcers and therefore can be prevented (4). Almost 80% of diabetes deaths occur in low and middle‐income countries. Almost half of diabetes deaths occur in people under the age of 70 years; 55% of diabetes deaths are in women. The World Health Organization (WHO) projects that diabetes deaths will increase by more than 50% in the next 10 years without urgent action. Most notably, diabetes deaths are projected to increase by over 80% in upper‐middle income countries between 2006 and 2015. (3) Some projections show that by the year 2025, more than three‐quarters of all persons with diabetes will reside in developing countries. India and China are leading this surge with sub‐Saharan Africa currently following at a much lower prevalence rate. (5) According to the estimations of Shaw et al. for 2010, diabetes prevalence in the Philippines is 6.7% and will increase to 7.8% by 2030. In other words, 3.4 million of people are currently affected by diabetes and this will increase to 6.2 million by 2030. (6) The 2005 Philippines Health Statistics states that diabetes mellitus is the 8th leading cause of mortality in the Philippines and accounted for 18,441 deaths. Diabetes mellitus is the 8th cause of mortality among males with 8,912 deaths and a rate of 20.8/100.000 population while this is the 5th cause of mortality among females with 9,529 deaths and a rate of 22.5/100.000 population. (7). A cross‐sectional population‐based study was conducted in 2002 among 7044 adults aged 20‐65 years old residents of urban and rural areas in Luzon in the Philippines estimated the crude diabetes prevalence to 5.1% which represented a 54% increase over the figure (3.3%) in 1982. This study reported that diabetes was unknown by one in three diabetics (8). A cohort study conducted in 6 of the Philippines’ 13 regions in 2007 by Soria et al. stated that the 9‐year incidence of type 2 diabetes mellitus (T2DM) was 16.3% among Filipinos and the prevalences of diabetes and pre‐ diabetes were respectively 28% and 31.5%. (9) In Davao, according to the City Health of Office, over the period 2004‐2008, diabetes was ranked the 7th all‐age leading cause of mortality with 279 deaths on average annually or 20.6 per 100,000 inhabitants. In 2009, diabetes was the 7th all‐ age leading cause of mortality with 317 deaths or 22.2 per 100,000 inhabitants. II – PROJECT BACKGROUND The Capacity‐building Project for the Prevention of Disabilities related to Cardiovascular Risks (CVD project) aims to build local capacities to fight diabetes and resulting disabilities. It began as a three‐year initiative in ten barangays in Davao City with funding support from the Ministry of Foreign Affairs of Luxembourg and Sanofi Aventis. It is being implemented with a local inclusive development approach focusing on the autonomy of, and coordination between, local stakeholders, in order to achieve sustainability. Today, the project has expanded into a city‐wide cardiovascular risk‐ management approach for greater impact. Handicap International is implementing this project in partnership with the Davao City Health Office (CHO), Davao Jubilee Foundation for the Rehabilitation of the Disabled (DJFRD), Southern Philippines Medical Center (SPMC), Diabetes Support Groups and the Barangay Councils of the ten pioneer barangays. 8 The Pilot From 2007 to 2009 Handicap International assisted in decentralizing diabetes prevention, care and management by capacity–building of health centers through the City Health Office in the ten pioneer barangays. This project has also established a local comprehensive approach to diabetic foot care and management. Adapted prosthetic and orthotic technologies appropriate for persons with diabetes were made available through capacity‐building of Davao Jubilee Foundation. Finally, advocacy work resulted in improved financial and geographical access to medicines and blood sugar testing. The Second Phase Building on the know‐how gained from the pilot phase, the project will continue the decentralization of diabetes prevention, care and management to all of the 182 barangays in Davao City. This is made possible through the creation of a cardiovascular program of the city government. As a result of capacity‐building activities, it is expected that local stakeholders (health care providers, local government units, and persons at risk of cardiovascular diseases) by the end of the project are empowered to implement an integrated cardiovascular risk management approach (focusing on diabetes and hypertension) and to coordinate their actions to improve access to health care services. Expected results a. The competence and autonomy of the public primary health care of Davao are improved in the frame of the cardiovascular risk factor management (focus on diabetes and arterial hypertension) b. Organizations of persons with diabetes in Davao City are empowered to manage their group and sustain their activities c. The rehabilitation services at the public tertiary health care level have improved capacity to take care of persons disabled by cardiovascular diseases or diabetes d. Local health and rehabilitation stakeholders implement an effective referral system for persons living with cardiovascular risk factors Activities a. AWARENESS‐RAISING: The project produces educational tools and organizes events to increase public awareness b. CAPACITY‐BUILDING OF PRIMARY HEALTH CARE PROVIDERS: The project equips health centers with knowledge, skills and tools to enable them to provide services on diabetes and cardiovascular risk factors for increased geographic and financial access to health care c. CAPACITY‐BUILDING OF DIABETES SUPPORT GROUPS: Handicap International trains and facilitates people with diabetes to form self‐help groups. Through these groups, people with diabetes mellitus (PWDM) are able to share their experiences with other people and to learn and understand more about their disease. Once organized, the groups are empowered to manage their organization and sustain their activities d. SUPPORT TO LOCAL GOVERNMENT UNITS: Access to appropriate health care is a right not a privilege. The project works with local policy makers to mainstream the issue of diabetes and cardiovascular risk. Policies in support of diabetes and cardiovascular risk prevention and management can help. The poorest families who must make the choice between paying for medicines or food e. SUPPORT FOR INCREASED ACCESS TO DIABETIC FOOT CARE: Through the project, the skills of local prosthetic and orthotic technicians are upgraded to ensure appropriate technology is used. Handicap International also works with Davao Medical Center for diabetic foot problems f. REFERRAL SYSTEM: The project facilitates coordination among major stakeholders to ensure that efforts are harmonious and not duplicated 9 III – JUSTIFICATION Six indicators were defined to measure the achievement of the first expected result of the CVD project, among them: Indicator 5: In the 10 pilot Barangays, increase by 20% of the proportion of people with diabetes who: a. have an acceptable level of HBA1C (<6.5%) b. maintain an appropriate Body Mass Index (<23 kg/m²) and waist circumference c. have an acceptable blood pressure (<130/80) d. do physical activity at least 30 minutes 3 times a week Indicator 6: Increase by 50% of the people with diabetes mellitus in the ten pilot barangays whose diabetes knowledge test score reaches 60%. These two indicators above were measured by conducting a survey among people with diabetes visiting the Barangay health centers. IV – OBJECTIVES The primary objective of this study was to gather baseline data for two indicators of the expected results 1 of the CVD Project as part of project evaluation. Specifically, this study generated: 1. Data about the population with diabetes, specifically the: a. Percentage of people with good glycemic control b. Percentage of overweight people c. Percentage of people with abdominal obesity d. Percentage of people with acceptable blood pressure levels e. Percentage of people with physical activity of at least 30 minutes three times a week f. Percentage of people whose diabetes knowledge test scores reach 60% 2. Information on the nature of diabetes and common practices in diabetes management and care to improve project implementation strategy 3. Data on promoting health care services in the community 4. Disability and morbidity data to support advocacy and policy development 10 V – METHODS 5.1 Design of the study A cross‐sectional survey with control group was conducted between June and August 2010. 5.2 Project site Davao City is a sprawling metropolis of over one million people, located in the Southeastern part of Mindanao. In August 2007, the estimated population was 1,363,337. It is one of the largest cities in the world with a land area of 2,443.61 square kilometers. It is a place rich in natural resources. The soil is very fertile and rich in minerals. The city has an abundant source of potable water. Located in a typhoon‐free zone, its tropical weather is characterized by an even distribution of climatic elements all year round. The temperature ranges from 15 to 34˚C. On the west, the city’s boundary line cuts through the highest peak in the country, the inactive Mt. Apo at 3,142 meters above sea level. Figure 1 ‐ Map of The Philippines Figure 2 – Map of Davao City Copyright © 2008 Davao Guide 11 As 71 percent of the population resides in urban areas, its urban density is estimated roughly at 2,262 persons per square kilometer. In 2000, 34.8% of the population was less than 15 years old and 3.1% was aged 65 years old and above. In 2000, the life expectancy projected for 2000‐2005 was 68.2 years old for males and 72.5 years old for females. With a predominantly migrant population, the city is very culturally diverse. Major languages and dialects in the city are Filipino, Chinese, English and Cebuano. The city has one of the highest literacy rates in Asia at 98.3%. Like the rest of the country, Davao City operates on an economic system that is market‐oriented, although pricing mechanisms remain regulated in some sectors (particularly for basic commodities) to protect consumers. Davao City enjoys a diverse economy, featuring a sound mix between agricultural (roughly 45%), industrial (15%) and service (at around 35%) industries. Poverty reduction has become the main goal of the local government. This is being addressed through various programs and projects, one of which concerns the encouragement of inward investments to industries that are labor‐intensive. Fortunately for Davao, private investments have ensured steady growth of Davao City’s economy over the last two decades. Davao City is divided into 3 districts and 182 barangays. There are about 31 hospitals with a total of 1,963 beds in Davao City. Medical services are made available to poor residents through the Southern Philippines Medical Center (previously Davao Medical Center), which has the most number of hospitals beds at 1,200. (10) 5.3 Study site 5.3.1‐ Intervention area 1 The intervention area was the ten pilot barangays 2 of Davao City selected for the first phase of the project (2007‐ 2009). The selection of the pilot barangays was carried out by Handicap International in consultation with other organizations involved in the project: City Health Office, Davao Medical Center, Davao Jubilee Foundation and Davao Sugar Club. The selection criteria were as follows: 1. Barangay where each of the four main partners already works 2. Barangay where there are some identified patients with diabetes (by sugar groups) 3. Not too distant from each other 4. At most, one hour away from Davao Medical Center 5. Davao City proper 6. Tenable peace and order 7. Existing health centre within the barangay 8. High number of indigents; random sampling across socio‐economic brackets. The ten pilot barangays were Toril, 23‐C, Maa, Lapu‐Lapu, 5‐A, Mintal, Calinan, Talomo proper, Pampanga, Matina Aplaya. However, Talomo Proper was not included in the current study because of the non‐participation of its leaders in the phase 1 project activities. 