An interventional study of Village Health Worker (VHW) Care Model in Cardiovascular Diseases, Hypertension and Diabetes, sponsored by Community Partners International. Completed at 1 site in Burma. Open to participants aged 40 Years to 100 Years. Per ClinicalTrials.gov, last updated 2025-07-31.
Sponsored by Community Partners International · Not applicable, Interventional, and Health services research
The goal of this study is to test a village health worker (VHW) based care model to reduce cardiovascular risk among adults in areas of eastern Myanmar affected by armed conflict. All individuals aged 40 years and above will be invited to participate in this study. Participants will be checked whether they have a history of cardiovascular disease, diabetes (high blood sugar), high blood pressure or risk of developing cardiovascular disease by asking for medical history, measuring blood pressure, weight and height, and blood glucose if necessary. The main question the study aims to answer is:
Does villagers residing in the VHW supported villages have their blood pressure controlled, adherent to therapy and subsequently reduce the risk of developing cardiovascular disease after 5 months of monthly VHW home visits?
Myanmar is a Southeast Asian country which has been struggling with active conflict situation since 2021 - resulting massive internal displacement especially in ethnic areas. It is widely known that Community- and village-health worker (VHW) led interventions have reduced CVD risk in stable areas of low and middle income countries, but have not been adapted for internally displaced people (IDPs) exposed to active conflict. In addition, CVD is the leading cause of death in Myanmar and according to recent national survey, 75% of adults have at least one CVD risk factor.
This cRCT study is a third phase of the "Implementation of a community-led strategy to reduce cardiovascular disease risk among conflict-affected populations in eastern Myanmar" and Phase 1 and 2 have been successfully completed. The VHW care model was developed based on a Causal Loop Analysis (CLA) workshop in Phase 1 (GWU IRB# NCR234977), which included a Qualitative Study, Causal Loop Analysis workshop and Village Health Worker Intervention Design. The VHW care model was then tested in the Phase 2 Feasibility study (GWU IRB # NCR235114) in 3 villages conducted over three months (November 2023-January 2024).
Specific aim of this study includes:
to assess the impact of a village health worker (VHW) care model in reducing cardiovascular disease (CVD) risk in rural Myanmar by conducting a cluster randomized trial in 13 villages surrounding 3 clinics.
Hypothesis: High proportions of villagers over 40 are screened for elevated CVD risk (>90%), attend a confirmatory visit (>85%), initiate a high proportion of evidence-based therapies (>75%), participate in at least one follow-up visit (>70%) and are adherent to therapy at three months (>50%).
to evaluate implementation of the VHW CVD program using the REAIM-PRISM framework.
Hypothesis: The VHW CVD intervention has broad reach, is acceptable, effective, is widely adopted, and perceived to be sustainable by community partners.
Hypothesis: The VHW CVD intervention is cost-effective, affordable, and sustainable.
Advantage of the study:
The VHW care model extends basic monitoring and treatment functions for chronic disease management to remote rural villages where physical terrain, high transportation cost and insecurity limit options for transportation to and from centralized clinic locations. Via VHWs, patient medication adherence, blood pressure, and blood glucose (when relevant) will be reported to treating clinicians (medics). Medics will be able to use this information to either schedule an in-person visit or to remotely refill or titrate medications.
4,904 studies on the registry are indexed under Cardiovascular Diseases; 919 are open to participants now.
This study's enrollment of 213 is above the median of 100 across 2,738 interventional studies indexed under Cardiovascular Diseases.
Browse Cardiovascular Diseases studies →This is the only study on the registry with Community Partners International as lead sponsor.
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Exclusion criteria
- Currently pregnant or within three months postpartum
7 villages are randomly selected and people (40 years and above) with increased cardiovascular disease risk receive VHW Care
Behavioral: Village Health Worker (VHW) Care Model
6 control villages randomly selected from 6 matched pairs and triplets of villages, and conduct a baseline and endline survey
VHW care model includes four components: (1) universal screening of all non-pregnant adults over 40 for elevated CVD risk (2) confirmatory visit to confirm diagnoses of hypertension, diabetes and elevated CVD risk (predicted 10-year risk \>10%) (3) monthly household visits by VHW; (4) an mHealth tool (tablet computer) to assist with determination of study eligibility and provide recommendations for initiation of medications according to local guidelines. VHW household visits include: health education on smoking cessation, healthy diet, physical activity and medication adherence; assessment of possible medication side effects, measurement of blood pressure and (when applicable) blood glucose; review monitoring results with the treating clinician household delivery of medications; and facilitate referral and transport to higher levels of care.
Change in medication adherence - self-reported MARS-5
Proportion of individuals adherent to evidence-based medications (taking the medication within the past 2 weeks, from self-report), AND a medication adherence report scale (MARS-5) adherence score of at least 16 out of 25. Requires taking at least one medication from each of the classes for which the individual is eligible: anti-hypertensive medication for individuals with hypertension, and statin for individuals with a history of ischemic heart disease, history of stroke, diabetes or 10-year CVD risk \>10%.
Time frame: 5 months
Change in medication adherence - self reported high
Proportion of individuals with high self reported adherence to evidence-based medications for which they are eligible. Requires taking at least one medication from each of the classes for which the individual is eligible (see primary outcome), AND a MARS-5 adherence scale of at least 20 out of 25. The MARS-5 adherence scale has a range from 5 to 25, with higher scores representing higher self-reported adherence.
Time frame: 5 months
Change in medication adherence - lenient
Proportion of individual taking at least one among any of the evidence-based medication classes s/he is eligible for (less strict definition medication adherence)
Time frame: 5 months
Change in population level adherence
Population level adherence, calculated as the ratio of the sum of the medication classes taken divided by the sum of eligible medication classes, among all individuals in the group. For example, if individual 1 is eligible for and takes one medication and if individual is eligible for two medications but takes only one, then population level adherence = (1+1) / (1+ 2) = 0.66.
Time frame: 5 months
Change in adherence to blood pressure medication
Respective proportions reporting 'moderate' or 'high' adherence to blood pressure medications using 'low' (5 to 15), 'moderate' (16 to 20) or 'high' (21-25) on the MARS-5 adherence scale. The MARS-5 adherence scale has a range from 5 to 25, with higher scores representing higher self-reported adherence.
Time frame: 5 months
Change in adherence to statin medication
Respective proportions reporting 'low', 'moderate' or 'high' adherence to blood pressure medications using 'low' (5 to 15), 'moderate' (16 to 20) or 'high' (21-25 on the MARS-5 adherence scale. The MARS-5 adherence scale has a range from 5 to 25, with higher scores representing higher self-reported adherence.
Time frame: 5 months
Change in mean MARS-5 adherence score
Among individuals eligible for either blood pressure or statin medication. The MARS-5 adherence scale has a range from 5 to 25, , with higher scores representing higher self-reported adherence.
Time frame: 5 months
Change in first and recurrent CVD event risk
Change in CVD event risk is assessed using a modified relative risk reduction tool that accurately quantifies longitudinal changes in cardiovascular disease risk.
Time frame: 5 months
Change in mean CVD risk predicted by World Health Organization CVD risk calculator
Change in mean CVD risk is the difference between the mean 10-year CVD risk of participants eligible for treatment at endline and the mean 10-year CVD risk of eligible individuals at baseline, as calculated using the WHO CVD risk equation. This method is known to inaccurately estimate change in CVD risk; it is reported for the sake of comparison to studies that (mis)use the WHO risk equation to define outcomes.
Time frame: 5 months
Change in relative Go Score
The relative GO score is defined as the proportion of benefit (relative CVD risk reduction) achieved, out of the maximum benefit possible from guideline directed therapy. The two therapies in the current study are blood pressure medications and statins. The GO Score has minimum value of zero and maximum value of one, with higher values representing a better outcome (greater proportion of possible benefit achieved). The relative GO Score is calculated using the ratio of relative risk reduction achieved divided by the relative risk reduction possible.