1 Intervention refers to the capacity-building of the City Health Office health care teams in these barangays through training and provision of tools and equipment. It is then the health care teams who will apply their know-how in their barangay through provision of cardiovascular risk care services. Barangay is the smallest administrative division in the Philippines and is the native Filipino term for a village, district or ward (source: wikipedia) 2 12 5.3.2‐ Control area The phase 2 project plans to be implemented in the entire Davao City from 2010 to 2013. Five barangays in Davao, where the intervention of the project will begin in 2013, were selected as a control group. It is assumed that the project will have little or no impact in the control area prior to the after‐study. In a consultative meeting between Handicap International and the City Health Office on 27th May 2009, the District Health Officers of Davao City voted for Bunawan as the control District. This was because the District health officer of Bunawan had not attended any of the trainings provided by Handicap International during the first phase of the diabetes project. The District Health Officer of Bunawan was asked to choose five out of eight from the barangays in her District. She chose the biggest barangays along the main road. It was assumed that it would be difficult to reach a good sample size in the three other Barangays. As a result, Panacan, Ilang, Tibungco, Bunawan and Lasang were the five control barangays. 5.4 ‐ Target population The study population consisted of the people with diabetes who visited the Barangay Health centers and who presented the following criteria: Inclusion criteria Aged 20 years and above Diagnosed by a doctor for diabetes mellitus and presented a proof of diagnosis or relative‐to‐diabetes medicine prescription Resident of one of the ten pilot Barangays for the intervention group or one of the five control Barangays for the control group Have no plans to move out of the research site during the 4 years following the survey (the duration of the phase 2 of the CVD project) Exclusion criteria Patients who were confined to a bed, on renal dialysis; patients with category 3 diabetic foot and post stroke; patients who were paraplegic, hemiplegic, and aphasic or with thinking and memory problems were excluded in order to minimize drop‐out rate. Patients who were confined to a bed were also excluded because it is difficult to measure height, weight and waist circumference. Pregnant women were also excluded since the anthropometric measures would be biased due to pregnancy. 5.5 Sample selection The available funds allowed for an exhaustive recruitment of all people with diabetes listed by Barangay health workers (BHWs). BHWs listed a total of 1,457 people with diabetes: 1,078 and 379 respectively in the intervention group and the control group. During the survey, 50 people were identified as not actually diabetic. Thus, it was decided to include walk‐in participants who met the inclusion criteria for replacement, but limited to the number of HbA1c tests available. 13 5.6 Data collection 5.6.1‐ The questionnaire The questionnaire was divided into 5 sections: Section 1 dealt with history of diabetes and hypertension as complication Section 2 gathered more information about hypertension and patient health‐seeking behavior. Questions 16 and 17 were used to plan the strategy on health care services promotion Section 3 consisted of a short set of questions on disability developed by the Washington Group on disability statistics (11) that were added to develop the beneficiaries with disability database in Handicap International Section 4 questions were generated based on the IDF Diabetes Education Standards (12) and allowed the creation of a knowledge score Section 5 corresponded to the self‐administered short version of the International Physical Activity Questionnaire (IPAQ) (13), which was used to measure the physical activity level of people with diabetes Information on birth date, gender, education level, occupation, income level and asset ownership were also obtained by questionnaire A specific part was dedicated to the anthropometric (height, weight, waist circumference) and biological (blood pressure and HbA1c test results) values measured along with the interview on the first page of the questionnaire The questionnaire was initially prepared in English and then translated by the research team to enable face‐to‐face interviews in the Visayan language. The English version of the questionnaire is presented in Appendix 1. 5.6.2‐ Data‐collection process After updating (intervention area) or creating (control area) diabetes patient registry with BHWs, permission from the Barangay Captains was requested to conduct the survey, to use an indoor public facility and to contact target participants. The main criterion for the choice of the venue was that it should be far enough from the Health Center to avoid information bias. Health centers provide a lot of information on diabetes with posters or leaflets. The target respondents were contacted through purok 3 leaders and BHWs to explain the goal of the survey, encourage participation, present the schedule, ask for an appointment and give the consent form. Handicap International CVD Project Team recruited additional field interviewers. All field interviewers received a 1‐day training which included lecture and practice measurements. The survey was pretested in Barangay Sasa which did not belong to study area, utilizing the same conditions and methods as the actual survey. The definitive questionnaire was then finalized and printed. The data collection schedule was subject to the preference of the Barangay Council or the District Health Center and to the availability of the facilities. The number of days allocated to each barangay was decided based on the number of persons with diabetes identified in the master list. Upon arrival at the survey venue, the respondent presented the invitation letter together with an ID card. The participant’s name and age was verified, with corrections made to the list of selected participants as required. After giving their informed consent, the respondent’s name, gender, date of birth, address and contact number were entered in the registration sheet and one set of questionnaires was given to the respondent. When the participants were not listed in the master list, evidence of diagnosis was required in the form of medical certificate, doctor referral or laboratory test results. Then the participant proceeded to the interview. Once the interview was completed, the respondent remained seated while their blood pressure was measured and recorded in the questionnaire. Anthropometric measurements were then performed. Finally, the respondent proceeded to the blood testing area to test HbA1c. HbA1c was measured with capillary blood from a finger prick at the venue by a trained medical technologist. The blood was then analyzed by a 3 Purok is an administrative subdivision of a barangay 14 portative device using a fully automated boronate assay by spectrophotometry. The result was released five minutes later. The detailed procedure and the machine are described in appendix 2. The quality control assistant then performed a quality check on the questionnaire. Quality control measures during the survey involved checking and re‐calibrating equipment, monitoring the performance of the measurers and checking the completeness and quality of data. If the questionnaire was not complete or if there was a doubt on some data, the respondent was referred back to the concerned interviewer or measurer. “Passed” was stamped on the questionnaire’s first page once quality control criteria were satisfied. The HbA1c result form with interpretation and recommendation was immediately released to the respondent. The respondent then proceeded to the education area for short nutritional sessions and snacks were provided. VI – DATA MANAGEMENT 6.1 Data entry and data checks Version 3.1 Epidata software (14) was used for creating the data structure (including automated data checking controls) and entering data. Two trained data‐entry agents inputted data from the questionnaires (double data‐entry) at the Handicap International office. The two databases were then compared (to detect data‐entry mistakes), corrected and cleaned using logical checks. 6.2 Creation variables Some variables were categorized into several groups according to international recommendations, or literature, or variable distribution in the sample. Others were associated to create score. 6.2.1‐ Glycosylated hemoglobin or HbA1c HbA1c reflects mean glycemia of a person during the three past months and it is recommended for the glycemic control monitoring among patients with diabetes, to estimate the risk of complications, to judge the effectiveness of control measures taken and to adjust the treatment. The CVD project relies on the global guideline for type 2 diabetes of the IDF (15). This guideline recommends an HbA1c target level of less than 6.5%, “if easily achieved. This is taken as translating to basal self‐monitored plasma glucose level monitored plasma glucose levels <6.0 mmol/l (<110 mg/dl), with post‐prandial target levels of <8.0 mmol/l (<145 mg/dl).” This threshold, based on microvascular and macrovascular complications, was thus chosen for this study. The HbA1c machine could not provide exact measure for HbA1c above 14%. If the participant HbA1c rate was higher than 14%, 14% this was reported with a comment in the questionnaire. 15 6.2.2‐ Anthropometric variables Body mass index (BMI) BMI is calculated by dividing weight in kilograms by height in meters squared and rounded to 1 decimal place (kg/m²). Generally, high BMI is correlated with high all‐causes mortality risk, especially mortality linked to cardiovascular disease, cancers, diabetes and accidents. (16) Weight and height were measured at the venue. The weight was measured three times with participants wearing a pre‐ weighed gown. The participant weight was calculated by subtracting the gown weight. If the participants did not accept to wear a gown, she/he was weighed with her/his clothes and the weight was then reduced by 1.5 kg. The weight measured in this way was also used in the analysis. Overweight was defined for Asiatic people as BMI ranged between 23‐25 kg/m² and obesity as BMI value equals to or above 25kg/m². Normal BMI range is 18.5‐22.9 kg/m², below which is defined underweight. (17) Waist circumference (WC) is a measurement of central body‐fat, which is associated with insulin resistance, an indicator that affects blood sugar control. Contrary to BMI, WC takes into account body fat distribution. WC was measured inside a dressing room with all clothing removed excepted undergarments. The thresholds for Asiatic people were used, meaning 80 cm for females and 90 cm for males. (18) 6.2.3‐ Blood pressure Blood pressure was measured twice on both arms using a digital blood pressure monitor. A third measurement was taken in case of a 5‐mmHg difference between the two first measurements. The average was calculated for each arm and the higher one was used in the analysis. A detachable cuff of the digital blood pressure monitor was used in this study. It could accommodate up to a 43 cm diameter arm. If a participant’s arm was more than 43 cm in diameter blood pressure was not taken and the reason noted in the questionnaire. As recommended by both of WHO (19) and IDF (17), the blood pressure target is 130/80 mmHg for patients with diabetes. However, we defined two different variables to describe the study population. Hypertension was defined as diastolic pressure of 140 mmHg or higher or systolic pressure of 90 mmHg or higher or participants who declared taking anti‐hypertensive medications. Hypertension uncontrolled was defined as diastolic blood pressure of 130 mmHg or higher and a systolic blood pressure of 80 mmHg or higher with anti‐hypertensive medications. 6.2.4‐ Possession score A possession score was computed using 6 variables: ‐ ownership of refrigerator ‐ ownership of computer ‐ ownership of television ‐ ownership of vehicle ‐ ownership of washing machine ‐ ownership of air conditioner One point was dedicated to a positive answer and the sum was then calculated. Score range is 0‐6, with 0 for the lowest possession level and 6 for the highest one. 16 The score was then categorized into 3 groups: low, middle and high possession level. Thresholds were decided in the view of percentiles in the following way: ‐ low: score is below 2; ‐ middle: score is 2 or 3 ‐ high: score is above 3. 