Time frame: 5 months
Change in absolute Go Score
The absolute GO score is defined as the proportion of absolute benefit (absolute CVD risk reduction) achieved, out of the maximum benefit possible from guideline directed therapy. The two therapies in the current study are blood pressure medications and statins. The GO Score has minimum value of zero and maximum value of one, with higher values representing a better outcome (greater proportion of possible benefit achieved). The absolute GO Score is calculated using the ratio of absolute risk reduction achieved to the absolute risk reduction possible.
Time frame: 5 months
Care cascade step 1: proportion aware of their diagnosis
Proportion of the number of participants aware of their diagnoses (hypertension, diabetes and elevated CVD risk) to adults over 40 years eligible for statins, anti-hypertensive treatment, or both statins and anti-hypertensives
Time frame: 5 months
Care cascade step 2: proportion linked to care
Proportion of participants linked to care (at least 1 clinic visit or VHW visit for CVD risk management) among adults over 40 years eligible for treatment
Time frame: 5 months
Care cascade step 3: proportion initiated on appropriate medications
Proportion of participants initiated on appropriate medications among adults over 40 years eligible for treatment.
Time frame: 5 months
Care cascade step 4: proportion taking appropriate medication
Proportion of participants who report taking appropriate medication in the past two weeks among adults over 40 years eligible for treatment
Time frame: 5 months
Care cascade step 5: proportion adherent to treatment
Proportion of participants who report taking appropriate medication in the past two weeks AND who report adherence to treatment, where adherence is defined as 16-25 on the MARS-5 adherence scale. The MARS-5 adherence scale has a range from 5 to 25, , with higher scores representing higher self-reported adherence.
Time frame: 5 months
Hypertension Care cascade step 1: proportion aware of their diagnosis
Proportion of the number of participants aware of their diagnoses (hypertension, diabetes and elevated CVD risk) to adults over 40 years eligible for statins, anti-hypertensive treatment, or both statins and anti-hypertensives
Time frame: 5 months
Hypertension Care cascade step 2: proportion linked to care
Proportion of participants linked to care (at least 1 clinic visit or VHW visit for CVD risk management) among adults over 40 years eligible for treatment
Time frame: 5 months
Hypertension Care cascade step 3: proportion initiated on appropriate medications
Proportion of participants initiated on appropriate medications among adults over 40 years eligible for treatment.
Time frame: 5 months
Hypertension Care cascade step 4: proportion taking appropriate medication
Proportion of participants who report taking appropriate medication in the past two weeks among adults over 40 years eligible for treatment
Time frame: 5 months
Hypertension Care cascade step 5: proportion adherent to treatment
Proportion of participants who report taking appropriate medication in the past two weeks AND who report adherence to treatment, where adherence is defined as 16-25 on the MARS-5 adherence scale. The MARS-5 adherence scale has a range from 5 to 25, , with higher scores representing higher self-reported adherence.
Time frame: 5 months
Hypertension Care cascade step 6: proportion with systolic blood pressure below 140mmHg
Proportion of participants with systolic blood pressure below 140mmHg among adults over 40 years with hypertension
Time frame: 5 months
Hypertension Care cascade step 7: proportion with systolic blood pressure below 130mmHg
Proportion of participants with systolic blood pressure below 130mmHg among adults over 40 years with hypertension
Time frame: 5 months
Hypertension Care cascade step 8: proportion with systolic blood pressure below 120mmHg
Proportion of participants with systolic blood pressure below 120mmHg among adults over 40 years with hypertension
Time frame: 5 months
Statin care cascade step 1: proportion linked to care
Proportion of participants linked to care (at least 1 clinic visit or VHW visit for CVD risk management) among adults over 40 years eligible for statin treatment
Time frame: 5 months
Statin care cascade step 2: proportion initiated on appropriate medications
Proportion of participants initiated on appropriate medications among adults over 40 years eligible for treatment.
Time frame: 5 months
Statin care cascade step 3: proportion taking appropriate medication
Proportion of participants who report taking appropriate medication in the past two weeks among adults over 40 years eligible for treatment
Time frame: 5 months
Statin care cascade step 4: proportion adherent to statin treatment
Proportion of participants who report taking appropriate medication in the past two weeks AND who report adherence to treatment, where adherence is defined as 16-25 on the MARS-5 adherence scale. The MARS-5 adherence scale has a range from 5 to 25, , with higher scores representing higher self-reported adherence.
Time frame: 5 months
Change in mean systolic blood pressure in the hypertensive population
Changes in blood pressure is the difference between the mean systolic blood pressure at baseline and the mean systolic blood pressure at endline, among individuals with likely hypertension, defined as taking anti-hypertensive treatment.
Time frame: 5 months
Change in current smoking prevalence
Current smoking is assessed by an affirmative answer to the question "In the past two weeks have participant smoked any tobacco products, such as cigarettes, cigars or pipes?", asked on individuals with likely eligible for blood pressure medication or statin treatment. Smoking prevalence is defined as the proportion of current smokers among all adults 40 years or older.
Time frame: 5 months
Mean change in systolic blood pressure among individuals with hypertension who have repeated measures
Changes in systolic blood pressure is the (paired) mean difference in systolic blood pressure from baseline to endline change , among individuals with likely hypertension who have measurements at baseline and endline. In intervention villages individuals with repeated measures were assessed during village screening at baseline and the endline assessments; in control villages individuals with repeated measures represent approximately one-quarter of individuals who expected to participate in both baseline and endline household surveys (both surveys target half of all households, hence the probability of being selected at both baseline and endline is approximately 0.25).
Time frame: 5 months
Smoking cessation (quit) rate among smokers with repeated measures
Current smoking is assessed by an affirmative answer to the question "In the past two weeks have participant smoked any tobacco products, such as cigarettes, cigars or pipes?", asked of individuals eligible for anti-hypertension or statin treatment. Smoking cessation (quite rate) is defined as the proportion of current smokers at baseline who do not report current smoking at endline. In intervention villages individuals with repeated measures were assessed during village screening at baseline and the endline assessments; in control villages individuals with repeated measures represent approximately one-quarter of individuals who expected to participate in both baseline and endline household surveys (both surveys target half of all households, hence the probability of being selected at both baseline and endline is approximately 0.25).
Time frame: 5 months
Change in medication adherence among individuals with repeated measures
Proportion of individuals adherent to evidence-based medications (taking the medication within the past 2 weeks, from self-report), AND a medication adherence report scale (MARS-5) adherence score of at least 16 out of 25. Requires taking at least one medication from each of the classes for which the individual is eligible: anti-hypertensive medication for individuals with hypertension, and statin for individuals with a history of ischemic heart disease, history of stroke, diabetes or 10-year CVD risk \>10%. In intervention villages individuals with repeated measures were assessed during village screening at baseline and the endline assessments; in control villages individuals with repeated measures represent approximately one-quarter of individuals who expected to participate in both baseline and endline household surveys (both surveys target half of all households, hence the probability of being selected at both baseline and endline is approximately 0.25).
Time frame: 5 months
Changes in GO Score among individuals with repeated measures
Changes in GO Score is the difference between observed changes in blood pressure and smoking cessation among individuals at endline AND observed changes in blood pressure and smoking cessation among individuals at baseline. The GO Score has minimum value of zero and maximum value of one, with higher values representing a better outcome (greater proportion of possible benefit achieved).