6.2.5‐ Knowledge score A knowledge score was calculated from section 4 questions. Only one right answer per question is possible. One point was allocated at each right answer. The sum of points was calculated. The range score is 0‐7. It is expected a 50%‐increase of participants with 60% of good answer by the end of the CVD project. As 60% of 7 equals to 4.2, it was decided to use 5 as threshold. 6.2.6‐ Physical activity The daily physical activity (PA) is very difficult to measure because of multiple aspects of physical activity. 30‐minute moderate physical activity is internationally recommended at least five times a week to prevent non‐communicable diseases,including diabetes. International physical activity questionnaire (IPAQ) assesses physical activity undertaken across a comprehensive set of domains, including: ‐ leisure time physical activity ‐ domestic and gardening (yard) activities ‐ work‐related physical activity ‐ transport‐related physical activity The short form of IPAQ is a 7‐item measure of four domains of activity: ‐ vigorous‐intensity PA (defined as activities that make you breathe much harder than normal) ‐ moderate‐intensity PA (defined as activities that make you breathe somewhat harder than normal) ‐ walking ‐ and sitting For each activity domain, examples are provided to indicate that activities of work, leisure‐time, house and garden work, and transportation are to be reported. Frequency (during the last 7 days) and duration (minutes/hours usually spent on one of those days) of vigorous intensity PA,, moderate‐intensity PA, and walking are to be reported as well. Only sessions of activity lasting at least 10 minutes are to be reported. The total time that they spend sitting on a week day, during the last 7 days is also to be reported. Computation of the total score for the short form requires summation of the duration (in minutes) and frequency (days) of walking, moderate‐intensity and vigorous‐intensity activities. Domain specific estimates cannot be estimated. IPAQ proposes to classify population into three levels of physical activity: low, moderate and high. For more information about IPAQ and score creation please visit the following website: http://www.ipaq.ki.se/ipaq.htm. Regarding the current survey, the indicator for project monitoring is 30‐minutes physical activity three times a week. We chose as proxy the moderate category of IPAQ classifications which is considered as equivalent to “half an hour of at least moderate‐intensity physical activity on most days, leisure‐time based physical activity population health recommendation.” The analysis of physical activity was limited to participants who were 69 years old or below since IPAQ is not recommended above this age group. 17 6.2.7‐ Disability Handicap International requires the provision of statistics on persons with disabilities who are beneficiaries of the project. Indeed it was interesting to include a disability indicator in this survey. It was important for this indicator to be easily measured and also conducive to comparisons with other Handicap International projects. According to the Convention on the Rights of Persons with disabilities, “disability is an evolving concept and that disability results from the interaction between persons with impairments and attitudinal and environmental barriers that hinders their full and effective participation in society on an equal basis with others” and “persons with disabilities include those who have long‐term physical, mental, intellectual or sensory impairments which in interaction with various barriers may hinder their full and effective participation in society on an equal basis with others.”. To date, there is not statistical/epidemiological tool developed to measure disability as defined by the Convention. However the Washington Group on Disability Statistics (WG) developed a set of six questions to measure limitations of activities in the sense of the International Classification of Functioning, Disability and Health (ICF) promoted by the World Health Organization (WHO). “The WG was formed as a result of the United Nations International Seminar on Measurement of Disability that took place in New York in June 2001. An outcome of that meeting was the recognition that statistical and methodological work was needed at an international level in order to facilitate the comparison of data on disability cross‐nationally.” The framework utilized for the development of the measure tool is the ICF model. “The ICF is WHO's framework for measuring health and disability at both individual and population levels.” It is a classification of health and health‐related domains. These domains are classified from body, individual and societal perspectives by means of two lists: a list of body functions and structure, and a list of domains of activity and participation. Since an individual’s functioning and disability occurs in a context, the ICF also includes a list of environmental factors. These questions are the ones in section 3 of the questionnaire in appendix 1. For the full text of the Convention on the Rights of Persons with disabilities, please visit http://www.un.org/disabilities/convention/conventionfull.shtml. For more information about the Washington Group on Disability Statistics, please visit the following website: http://www.cdc.gov/nchs/citygroup.htm. For more information about the ICF, please visit http://www.who.int/classifications/icf/en/. From these 6 questions, a disability score can be computed by adding the value of each item. The score range is 0‐18. An individual was considered as having functional limitation if the score was ≥2, meaning the individual answered at least one of the 6 questions with ‘with a lot of difficulty’ or at least two questions with “some difficulties”. (20) 18 VII –ANALYSIS 7.1 – Analysis plan The main objective of the current study is to obtain baseline values for indicators 5 and 6 of expected result 1 of the CVD project. A control group, from an area where the project was not implemented, was created to be able to measure the effectiveness of the CVD project. This study will be repeated at the end of the project in 2013. If a change of proportion of persons with diabetes with HbA1c <6.5% is observed at the end of the project in 2013 and not in the control group, it will provide evidence to confirm the effectiveness of the CVD project. Otherwise, if there is a similar change in both groups, we cannot conclude to the effectiveness of the project. Thus, the data analysis is mainly descriptive, comparing the intervention group with the control group. 7.2 – Analysis strategy The analysis strategy comprised a description of each variable, then, comparisons between control and intervention groups. The mean of continue quantitative variables are presented with its standard error (se). Percentages were not presented with their 95% confidence interval since the sample is not representative of the population with diabetes of the study area. Regarding comparisons, chi‐square test and Fisher exact test were used for categorized quantitative variables when appropriate. Logistic regressions were performed if appropriate. T‐test was used for continue quantitative variables after checking of the equality of variances. A level significance of 5% was used for each statistical test. VIII ‐ ETHICAL ASPECTS The study protocol was approved by the Regional Health Research and Development Consortium XI (RHRDC XI) for ethical review before conducting the survey. The CVD project team requested permission from the Barangay Captains to conduct the survey, to use their public facilities, and to contact the target respondents through purok leaders and Barangay Health Workers. Each participant signed an informed consent form in the local language. Blood pressure and HbA1c value were released to the participants for their records. The medical doctor present at the survey venue oriented participants toward a medical doctor if needed. Invited participants who did not meet inclusion criteria were measured for hypertension and invited to take a snack. 19 IX ‐ RESULTS Figure 3 presents the flow chart detailing the process to reach the sample size. 1,457 patients with diabetes were registered on the master list by the BHWs: 1,078 in the intervention area and 379 in the control area. 549 people listed came to the venue. Among them, 50 were not actual diabetics. 142 people with diabetes who came to the venue without invitation were included. A total of 641 people with diabetes were interviewed, measured and tested for HbA1c. Among them, 504 came from the intervention area while 137 came from the control area. Out of 641 respondents, two participants were excluded since they were less than 20 years old. Figure 3 ‐ Flow chart 1 457 listed - 1 078 in intervention area (IA) - 379 in control area (CA) 549 624 came to the did not come survey venue 499 50 142 diabetics were not actual diabetics not listed but were included 2 excluded 639 analysed (<20 y.o) 503 in IA 136 in CA The analysis was thus carried out on 639 participants: 503 in the intervention group and 136 in the control group. 9.1‐ Study population description 9.1.1‐ Socio‐demography Table 1 presents the detailed socio‐demographic characteristics of the intervention group and the control group. In the intervention group the mean age was 56.9 years old and the large majority of participants were women. The majority of respondents were homemakers (41.2%), of which 83.7% were women. 38.4% of participants declared that they worked, with around half was working part‐time. 76.7% participants attained at least high school level and 21.7% was graduated from College or even postgraduated. The mean income was 8.756 Php 4. 4 1 dollar ≈ 43.7 Philippines Peso (PhP) and 1 euro = 57.70 PhP. 20 The control group was different from the intervention group in education, income and possession score. The control group attained a significantly lower level of education than the intervention group (p=0.009). More specifically, the control group were less likely to be a college graduate or postgraduate even after adjustment for age and gender (p=0.009). Another important difference concerns income. Mostly, the control group was poorer than the intervention group. The control group had a significantly lower income and a lower proportion of individuals in the highest possession category. The income difference was still significant after adjustment for age and gender (p<0.001). Table 1 ‐ Socio‐demographic characteristics Variables Intervention area Control area p 56.94 (± 0.46) 57.09 (±0.86) 0.88 23.46 34.79 30.02 11.73 69.18 19.85 38.24 27.94 13.97 70.59 0.667 18.89 19.48 41.15 16.90 3.58 16.18 26.47 41.18 13.97 2.21 Elementary level 9.15 13.24 Elementary graduate 14.12 16.91 High School level 14.12 21.32 0.009 High school graduate 21.07 21.32 College level/vocational 19.88 18.38 College graduate/postgraduate 21.67 8.82 8,576.34 (±390.64) 5,891.91 (±666.88) 0.0006 Demography Mean Age (±se) Age (%) 20‐49 50‐59 60‐69 70 and above Women (%) Employment status (%) Working full‐time Working part‐time Homemaker Retired/pensioner Others1,* Educational attainment (%) Economy Income (±se) Possession score (%) 0.75 0.438* Low 21.07 26.47 Middle 42.54 55.88 <0.001 High 36.38 17.65 * Fisher exact test 1 “Others” category includes Unemployed or laid off and looking for a job; Unemployed or laid off and not looking for a job; and other category 21 9.1.2‐ Anthropometry, blood pressure and biological measures Table 2 gives results with regard to anthropometry, blood pressure and HbA1c level. In the intervention group, mean BMI was 24.6(±3.6) kg/m². One person out of five (22.3%) was overweight while two people out of five (43.4%) were obese. Mean waist circumference was 91.9 (± 9.2) cm among males and 89.7 (± 9.4) cm among females. 