Time frame: 5 months
Effect modification by presence of a disability
Disability is defined as either "a lot of difficulty" or "cannot do at all" in relation to at least one of 8 disability function items from the Washington Group - Extended Set on Function (WG-ES)
Time frame: 5 months
Effect modification by 10-year (predicted) CVD risk
Using 10-year (predicted) CVD risk
Time frame: 5 months
Effect modification by Sex
Stratified by male and female
Time frame: 5 months
Effect modification by Age
Stratified by age groups (40-49 years, 50-59, 60-69, 70+)
Time frame: 5 months
Effect modification by household wealth
Using Myanmar wealth quintiles defined by Equity tool
Time frame: 5 months
Effect modification by respondent educational attainment
Using Educational attainment
Time frame: 5 months
Effect modification by income
Using level of income
Time frame: 5 months
Effect modification by residential status in the village
Residential status is defined as arrival before/after initial screening (dichotomous)
Time frame: 5 months
Multidimensional index of vulnerability
The multidimensional index of vulnerability will be calculated as a multivariate propensity score of the primary dichotomous outcome, using the predicted probability from a logistic regression model that includes multiple axes of disadvantage as predictors including household wealth, educational attainment, income, women's empowerment and distance from a health facility. The index has a minimum value of 0 and maximum value of 1. Increasing values represent higher vulnerability.
Time frame: 5 months
Changes in relative inequities in primary and secondary outcomes: the relative concentration index
Relative health inequities will be summarized on the relative scale using the relative concentration index, a summary health equity metric developed by the World Bank. The relative concentration index has a range from zero to 1 (though the range for dichotomous outcomes is 'bounded', with a lower maximum value that varies as a function of the proportion of the outcome.
Time frame: 5 months
Changes in absolute inequities in primary and secondary outcomes: the absolute concentration index
Absolute health inequities will be summarized on the absolute scale using the absolute concentration index, a summary health equity metric developed by the World Bank, and equal to the mean value in the population multiplied by the relative concentration index (see Wagstaff et al 2002).
Time frame: 5 months
Changes in equity-weighted primary and secondary outcomes: the achievement index
We will calculate the achievement index, an equity-weighted health outcome metric developed by the World Bank, and equal to the mean value in the population multiplied by (1 minus the relative concentration index); (see Wagstaff et al 2002).
Time frame: 5 months
Linkage to care cascade 1: proportion of adults screened for CVD risk factors
Proportion of population \>40 years old who complete screening questionnaire, in intervention villages
Time frame: 5 months
Linkage to care cascade 2: proportion of adults who complete a confirmatory visit
Proportion of population \>40 years old who complete confirmatory visit, among adults eligible for a confirmatory visit
Time frame: 5 months
Linkage to care cascade 3: proportion of adults eligible for the longitudinal study who attended at least one VHW visit
Proportion of adults eligible for the longitudinal study who attended at least one VHW visit
Time frame: 5 months
Linkage to care cascade 4: proportion retained in care at the end of the study
Retained in care is defined as not withdrawn from the study participated in a VHW visit in the previous 60 days
Time frame: 5 months
Mean number (n, %) of VHW visits completed
Mean number (n, %) of VHW visits completed among eligible population
Time frame: 5 months
Mean number (n, %) of medic visits per participant
Mean number (n, %) of medic visits per participant among eligible population
Time frame: 5 months
Refused participation, among eligible individuals (n, %)
Number (n, %) of individuals among eligible population who refused to participate in the study
Time frame: 5 months
Withdrew from study
Number (n, %) of individuals among eligible population who withdrew from study
Time frame: 5 months
Deceased (n, %)
Number (n,%) of individuals among eligible population who died during the duration of the study
Time frame: 5 months
Referrals for acute symptoms or other complication
Number (n, %) of individuals among eligible population who received referrals for acute symptoms or other complication
Time frame: 5 months
Proportion of visits with adequate quality clinical decision-making
Proportion of visits with adequate quality clinical decision-making from a logbook chart review
Time frame: 5 months
Plan to share: No
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