57% of participants were hypertensive and for 29.4% of those under medication the hypertension was not controlled. There was not a statistical difference either for the mean BMI between the intervention and the control groups or for hypertension proportion. Table 2 ‐ Anthropometric and biological measures (%) Variables Intervention area Control area p Underweight (<18.5 kg.m²) 2.99 8.09 Normal (≥18.5 and < 23 kg.m²) 31.27 28.68 Overweight (≥23 and < 25 kg.m²) 22.31 27.21 Obese(≥25 kg.m²) 43.43 36.03 57.06 29.42 61.03 27.94 0.405 0.736 BMI Blood pressure Hypertensive Hypertensive not controlled 0.023 0 0 2 5 Percent of participants 4 6 8 Percent of participants 10 15 10 20 The figure 4 presents the distribution of HbA1c in the intervention group and the control group. In the intervention group, the mode was 7.4%. The HbA1c median (value separating the higher half of a sample from the lower half) was 7.4% and 50% of the sample had HbA1c value comprised between 6.3% and 8.9%. The HbA1c mean was 7.8% with a standard error of 0.08. In the control group the mode was 8.4%, the median was 8.4% and 50% of the sample was comprised between 6.8% and 10.1%. The HbA1c mean was 8.5% with a standard error of 0.17. The control group HbA1c mean is statistically higher than in the intervention group one (p=0.003). Figure 4 ‐ Distribution of HbA1c rate (%) among the intervention group among the control group 4.0 6.0 8.0 10.0 HbA1c rate (%) 12.0 14.0 4.0 6.0 8.0 hba1c 10.0 12.0 22 14.0 9.1.3‐ Physical activity level Figure 5 shows the repartition of our sample according to levels of physical activity as defined by IPAQ. The majority of survey participants were categorized into the moderate‐level class, regardless of the group. Globally there was no significant difference between the intervention group and the control ones (p=0.078). Figure 5 – Distribution of the sample according to levels of physical activity (%) 50 45 40 Intervention area 45,73 Control area 41,18 38,97 35,29 35 30 23,53 25 20 15,31 15 10 5 0 Low Moderate High Regardless of control or intervention group, the median sitting time per week day was 120 minutes, or 2 hours. 25% of the sample declared to sit less than 60 minutes a week day in average during the 7 previous day and 25% more than 240 minutes a week day. 9.1.4‐ Diabetes and disability In the intervention group, 86.4% of participants were identified as having limitations of activities, most commonly regarding eyesight (84.3%), memory (75.4%) and walking (61.0%). Table 3 presents the repartition of participants according to the limitation of activities and its level for each group. The only significant difference observed between intervention and control group concerned difficulty with memory. A greater number of patients with diabetes in the control group declared they had “a lot of difficulties” with remembering or “cannot at all” as compared to the intervention group, even though they were less likely to declare having this difficulty (66.9% versus 75.3%). Even though the control group seemed to be more affected by more severe visual difficulties than the intervention group, the difference was not statistically significant. 23 Table 3 ‐ Distribution of type of limitation of activities according to the degree of severity (%) Intervention area Control area 0 1 2 or 3 0 1 2 or 3 P Difficulty seeing 15.71 74.16 10.14 13.97 69.12 17.91 0.090 Difficulty hearing 59.56 37.85 2.59 58.82 38.24 2.94 0.928* Difficulty walking or climbing 38.97 47.71 13.32 33.82 52.21 13.97 0.542 24.65 59.64 15.71 33.09 47.06 19.85 0.031 Difficulty with self‐care 86.68 11.93 1.39 80.15 17.65 2.21 0.131* Difficulty communicating 82.50 16.90 0.60 83.09 16.91 0.00 1.00* Difficulty remembering or concentrating 0: No difficulty; 1: Some difficulties; 2: lot of difficulties; 3: Cannot at all * Fisher exact test The proportion of people with low limb amputation was very low in both of the two groups. Eight (1.6%) and four participants (2.9%) respectively from intervention area and control area were amputated. The difference was not statistically significant (p=0.295 5). 9.2‐ Monitoring indicators The table 4 reports the baseline values for CVD project monitoring indicators in the intervention and the control group. The results illustrate the statistical significant difference in proportion of participants achieving HbA1c<6.5% between the two groups. The proportion of people with controlled blood sugar was higher in the intervention group than in the control group (p=0.013). This difference was maintained when age, gender, BMI, education attainment and income were taken into account (p=0.009). There was no significant difference for other indicators according to the group. Table 4 ‐ Baseline values for monitoring indicators (%) Variables Intervention area Control area p Diabetes control status HbA1c<6.5% 28.23 17.65 0.013 <80 cm for women or <90 for men 20.76 25.00 0.29 BMI < 23 kg.m² 34.26 36.76 0.587 24.85 20.59 0.301 61.94 68.38 0.199 20.68 16.18 0.242 Anthropometry Blood pressure ≤130/80 mmHg Physical activity at least moderate physical activity Diabetes knowledge score≥5 5 Fisher exact test 24 9.3‐ Nature of diabetes Table 5 gives some information about the diabetes history of participants. There was no statistical difference between intervention group and control group for all variables presented, except for “I do not remember”. Participants were mostly diagnosed with diabetes at 50 years old and on average 6 years had been elapsed since diagnosis. The three most frequently declared symptoms were (1) frequent urination, (2) fatigue and (3) extreme thirst. A high percentage of participants in both groups gave other symptoms than the ones prelisted. The most cited in both groups was dizziness since it was declared by more than 20%. Then we found limb numbness, itchiness, weakness, fever or sweating, etc. The detailed answers for both groups are available in appendix 3. Hypertension was the most common complication declared by participants in both groups, around 50%. Retinopathy follows with 22% of participants declared this in both of the groups. Some participants declared complications other than those prelisted. The most cited was problem linked to lungs (1.6% in intervention group and 2.2% in control group). Refer to appendix 3 for additional information. Table 5 ‐ Diabetes history Variables Intervention area Control area p Mean duration since diagnosis (±se) 5.79 (±0.26) 6.42 (±0.50) 0.2628 Mean age at diagnosis (±se) 50.65 (±0.49) 50.17 (±0.86) 0.6451 Diabetes Ŧ Symptoms (%) 34.79 32.80 14.51 13.32 34.00 28.03 30.75 48.51 3.78 37.50 32.35 13.24 7.35 38.97 33.09 27.08 57.35 0.00 0.558 0.921 0.705 0.058 0.281 0.249 0.488 0.067 0.019* Neuropathy 6.40 6.62 0.927 Retinopathy Nephropathy Hypertension Heart disease Erectile dysfunction2 (n=194) Vaginal itchiness1 (n=442) Others complications None I do not know 22.20 8.60 51.59 11.60 3.90 10.98 6.60 32.00 2.80 22.06 6.62 47.06 12.50 0.00 11.46 5.15 34.56 2.21 0.972 0.454 0.348 0.773 0.349* 0.896 0.536 0.572 1.000* Frequent urination Extreme thirst Extreme hunger Sudden lost of weight Fatigue On and off blurring of vision Vaginal itches1 (n=444) Others symptoms I do not remember Complications Ŧ (%) 1 2 3 % computed only for women; % computed only for men; several answers were possible that is why sum of percentage by group is more than 100%. Ŧ This answers were given by respondents themselves without medical proof. * Fisher exact test Table 6 presents some variables linked to hypertension history and its management. On average, hypertension was diagnosed at 50 years old, regardless of the group. The large majority of participants were on anti‐hypertensive medication. Among those, one third were under Metoprolol and around 9% under Captopril. More than 60% in both groups cited other antihypertensive drugs than those prelisted. The three most drugs cited were 25 Amlodipine (9.5% in intervention group and 5.2 in control group), Losartan (around 8% in both of two groups) and Nifedipine (3.4% in intervention group and 5.9% in control group). Other drugs cited are showed in appendix 3. Table 6 ‐ Hypertension history and its management Variable Intervention area Hypertension Mean age at diagnosis (±se) Anti‐hypertensive medication (%) Anti‐hypertensive medication (%) Metoprolol Captopril Others I don’t know Control area p 50.82 (±0.79) 91.89 49.55 (±1.77) 89.06 0.484 0.471 33.75 8.40 62.14 7.05 33.33 8.77 61.02 11.86 0.952 0.928 0.873 0.222 9.4‐ Diabetes management and care 9.4.1‐ Routine check‐ups and medications Table 7 below describes diabetes management and care. In the intervention group, 9.3% of participants declared having no check‐up in the previous 12 months. However the majority declared at least 4 check‐ups. There was no statistical difference with the control group. For each listed examination, the proportion of participants who performed at least one examination was always higher in the intervention group than in the control group. However the difference was only statistically significant for HbA1c, cholesterol tests and fasting blood sugar done in lab. All these differences were still significant after adjustment for gender, age, income and glycemia control status. Table 7 ‐ Repartition of the participants according to the test performed at least once in the past 12 months (%) Variables Intervention area Control area p Fasting Blood Sugar (FBS) using Glucometer FBS done in lab HbA1c test Blood pressure measure Cholesterol or lipid profile done Foot exam using monofilament Foot exams using Doppler machine 83.06 67.13 20.20 94.01 44.22 13.35 7.78 77.94 57.35 3.70 90.44 30.15 8.82 4.41 0.169 0.034 <0.001 0.141 0.003 0.155 0.173 Among those who performed at least one test (table 8), results showed a statistically significant difference between the two groups for the number of fasting blood sugar tests using glucometer. The intervention group declared an average of having been tested with glucometer which was more than twice that of the control group (p<0.0001). There was also a significant difference between the two groups as regards the mean number of HbA1c performed in the previous 12 months against the control group. Even though participants from the control area seemed to have had more foot exams than participants from intervention area, the difference was not statistically significant. 26 Table 8 ‐ Mean number of test in the previous 12 months (±se) Variables1 FBS using Glucometer FBS done in lab HbA1c test Blood pressure measure Cholesterol or lipid profile done Foot exams using monofilament Foot exams using Doppler machine Intervention area Control area p 8.85(±0.53) 2.52(±0.12) 0.26(±0.03) 8.11(±0.39) 1.65(±0.11) 1.55(±0.19) 1.82(±0.41) 4.49(±0.55) 2.77(±0.38) 0.065(±0.03) 7.12(±0.86) 1.78(±0.30) 4.83(±3.04) 2.83(±1.83) <0.0001* 0.5311* <0.0001* 0.2637 0.6658 0.3057* 0.6109* 1 computed among participants who answer more than 0 Regarding medications (table 9), Metformin was the most cited anti‐diabetic drugs in both groups. However this was more frequently declared by the intervention group (p=0.034). Glibenclamide was more frequently cited by the control group than the intervention group (p<0.001). A big proportion of participants in the two groups gave others drugs than those prelisted. Among those, the three most declared were glicazide (29.6% in the intervention group and 19.9% in the control group), glimeperid (7.9% in the intervention group and 2.9% in the control group) and insulin (3.0% in the intervention group and 0.7% in the control group). Other drugs were cited and are presented in appendix 4. Table 9 ‐ Repartition of participants according to the anti‐diabetes medication declared (%) Variables Metformin Glibenclamide Others None I don’t know Intervention area Control area p 62.23 29.22 41.75 3.98 0.80 52.21 49.26 33.82 2.21 0.00 0.034 <0.001 0.094 0.441* 0.583* * Fisher exact test 11.3% and 9.6% of participants respectively from the intervention and control groups declared themselves as a smoker, without significant difference (p=0.557). 9.4.2‐ Nutritionist‐dietetician Around one third of people from the intervention group (32.8%) declared to have met with a nutritionist or dietetician about a meal plan or diet. This proportion was statistically higher than the 22.1% observed in the control group (p=0.016) even after adjustment for age, gender and income, as well as glycemia control status (p=0.023). Table 10 shows the place where participants saw a nutritionist. Regardless of the group, participants answered more frequently that this was at a public hospital rather than the other places listed. This item was statistically more often cited by the control group than by the intervention group (p=0.005). On other hand, the participants from the intervention group were statistically more likely to have answered ‘district health center’ than in the control group (p=0.018). Nine participants in the intervention group gave a provider other than the ones prelisted. Among those, six cited Handicap International. 27 Table 10 – Health facility where a nutritionist was consulted (%‐n=195) Variables Intervention area Control area p 10.91 56.36 26.67 5.45 1.21 10.00 83.33 6.67 0.00 0.00 1.0* 0.005 0.018* 0.359* 1.0* Private clinic Public hospital District health center Others I don’t know * Fisher exact test Table 11 below shows the given reasons why participants did not visit a nutritionist (from those who answered not to have visited a nutritionist). In the intervention group, the main reason for not visiting a nutritionist was that participants did not know they were supposed to do so (28.1%), followed by the fact they did not feel the need (25.7%). It was not recommended by doctor for 12.1% of participants. The only significant difference between the two groups concerned the statement “do not need”. The participants from control group were more likely to cite this item than the ones from the intervention group (p=0.006). Other answers than those prelisted were proposed. Among those, the main reason cited was that participants were busy or did not have time to consult a nutritionist (3.8% in the intervention group and 2.9% in the control group). The others answers are presented in appendix 5. Table 11 – Reasons for not having visited a nutritionist (%) Variables Intervention area Control area p 4.14 12.13 13.31 28.11 25.74 22.19 2.83 17.92 8.49 25.47 39.62 13.21 0.773* 0.128 0.185 0.596 0.006 0.044 Too expensive Not recommended by doctor Do not feel it was important Did not know I was supposed to Do not need Others * Fisher exact test 9.4.3‐ Education session The proportion of participants who have never attended an education session was statistically higher in the control group than in the intervention group with 67.2% and 43.1% respectively (p<0.001). This difference remains significant even after adjustment for age, gender and income as well as glycemia control status and BMI (p<0.001). Among those who declared to have attended an education session at least once, the mean number of sessions was 2.82 (± 0.16) in the intervention group, which was not statistically different than 2.22 (± 0.35) in the control group (p=0.1658). Figure 4 presents the repartition of answers about origin of diabetes educators. The control group mostly declared the hospitals as education providers (p<0.001) while the intervention group cited more often the district health centers. Table 12 presents the other answers cited that those prelisted. Note that Handicap International was cited as provider of educators in 15.5% of case in the intervention group. BHWs played also this role for 2.8% of participants of the intervention group. 28 Figure 4‐ Origin of diabetes educators (%) 80 Intervention 68,18 70 Control 60 50 44,06 40 34,27 27,97 30 20 10 11,36 11,36 5,59 4,55 4,55 0 0 Private clinic Hospital District health center Table 12 “other” category (%) HI BHW Others Organized by the government Brokenshire nurse 9.4.4‐ Payment of diabetes care Other I don’t know Intervention group 15,51 2,78 0,99 0,8 0,2 Control group 0 0 1,47 0 0 More than two thirds of participants from both of the study zones have already had a problem paying for diabetes care (68.8% in the intervention group and 72.1% in the control group – p=0.462). Among them (table 13), more than two thirds stated that they took out a loan or have borrowed or asked for money at least once to pay for diabetes care. Table 13 ‐ Mean found to pay diabetes care (%) Variable Intervention area Control area P 65.03 20.81 6.36 69.65 25.72 3.47 73.47 21.43 11.22 69.39 21.43 2.04 0.117 0.894 0.105 0.960 0.385 0.370* Loan or borrow money from anybody Pawn any property Sell any property Ask for money from anybody Other government Other * Fisher exact test 29 9.5‐ Knowledge about health care services proposed by barangay health centre Table 14 presents the proportions of participants distributed according declared health care services which may be found in barangay health centers. In the intervention group, the two most cited services were immunization/well‐baby service and general medical consultations, followed very closely by pre‐natal care. This result is coherent with the high percentage of female participants. Only one service presents a significant difference between the two study areas. General medical consultations were more frequently declared by the intervention group (31.8%) than the control group (17.7% ‐ p=0.001). In the “other” category, the most frequent answers were linked to diabetes and regrouped into the term “diabetes consultation”. This concerned 38.8% of the participants from the intervention group and only 8% in the control group. This difference is statistically significant (p<0.001). The others answers are presented in appendix 6. Table 14 ‐ Distribution of sample according to health services declared (%) Variable Intervention area Control area p 14.71 28.43 31.81 31.81 5.77 45.33 13.97 29.41 31.62 17.65 5.15 13.97 0.828 0.822 0.966 0.001 0.781 <0.001 TB consultation and medications Pre‐natal care/mother’s disease Immunization/Well‐baby General medical consultations Dental services Others 9.6‐ Most effective means of notification for upcoming events in the barangay health centre In light of the results below, the most relevant means of notification , according to the interviewees, is through house‐to‐ house visits. Table 15 ‐ Way of notification (%) Variable Intervention area Control area p 71.17 3.58 3.78 7.16 3.98 8.55 69.85 1.47 3.68 8.82 2.94 9.56 0.764 0.210 0.956 0.513 0.800* 0.712 House‐to‐house visit Poster Leaflets Meeting Recorrida 6 Other * Fisher exact test Respondents gave some responses other than the ones prelisted. Table 16 presents the percentages of each of these responses among the total sample. 6 Recorrida is a way of public announcement using a megaphone while riding a vehicle.. 30 Table 16 – Other Ways of notification mentioned by respondents (%) Variable Invitation letter Text message Senior citizen organisation/Barangay council/Purok chairman Health center/BHWs Telephone call Meeting Monthly information Intervention group 3.78 1.59 0.99 0.80 0.60 0.20 0.20 Control group 5.88 0.74 0.74 1.47 0.00 0.74 0.00 31 X‐ DISCUSSION 10.1‐ Objectives and main results This study provides baseline values for CVD project monitoring indicators. Table 17 summarizes the values obtained and those expected at the end of the project. Table 17 – Baseline and final expected values of monitoring indicators Final Baseline Expected Indicators in the logical framework Indicators used values values (2010) (2013) Indicator 5: 20% Increase of persons with diabetes HbA1c<6.5% BMI<23 kg.m² Waist circumference <80 cm among females OR <90 cm among males 28.23% 34.26% 33.88% 41.11% 20.76% 24.91% ‐ achieving 130/80 mmHg as blood pressure Blood pressure <130/80 mmHg 24.85% 29.82% ‐ doing 30‐minute physical activity at least 3 times a week Moderate category of IPAQ = at least 30‐minutes moderate level physical activity 5 times a week 61.94% 74.33% 20.68% 31.02% ‐ with HbA1c<6.5% ‐ with BMI< 23 kg.m² ‐ with acceptable waist circumference Indicator 6: 50%‐increase of persons with diabetes with diabetes knowledge score > 60% Knowledge score ≥5 The indicators, as written in the logical framework, were defined without information about the actual values. Due to this survey, a value close to the reality was computed for each of the indicators listed in the table. Reaching 75% of persons with diabetes with adequate physical activity or more than 40% with adequate BMI seems ambitious. In addition to providing baseline data for indicators, this study also gave a description of people with diabetes living in the study area in terms of socio‐demography, anthropometry and glycemic control. The mean level of HbA1c and the proportion of patients with poor glycemic control of levels of HbA1c (≥6.5%) all indicated that glycemic control was unsatisfactory in the two groups. This fact may be explained by poor diabetes management: in the intervention group, around one participant out of 10 declared not to have had a check‐up the previous year and 56.7% had less than 4 checks‐up the previous year. The high level of uncontrolled diabetes may explain the high rate of people who declared at least one complication (67.1%). Additionally, 51.6% of participants declared to be affected by hypertension, 22.2% by retinopathy, 11.6% by heart disease, 8.6% by nephropathy and 6.4% by neuropathy. The rate of female respondents was high (69.2%). Regarding the entire sample, 63.0% of women were homemakers or retired, against 44.6% of men. Men who generally work outside from their home may have less opportunity to participate in the research. This may explain the high rate of female respondents. Generally speaking, women participate more in surveys about health than men. However, a cross‐sectional study conducted in Luzon in 2003 to estimate the prevalence of diabetes mellitus and impaired glucose tolerance showed that the prevalence of diabetes was higher among females than males. (8). Therefore the high rate of participation of females in our study may partly be related to high prevalence of diabetes among this specific population. A further prevalence study is necessary to test this assumption. 32 10.2‐ Limitations Representativeness or external validity Initially the survey was designed to be representative of diabetics visiting study zone health centers using a sampling method. However, the project had sufficient funds to recruit all the diabetics registered in the master list by BHWs. Unfortunately some diabetics registered did not actually have diabetes. However, walk‐in people who met the inclusion criteria were included for replacement. The master list was therefore (1) not reliable and (2) not exhaustive. The source population is thus unclear and this prevents extrapolating data to all diabetics visiting the health centers. The figures presented in this report should be read as concerning only the sample and not be used to speak about all diabetics. Nevertheless, this survey was designed to evaluate the CVD project and provide baseline value to indicators of the CVD project. This will be repeated at the end of the project in 2013. If the 2013 sample is the same, or at least comparable with 2010 sample, this can allow for some conclusions to be drawn on the effectiveness of the project. Sample size The non‐statistical differences between the intervention and the control groups need to be taken with caution. Indeed the sample size of the control group was small, which means that the statistical power of comparisons is low. In other words, the ability of statistical tests to detect a significant difference is reduced. Thus, some proportions seem different between the two groups (intervention and control) but the statistical tests did not result to a significant difference. If the sample had been bigger, perhaps the difference could have been significant. In the current study only a raw difference of 15 points or above between two percentages (P2‐P1≥15) can be detected as statistically significant. Difference between intervention group and control group The main criterion of the study is the rate of HbA1c. The CVD project has as goal to increase the percentage of diabetics with HbA1c<6.5% by the end of the project. To assure that the possible increase observed at the end of the project is linked to the project, it is necessary to have a control group in all respects similar to the intervention group, except for the project. This design permits to control confounding factors (other factors explaining the difference observed i.e. age, gender, education level, economic level etc.). The only difference between the two groups is thus the presence or the absence of the project. In our study, the intervention group and the control group did not have the same characteristics. The control group was poorer than the intervention group, had a lower level of education and had a higher mean of HbA1c. Thus the intervention and control groups are not strictly comparable. This is a limitation when evaluating the project. The after‐ study analysis will need to use multivariate analysis to adjust on confounding factors and make artificially groups comparable. Limitation due to the start of the project in 2007 The high mean of HbA1c and the high percentage of uncontrolled glycemia in the control group may be explained by poorer diabetes management than those of the intervention group. The results show that the control group performed less frequent routine tests than the intervention group. This difference was particularly significant for HbA1c test and fasting blood sugar test using glucometer. The survey participants from the control area were less likely to have had at least one education session or to have ever seen a nutritionist. These differences may be partly explained by the project implemented in the intervention area since 2007. The impact of the project is also clear when we notice that the participants from the intervention group are more likely to declare that the District Health Center provides nutritionist/dietetician and education sessions while the ones from the control area declared more often the hospital as provider of these sessions. The first phase of the project aimed at building local skills in terms of diabetes care management, targeting the three levels of diabetes prevention. For more details on the phase 1 of the project, please refer to appendix 7. It would have been wise not to have chosen the pilot Barangays as the intervention area to test the effectiveness of the CVD project. An area free from any influence of the first phase of the project would have been more relevant to assess the effectiveness of the CVD project. 33 10.3‐ Comparisons with literature Although the proportion of participants with uncontrolled glycemia is still very important, the proportion observed in our sample is lower than what it is usually found in existing literature, and also lower than the measures taken by Handicap International in 2007 and 2009. For South‐East Asian countries, rates of diabetics with poor glycemic control (HbA1c≥7%) vary from one to another. In current literature, the range of diabetics with poor glycemic control (HbA1c≥7%) is 59% to 81% (21‐26). Using this threshold, 57.7% of our participants in the intervention area would be considered as having poor control glycemic but this is a lower percentage than for South‐East Asia generally. The study of Ng et al. showed that ethnic difference exists with regard to diabetic control as reflected by HbA1c levels among people with diabetes living in same country (27). We can assume this ethnic difference exists between countries of South‐east Asian, explaining in part the range observed above. The DiabCare‐Asia 1998 study collected data from 230 diabetes centers distributed in 12 Asia countries. This study stated that the mean central HbA1c was 8.6(±2.0)% for the entire sample and 65% had HbA1c>7.5% compared to 64.7% in our study.(28) In the DiabCare‐Asia study, the mean of onset age was 48.7 ± 12.2 and the mean of BMI was 24.4± 4.0 kg.m². Theses values are similar to those obtained in our study. In addition the DiabCare‐Asia showed that 27% had systolic blood pressure >140 mmHg and 10% had diastolic blood pressure > 90 mmHg, while our values are respectively 54.7% and 21.7% for intervention group and 58.8% and 24.3% for the control group. Specifically regarding the Philippines, this same study stated that the mean of HbA1c was of 8.9% in the Philippines and 84.0% of Filipino sample had HbA1c above 7% (in our study. respectively 7.8% and 57.7%). The articles do not explain the differences observed in our study. The study of Lantion‐Ang carried out in the Philippines in 2000 provides information about diabetes control using HbA1c level. The mean HbA1c level in Lantion‐Ang’s 2000 study was 8.9% and 73% of diabetics had HbA1c value above 7.4% (29). With this threshold, our study shows a lower proportion (53.1% in the intervention group and 65.4% in the control group). The sample used in Lantion‐Ang’s 2000 study was older than ours (59 years old versus 57 years old. respectively) and more corpulent (60% had BMI≥25 kg/m² versus 44.4% in the intervention group and 36.3% in the control group). The main difference is the selection method. In Lantion‐Ang’s 2000 study the diabetics were included in a randomly selected hospital. In our study, people with diabetes were selected using a list created from the patients known by the barangay health workers. We can suppose that those who consult at hospitals are more affected by diabetes complications and so their HbA1c value is higher. Moreover the survey was conducted in a specific venue, meaning that people with diabetes had to travel to the survey venue to participate. Thus we can easily assume that people with a diabetic foot or blindness or other disabling conditions were less able to attend. In addition, persons with diabetes most affected by complications were voluntarily excluded from the survey for logistic reasons. The proportion of people with diabetes with good glycemic control is certainly lower in the entire population of patients with diabetes. On other hand, Handicap International has previously measured HbA1c in 2007 and 2009 among 268 and 289 persons with diabetes respectively from the intervention area used in this survey. The proportion of persons with HbA1c below 6.5% was respectively 26.5% and 26.6% and the mean of HbA1c values was 8.7% (±2.8%) in 2007 (this data was not available). These two first values are to be compared with 28.3% of our study. If the project explains the difference observed between 2007 and 2010, it cannot explain the difference observed between 2009 and 2010, since only 7 months had elapsed between the two measures, which do not seem sufficient to observe such a difference. The variation may be explained by the difference of methodology used to obtain these two values. In 2007 and 2009, the tests were done in a lab at San Pedro Hospital in Davao while in 2010 a portative device using boronate assay by spectrophotometry was used. At San Pedro Hospital, the assay measures both HbA1c and hemoglobin. The HbA1c measurement is based on a turbidimetric inhibition immunoassay principle, and the measurement of total hemoglobin is based on a modification of the alkaline hematin reaction. Using the values obtained for each of these two analytes (in g/dL), the percentage of the total hemoglobin that is glycated is calculated and reported as %HbA1c. The final HbA1c result has been standardized to the results obtained in the Diabetes Control and Complications Trial (DCCT). The Clover A1c System (appendix 2) used in the present study is a fully automated boronate affinity assay certified by the National Glycohemoglobin Standardization Program due to its traceability to the Diabetes Control and Complications Trial Reference Method. Nevertheless, HbA1c 34 results from the two analytical techniques are standardized on the DCCT. The results are then comparable. The difference observed is not linked to the measure method. Concerning the difference observed with the 2007 data, it may be linked to the impact of the first phase of the project. However it may be also due to a difference of sample profile. The 2007 respondents were more likely to present abdominal obesity (70.0% in 2007 versus 57.1% in 2010), there were less females (61% in 2007 versus 70% in 2010) and they were poorer: 70% declared to earn less than 5.465 Php in 2007 versus 54% in 2010. Moreover, one quarter of respondents declared not to be employed in 2007 against 4% in 2010. The proportion of respondents with moderate physical activity level seems important in our sample. In Indonesia, only 4.7% of survey participants had physical activity considered as sufficient, namely above 600 MET, which corresponds to the moderate category of IPAQ (30). In the Philippines, Baltazar et al. stated a high percentage of persons with diabetes with physical inactivity: 78.2% among males and 69.8% among females (8), which is contrary to this study’s data. The precise methods used to measure the physical activity level were not described in these two articles. Moreover there is not sufficient available data that allow sample comparisons. It is thus difficult to identify the underlying reasons for this difference. The short version of IPAQ was chosen for several reasons: (1) it tends to capture physical activity done during leisure, domestic and gardening, the work‐related activity and transport‐related activities; (2) it was the most feasible approach to evaluate physical activity level with the funds available; (3) to avoid having a too long questionnaire. The IPAQ short form was designed for population surveillance of physical activity among adults and the IPAQ committee does not recommend using this tool as an outcome measure in small scale intervention studies. In our survey, the idea was not to measure precise individual changes in physical activity but to have a general idea of the proportion who respect moderate physical activity level. 35 XI‐ CONCLUSION Despite the limitations as described above, this study provides a first insight on the people living with diabetes in Davao City. With almost 72% of diabetics having uncontrolled glycemia, this study shows the relevance of the CVD project. As a baseline, this study provides comparison elements for the 2013 survey in order to test effectiveness of the CVD project with the percentage of diabetics with HbA1c<6.5% as effectiveness criterion. XII‐ SOME RECOMMENDATIONS FOR THE 2013 SURVEY 1‐ Use the same device to test HbA1c rate in order to ensure the comparability of results between the two surveys 2‐ As far as possible, try to re‐recruit the 2010 respondents to improve the power of statistical tests 3‐ If it is not possible to re‐recruit the 2010 respondents, try to recruit as many respondents as possible, especially in the control area, for the same reason as above 4‐ Data analysis should take differences observed between the two groups into account. Statistical adjustment on education and economic level is necessary. 36 XII‐ REFERENCES 1. 2. 3. 4. 5. 7. 8. 9. 10. 11. 12. 13. 14. Shaw JE. Sicree RA. Zimmet PZ. Global estimates of the prevalence of diabetes for 2010 and 2030. Diabetes Res Clin Pract. 2010 Jan;87(1):4‐14 Roglic G. Unwin N. Mortality attributable to diabetes: Estimates for the year 2010. 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Epidemiology of diabetes mellitus in Western pacific region: focus on Philippines. Diabetes Res Clin Pract. 2000 Oct;50 Suppl 2:S29‐34. Mihardja L.. Delima. Siswoyo H.. Ghani L.. Soegondo S. Prevalence and Determinants of Diabetes Mellitus and Impaired Glucose Tolerance in Indonesia (A Part of Basic Health Research/Riskesdas) Acta Med Indones‐Indones J Intern Med Vol. 2009 Oct; 41(4):169‐74 39 APPENDIX 1: THE QUESTIONNAIRE q Thank you for coming. This survey is about your experiences as a person with diabetes. Gender Male Female Date of Birth Month / Day / Year Date of Conduct TD: M D Y P WC: Patient Code PC: B A. Employment Status Check one q 1. Working full‐time (40 hours or more a week) q 2. Working part‐time (less than 40 hours a week) q 3. Unemployed or laid off and looking for work q 4. Unemployed and not looking for work q 5. Homemaker q 6. Retired/Pensioner q 7. Disabled, not able to work q 8. Others (Please specify): ______________ B. Educational Attainment Check one q 1. Some elementary q 2. Elementary q 3. Some high school q 4. High school q 5. College q 6. Some College/Vocational q 7. Postgraduate q 8. No formal education C. Family History of Diabetes Check all that apply q 1. Mother q 2. Father q 3. One sibling q 4. Two or more siblings q 5. Second degree relatives q 6. None q 7. I don’t know 1. In average what is the household income per month? _________ Pesos (Round off to the nearest 500) 2. In your household, do you have: Check all that apply q 1. Ref q 2. Computer q 3. TV q 4. Motorized vehicle q 5. Washing machine q 6. Aircon Blood Pressure BP: L 1 2 3 A Remarks: Anthropometry H: W: 1 2 3 Gown Code R 1 2 3 A HbA1c Comments Quality Checked/Comments D. Economic status 7. None of the above Data gathered by: Interview: Blood Pressure: Anthropometrics: Blood Test: QC: 40 The Diabetes Survey Section 1 – Nature of Diabetes Section 2 – Diabetes Management and Care 1. When was it when you were first diagnosed with diabetes? (Your best estimate is fine) M D Y 2. What were your symptoms during the time that you were diagnosed? Please check all that apply. DO NOT READ ALOUD. q a. I frequently urinate q b. I am always thirsty q c. I am always hungry q d. I suddenly lost weight q e. I am easily fatigued q f. I have on and off blurring of vision q g. I have vaginal itchiness q h. My other symptoms are: _________________________________ q i. I don’t remember. 3. What are the complications that you are diagnosed with now? Please check all that apply. DO NOT READ ALOUD. q a. Neuropathy / Nerve damage q b. Retinopathy / Eye damage q c. Nephropathy / Kidney damage q d. Hypertension q e. Heart disease q f. Erectile Dysfunction (for males) q g. I have vaginal itchiness q h. Others (please specify) _________________________________ q i. None q j. I don’t know If you checked (D) Hypertension, please proceed to No. 4. If you are not diagnosed with hypertension, please proceed to No. 7. 4. When was it when you were diagnosed with hypertension? (Your best estimate is fine) M D Y 5. Do you take prescribed medicines for your hypertension? q Yes, please proceed to No. 6. q No, please proceed to No. 13. q No, please proceed to No. 7. 6. What are your prescribed medicines for hypertension currently? Ask if they brought their meds or prescription. Write MMK if can’t remember one of two or more meds. q a. Metroprolol q b. Captopril q c. Others (please specify) _______________ q d. I don’t know 7. How many times did you have a regular check‐up with any doctor regarding your diabetes in the past twelve months? Please exclude those times that you went because you felt ill. If none, please write 0. ______ 8. How many times did you undergo the following lab tests in the past twelve months? Please exclude those that were done because you felt ill. If no tests were done, please write 0. If none at all, please cross out the table. Name of Test No. of tests a. FBS using glucometer b. FBS done in the lab c. HbA1c d. Blood pressure e. Cholesterol or lipid profile f. Foot exam using monofilament g. Foot exam using a Doppler machine 9. What are your anti‐diabetes medications today whether you are taking them or not? Please check all that apply. q a. Metformin q b. Glibenclamide q c. Others (please specify) ______________ q d. None q e. I don’t know 10. Do you currently smoke? q Yes q No 11. Did you ever see a nutritionist‐dietitian to learn about a diabetic meal plan or diet? q Yes, please proceed to No. 12. 41 The Diabetes Survey 12. From which health facility is the nutritionist with whom you consulted? Please check all that apply. Then proceed to No. 14. q a. Private clinic q b. Hospital q c. District health center q d. Others (please specify) _______________ q e. I don’t know 13. Why haven’t you seen a nutritionist‐dietitian? Please check all that apply. q a. Consultation is expensive. q b. It was not recommended by my doctor. q c. I did not feel it was important. q d. I did not know I was supposed to q e. I don’t need it because my doctor tells me about my diet already. q f. Others (please specify) _______________ 14. How many times have you attended a diabetes education session since diagnosis? If none, please write 0 and proceed to No. 16 _________ 15. From which health facilities were the diabetes educators? Please check all that apply. q a. Private clinic q b. Hospital q c. District health center q d. Others (please specify) _______________ q e. I don’t know 16. What are the health care services of your barangay health center? Please check all that apply. DO NOT READ ALOUD. q a. TB consultation and medications q b. Pre‐natal care/ mother’s classes q c. Immunization/Well‐baby q d. General medical consultations q e. Dental Services q f. Others (please specify) _______________ q g. None of the above q h. I don’t know 17. What is the very best way for the health center to notify you of upcoming events? Choose only one. Do not read aloud. q a. House‐to‐house visit q b. Poster q c. Leaflets q d. Parade q e. Meeting q f. Recorrida q g. Others (please specify) _______________ q h. None of the above q i. I don’t know 18. Have you ever had a problem in paying for your diabetes care? q Yes, please proceed to No. 19. q No, please proceed to No. 20. 19. Have you ever had to do any of the following to pay for your diabetes care? Please check all that apply. q a. Loan or borrow money from anybody q b. Pawn any property you have (cellphone, jewelry, appliance, etc.) q c. Sell any property you have (cellphone, jewelry, appliance, etc.) q d. Ask for money from anybody (including your children) q e. Lingap and other government programs q f. Other means to pay for diabetes care outside of your means (please specify) ____________________________ 20. OBSERVE ONLY: Write 0 if none. Right Left Above knee Below knee Partial foot 42 The Diabetes Survey Section 3 – Diabetes and Disabilities Section 4 – Diabetes Knowledge Introductory phrase: The next questions ask about difficulties you may have doing certain activities because of a HEALTH PROBLEM. 21. Do you have difficulty seeing, even if wearing glasses? q 0. No difficulty q 1. Some difficulty q 2. With a lot of difficulty q 3. Cannot at all 22. Do you have difficulty hearing, even if using a hearing aid? q 0. No difficulty q 1. Some difficulty q 2. With a lot of difficulty q 3. Cannot at all 23. Do you have difficulty walking or climbing steps? q 0. No difficulty q 1. Some difficulty q 2. With a lot of difficulty q 3. Cannot at all 24. Do you have difficulty remembering or concentrating? q 0. No difficulty q 1. Some difficulty q 2. With a lot of difficulty q 3. Cannot at all 25. Do you have difficulty with self‐care such as washing all over or dressing? q 0. No difficulty q 1. Some difficulty q 2. With a lot of difficulty q 3. Cannot at all 26. Using your usual (customary) language, do you have difficulty communicating, for example understanding or being understood? q 0. No difficulty q 1. Some difficulty q 2. With a lot of difficulty q 3. Cannot at all Introductory phrase: The next questions are intended to measure the level of diabetes knowledge. Kindly give the best answer for each item. 27. My target fasting blood sugar level is 1. 5 mmol/L or 90 mg/dL and below 2. 6 mmol/L or 108 mg/dL and below 3. 7 mmol/L or 126 mg/dL and below 4. 8 mmol/L o 144 mg/dL and below 28. My target blood pressure is 1. Below 110/70 3. Below 130/80 2. Below 120/80 4. Below 140/80 29. The time I spend daily for exercise should be 3. 20 minutes 1. 10 minutes 2. 15 minutes 4. 30 minutes 30. The blood test ideal for monitoring my blood sugar is 1. HbA1c 3. OGTT 2. FBS 4. RBS 31. My target waist circumference should be 1. Below 70 cm 3. Below 90 cm 2. Below 80 cm 4. Below 100 cm 32. The best way to prevent my foot from being amputated is to 1. Take the antibiotics prescribed by my doctor if I have a wound 2. Check and wash my feet everyday 3. Have my feet inspected by my doctor every time I visit 4. Wear proper shoes for protection 33. My kidneys should be monitored through 1. Blood creatinine once a year 2. Routine urinalysis once a year 3. Blood cholesterol once a year 4. ECG once a year 34. During regular meals, one‐half of my plate should be filled with 1. Rice 2. Meat such as fish, pork or beef 3. Vegetables 4. Fruits 43 The Diabetes Survey Section 5 – Physical activity Introductory phrase: The following questions refer to physical activities that you did in the last seven (7) days. There are no right or wrong answers. Walking includes at work and at home, walking to Vigorous activities are those that take hard travel from place to place, and any other walking physical effort and make you breathe much that you might do solely for recreation, sport, harder than normal. exercise, or leisure. Example: heavy lifting, digging, aerobics, or fast bicycling 39. During the last 7 days, on how many days did you walk for at least 10 minutes at a 35. During the last 7 days, on how many days did time? you do vigorous physical activities for at least 10 minutes at a time? days q No walking. Please go to No. 41. days q No vigorous physical activities. Please go to No. 37. 40. How much time did you usually spend walking on one of those days? 36. How much time did you usually spend doing Minutes q Don’t know or not vigorous physical activities on one of those sure Hours days? Minutes q Don’t know or not sure Hours Sitting includes time spent at work, at home, while doing course work and during leisure time. This may include time spent sitting at a desk, Moderate activities refer to activities that take visiting friends, reading, or sitting or lying down to moderate physical effort and make you breathe watch television. somewhat harder than normal. Examples: carrying light loads, bicycling at a 41. During the last 7 days, how much time did regular pace, or doubles tennis you spend sitting on a week day? Minutes q Don’t know or not 37. During the last 7 days, on how many days did sure Hours you do moderate physical activities like? Do not include walking. days q No moderate physical activities. Please go to No. 39. 38. How much time did you usually spend doing moderate physical activities on one of those days? Minutes q Don’t know or not sure Hours ‐‐‐ End of Questionnaire ‐‐‐ Thank the respondent. Take the BP and note values on the first page. Give this to the respondent and ask him/her to proceed to the measurements area with this questionnaire. 44 APPENDIX 2: BLOOD TESTING FOR HEMOGLOBIN A1C General 1. Blood should be collected only by a hired nurse or medical technologist trained on this protocol and the use of the HbA1c analyser. 2. Capillary blood from a finger prick will be tested. 3. Results will be released immediately after the blood test. 4. Patients will be advised that fasting is not required. Materials / Equipment 1. HbA1c Analyzer ( Clover A1c) 2. Lancing Device 3. Disposable Lancets 4. 70% Ethyl alcohol 5. Cotton balls 6. Extra HbA1c Test Result Forms 7. Blood test result summary form 8. Glue / Stapler with staple wires Principle behind the HbA1c Analyzer (Clover A1c) Clover A1c System is a fully automated boronate affinity assay certified by the National Glycohemoglobin Standardization Program due to its traceability to the Diabetes Control and Complications Trial Reference Method. It determines the percentage of haemoglobin A1c in human whole blood. The test cartridge is composed of a Cartridge and a Reagent Pack containing the reagents with a collection leg for blood sample collection. The Reagent pack is pre‐filled with reaction solution and washing solution. The reaction solution contains agents that lyses erythrocytes and bind haemoglobin specifically, as well as a boronate resin that binds cis‐diols of glycated haemoglobin. Blood sample is collected at the collection leg of the Reagent Pack. The Reagent pack is inserted into the Cartridge, where the blood is instantly lysed releasing the haemoglobin and the boronate resin binding the glycated haemoglobin The assembled Cartridge is inserted into the analyser and rotated so that the blood sample mixture is placed at the measurement zone of the Cartridge, where the amount of total haemoglobin in the blood sample is measured by the reflectance of the photo sensor LED (Light Emitting Diode) and PD (Photo Diode). Then, the assembled cartridge is rotated so that the washing solution washes out non‐glycated haemoglobin from the blood sample, thus the amount of glycated haemoglobin can be photometrically measured. The ratio of glycated haemoglobin with respect to total haemoglobin in the blood sugar is calculated. Calibration 1. Calibrate the analyser at the start of every blood testing day. 2. Perform calibration of the analyser using the calibrator cartridge provided with the machine. 3. Do not perform blood tests when the LCD displays shows ERROR. 4. Common reasons for ERROR in calibration are: defective calibrator or low light / defective light 5. Inform the data‐gathering head once this occurs 6. 2 sets of machines with calibrators will be prepared for the research in preparation for this. 45 Performing the blood test and releasing the result. 1. Apply alcohol to the finger and let dry before pricking. 2. Place the blood sample in the tip of the collection leg. 3. Place cotton ball with alcohol on the pricked finger once enough blood is collected. 4. Let the respondent wait for the results. 5. Write the result in the Result Form and check the corresponding interpretation and recommendations. 6. Show the filled up Result form to the data‐gathering in‐charge for verification before giving the result to the respondent. 7. Write the result on the front‐page of the survey questionnaire. 8. Record the result in the Blood test summary sheet. 46 APPENDIX 3: OTHERS SYMPTOMS DECLARED BY PARTICIPANTS Table 18 Other Symptoms (%) Intervention Dizziness 24.06 Limb numbness 13.68 Itchiness 8.02 Weakness 7.08 Fever or sweating 7.08 Headache 5.66 Pain 4.72 Slow healing wound 4.72 Cannot sleep 2.83 Foot problems 2.83 Vomiting 2.36 Cough 1.89 Dryness 1.42 Cramps 1.42 Urine system problem 0.94 Rashes 0.94 Gestational diabetes 0.94 Slow weight loss 0.94 Pale 0.94 Felt like floating 0.94 Discovered during 0.94 other examinations Collapsed 0.94 No appetite 0.94 Difficulty in breathing 0.47 Asthma 0.47 Mild stroke 0.47 Did not feel well 0.47 Swelling 0.47 Skin lesion 0.47 Oedema 0.47 Tachycardia 0.47 Nausea 0 Irritable 0 Diarrhoea 0 Control 22.73 9.09 13.64 4.55 3.03 7.58 1.52 9.09 1.52 4.55 1.52 3.03 3.03 0 0 1.52 0 0 0 1.52 Table 19 Others complications (%) Lungs problem Gastropathy Dizziness Fatty liver Gallbladder Goiter Tuberculosis Anemia Asthma Cannot Sleep Difficulty breathing Foot infection Headache Hypercholesterolemia Numbness Rheumatic arthritis Tinnitus Mild stroke 1.52 1.52 0 1.52 0 0 0 3.03 0 0 0 1.52 1.52 1.52 Intervention group 1.59 0.80 0.40 0.40 0.40 0.40 0.40 0.20 0.20 0.20 0.20 0.20 0.20 0.20 0.20 0.20 0.20 0.00 Control group 2.21 0.00 0.00 0.74 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.74 0.00 0.00 1.47 47 Table 20 Other antihypertensive drugs (%) Amlodipine Losartan Nifedipine Enalapril Aspirin Telmisartan Felodipine Irbesartan Atenolol bepridil Imidapril Verapamil Lacidipin Intervention area 9.54 7.95 3.38 2.78 1.79 1.19 0.99 0.80 0.60 0.60 0.60 0.40 0.40 Control area 5.15 8.09 5.88 1.47 1.47 0.74 1.47 0.00 0.00 0.00 0.00 0.00 0.00 0.40 0.20 0.20 0.20 0.00 0.00 0.00 0.00 0.20 0.20 0.20 0.20 0.20 0.20 0.20 0.20 0.20 0.20 1.47 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.00 0.74 0.74 Lozartan + Hydrochlorothiazide Candesartan Furosemide Hydrochlorothiazide Imidapril + Hydrocholorthiazide Indapamide Moexipril olmesartan Perindopril Ramipril Atorvastatin Clonidine Potassium Valsartan + Hydro Benidipine hydrochloride Rauwolfia_alkaloids 48 APPENDIX 4: OTHER ANTI‐DIABETICS DRUG THAN THOSE PRELISTED Table 21 Other anti‐diabetic drugs (%) Glicazide Glimeperid Insulin Glipizide Herbal medicines Rosiglitazone Sitaglitin Acarbose Cilostazol Imidapril Losartan Metoprolol Pioglitazone Vildaglipin Unknown generic Intervention group 29.62 7.36 2.98 1.79 0.40 0.40 0.40 0.40 0.20 0.20 0.20 0.20 0.20 0.20 0.99 Control group 19.85 2.94 0.74 1.47 2.21 0.00 0.00 0.74 0.00 0.00 0.00 0.00 2.94 0.00 1.47 49 APPENDIX 5: OTHER REASONS FOR NOT VISITING THE NUTRITIONIST Table 22 Other reasons for not visiting the nutritionist (%) Busy/ no time Do not know Seminar/meeting Informed by acquaintance Read Lazy to consult Controlled by himself Informed by BHW Forgot Do not like it Do not where to consult Do not have the chance to consult Cannot move around No money Too far intervention group 3.78 2.39 1.79 0.99 0.99 0.80 0.40 0.40 0.20 0.20 0.20 0.20 0.20 0.20 0.00 control group 2.94 0.74 0.00 0.74 0.74 0.00 0.74 0.74 0.00 0.00 0.74 0.00 0.00 0.74 0.74 APPENDIX 6 : OTHER BARANGAY HEALTH CENTER SERVICES DECLARED BY RESPONDENTS Table 23 Other services available at the Barangay health office (%) Diabetes consultation Other services Family planning Nutritional consultation Vaccine Hypertension consultation Seminar Intervention group 38.77 6.16 1.99 1.19 0.8 0.6 0.4 Control group 8.09 2.94 1.47 0.74 0 0 0.74 50 APPENDIX 7: PHASE 1 LOGICAL FRAMEWORK: FURTHER DETAILS The very specific nature of diabetes means that certain important strategic choices have had to be made concerning the implementation of the project. On the one hand this is a severe and relatively recent epidemic. Indeed, diabetes has only recently become an issue in developing countries (over the past twenty years). According to experts, despite its rapid exponential spread, the epidemic is really only just beginning, given the huge lifestyle changes that are currently taking place. This very particular situation means that healthcare services, which are already struggling to deal with public health problems, will be saturated by the growing demand for care for chronic diseases. It is therefore important to anticipate these issues and modify care strategies accordingly. Using a cross‐disciplinary approach, the project aims to strengthen skills and put people with diabetes at the heart of the process by building their capacities to control and self‐manage their disease. This should, in turn, take the pressure off healthcare services and avoid the complications and morbidities which can represent a heavy financial burden for the family and healthcare services in general. On the other hand, the very nature of diabetes as a chronic disease means it is crucial to start educating the population from a very early age. This requires behavioural change in terms of lifestyle but also in terms of the consumption/use of healthcare. This means people have to be vigilant on a daily basis, even if they do not yet have any apparent symptoms. For all these reasons, the project’s overall objective is for people with diabetes to be able to self‐manage their disease and live a normal life. In order to meet this objective, three areas of action will be developed over the course of the project: 1. Primary prevention: Avoiding the onset of the disease amongst people at risk. The objective is to control the epidemic and slow down its spread by warning and educating people at risk as early as possible. Two specific groups will be included in the activities. Firstly, people immediately at risk of developing diabetes (people who are overweight, have a family history of diabetes, people who do little or no physical exercise, people with poor life hygiene etc.); and secondly, other children and adolescents, through targeted awareness‐raising in schools and the promotion of maintaining good health. Several activities will take place in order to reach this objective: - An education and prevention kit on health, life hygiene and nutrition. This will be produced for use in primary and secondary schools - Community awareness‐raising work will be carried out with the help of community workers and the "Diabetes Club", an organisation made up of people with diabetes - Work will be carried out in partnership with the Davao town council in order to implement local legislation on diabetes prevention 2. Secondary prevention: Ensuring that people with diabetes do not develop complications The objective is to ensure that people with diabetes fully understand their illness and can develop day‐to‐ day strategies for living a normal life and controlling their blood sugar levels. The following activities will be put into place: - Strengthening local medical services, both on a community level via community health workers, and in district hospitals. Specialised training will be provided for healthcare staff in order to set up a system for support and accompaniment - Improving financial access to medication and laboratory tests. Within the framework of this action, two special activities will take place. Firstly, an economic study into the financial burden on families that the purchase of medication and laboratory tests represents. This study will also aim to provide financial information for setting up a system to reimburse the cost of medication and laboratory tests for the poor. Following these recommendations, a system will be developed 51 - and tested to demonstrate to local authorities how the system would work and how much it will cost, in order to integrate it into the council budget Implementation of daily accompaniment for people with diabetes through the development of peer‐to‐peer activities Definition and implementation of diabetes screening protocols amongst at risk groups 3. Tertiary prevention: Preventing morbidity or mortality in diabetics with complications. The objective is to improve care management for patients who have developed complications and to avoid disabling situations. Several activities will be put into place: Within the tertiary medical services (Davao Medical Center) for medical care: - Definition and implementation of intervention protocols concerning complications linked to diabetes, and the training of those involved in this work - Improving the coordination between specialised services by putting into place coordination tools - Setting up a referral and counter‐referral system for the different people and services involved, both within the hospital and also in district and community services - Creation and circulation of information tools for existing services With those involved in rehabilitation work, for the care‐management of impairments linked to complications brought on by diabetes: - Community‐based rehabilitation services developing tools designed for the care‐management of impairments brought on by diabetes and for the prevention of secondary complications (repeat amputation, ulcers etc.) - Training for Community Based Rehabilitation workers in using these tools - Research into the appropriate technology to be used for dealing with orthopaedic complications in the field of footware, orthoses designed to unload/deweight, adapted socket prostheses and special mobility aids for people with diabetes in developing countries. Training for all those involved (orthopaedic technician, chiropodist, physiotherapist etc.) - Definition and implementation of monitoring protocols in rehabilitation centres, for rehabilitation interventions designed to treat complications 4. Follow‐up and assessment of the action taken to improve diabetes care management. Given the innovative nature of the project, careful attention will be paid to epidemiological monitoring and the assessment of the impact of the different interventions undertaken. - Firstly, specific indicators will be defined - A comprehensive data collection system will be set up by providing a target population sample of diabetics with follow‐up records (these follow‐up records will also allow people with diabetes to follow‐up and control their illness themselves) - The data will then be analysed and an annual report on the diabetes situation in Davao will be produced __________ 52 with the support from Sanofi‐Aventis 53 CVD project evaluation: Baseline diabetes study Davao, Philippines 2010 This report presents the baseline evaluation study of the Cardiovascular Diseases (CVD) project conducted in Davao, Philippines in 2010. The study’s aim was to gather baseline data for indicators 5 and 6 of the expected results 1 of the 2010-2013 CVD project. This study also concerned gathering information on the nature of diabetes and common practices in diabetes management and care, to improve project implementation strategy and data on promoting health care services in the community. The present study is the first part of a before-after here-there study conducted in 10 intervention villages and 5 control villages of Davao City. HANDICAP INTERNATIONAL 14, avenue Berthelot 69361 LYON Cedex 07 T. +33 (0) 4 78 69 79 79 F. +33 (0) 4 78 69 79 94 [email protected]
