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Completed

NCT Number: NCT06819839

Community-led Strategy to Reduce Cardiovascular Disease Risk Among Conflict-affected Populations

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?

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Key information

Age range

40 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Community Partners International

Hpa-An, Kayin State, Burma

About this study

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.

  • to establish the time and cost required to carry out VHW care model activities as well as their impact on the care cascade for CVD risk, from screening to linkage to care, initiation of therapy and retention in care.

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Aged 40 years or older
  • Current resident of study villages
  • No previous history of screening during the feasibility study a year ago
  • At least one CVD risk factor

Exclusion criteria

  • Currently pregnant or within three months postpartum

Treatment and study plan

Village Health Worker (VHW) Care Model

Behavioral

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.

Primary outcomes

  1. Change in medication adherence - self-reported MARS-5

    Time frame: 5 months

    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%.

Secondary outcomes

  1. Change in medication adherence - self reported high

    Time frame: 5 months

    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.

  2. Change in medication adherence - lenient

    Time frame: 5 months

    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)

  3. Change in population level adherence

    Time frame: 5 months

    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.

  4. Change in adherence to blood pressure medication

    Time frame: 5 months

    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.

  5. Change in adherence to statin medication

    Time frame: 5 months

    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.

  6. Change in mean MARS-5 adherence score

    Time frame: 5 months

    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.

  7. Change in first and recurrent CVD event risk

    Time frame: 5 months

    Change in CVD event risk is assessed using a modified relative risk reduction tool that accurately quantifies longitudinal changes in cardiovascular disease risk.

  8. Change in mean CVD risk predicted by World Health Organization CVD risk calculator

    Time frame: 5 months

    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.

  9. Change in relative Go Score

    Time frame: 5 months

    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.

  10. Change in absolute Go Score

    Time frame: 5 months

    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.

  11. Care cascade step 1: proportion aware of their diagnosis

    Time frame: 5 months

    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

  12. Care cascade step 2: proportion linked to care

    Time frame: 5 months

    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

  13. Care cascade step 3: proportion initiated on appropriate medications

    Time frame: 5 months

    Proportion of participants initiated on appropriate medications among adults over 40 years eligible for treatment.

  14. Care cascade step 4: proportion taking appropriate medication

    Time frame: 5 months

    Proportion of participants who report taking appropriate medication in the past two weeks among adults over 40 years eligible for treatment

  15. Care cascade step 5: proportion adherent to treatment

    Time frame: 5 months

    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.

  16. Hypertension Care cascade step 1: proportion aware of their diagnosis

    Time frame: 5 months

    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

  17. Hypertension Care cascade step 2: proportion linked to care

    Time frame: 5 months

    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

  18. Hypertension Care cascade step 3: proportion initiated on appropriate medications

    Time frame: 5 months

    Proportion of participants initiated on appropriate medications among adults over 40 years eligible for treatment.

  19. Hypertension Care cascade step 4: proportion taking appropriate medication

    Time frame: 5 months

    Proportion of participants who report taking appropriate medication in the past two weeks among adults over 40 years eligible for treatment

  20. Hypertension Care cascade step 5: proportion adherent to treatment

    Time frame: 5 months

    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.

  21. Hypertension Care cascade step 6: proportion with systolic blood pressure below 140mmHg

    Time frame: 5 months

    Proportion of participants with systolic blood pressure below 140mmHg among adults over 40 years with hypertension

  22. Hypertension Care cascade step 7: proportion with systolic blood pressure below 130mmHg

    Time frame: 5 months

    Proportion of participants with systolic blood pressure below 130mmHg among adults over 40 years with hypertension

  23. Hypertension Care cascade step 8: proportion with systolic blood pressure below 120mmHg

    Time frame: 5 months

    Proportion of participants with systolic blood pressure below 120mmHg among adults over 40 years with hypertension

  24. Statin care cascade step 1: proportion linked to care

    Time frame: 5 months

    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

  25. Statin care cascade step 2: proportion initiated on appropriate medications

    Time frame: 5 months

    Proportion of participants initiated on appropriate medications among adults over 40 years eligible for treatment.

  26. Statin care cascade step 3: proportion taking appropriate medication

    Time frame: 5 months

    Proportion of participants who report taking appropriate medication in the past two weeks among adults over 40 years eligible for treatment

  27. Statin care cascade step 4: proportion adherent to statin treatment

    Time frame: 5 months

    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.

  28. Change in mean systolic blood pressure in the hypertensive population

    Time frame: 5 months

    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.

  29. Change in current smoking prevalence

    Time frame: 5 months

    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.

  30. Mean change in systolic blood pressure among individuals with hypertension who have repeated measures

    Time frame: 5 months

    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).

  31. Smoking cessation (quit) rate among smokers with repeated measures

    Time frame: 5 months

    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).

  32. Change in medication adherence among individuals with repeated measures

    Time frame: 5 months

    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).

  33. Changes in GO Score among individuals with repeated measures

    Time frame: 5 months

    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).

  34. Effect modification by presence of a disability

    Time frame: 5 months

    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)

  35. Effect modification by 10-year (predicted) CVD risk

    Time frame: 5 months

    Using 10-year (predicted) CVD risk

  36. Effect modification by Sex

    Time frame: 5 months

    Stratified by male and female

  37. Effect modification by Age

    Time frame: 5 months

    Stratified by age groups (40-49 years, 50-59, 60-69, 70+)

  38. Effect modification by household wealth

    Time frame: 5 months

    Using Myanmar wealth quintiles defined by Equity tool

  39. Effect modification by respondent educational attainment

    Time frame: 5 months

    Using Educational attainment

  40. Effect modification by income

    Time frame: 5 months

    Using level of income

  41. Effect modification by residential status in the village

    Time frame: 5 months

    Residential status is defined as arrival before/after initial screening (dichotomous)

  42. Multidimensional index of vulnerability

    Time frame: 5 months

    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.

  43. Changes in relative inequities in primary and secondary outcomes: the relative concentration index

    Time frame: 5 months

    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.

  44. Changes in absolute inequities in primary and secondary outcomes: the absolute concentration index

    Time frame: 5 months

    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).

  45. Changes in equity-weighted primary and secondary outcomes: the achievement index

    Time frame: 5 months

    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).

  46. Linkage to care cascade 1: proportion of adults screened for CVD risk factors

    Time frame: 5 months

    Proportion of population >40 years old who complete screening questionnaire, in intervention villages

  47. Linkage to care cascade 2: proportion of adults who complete a confirmatory visit

    Time frame: 5 months

    Proportion of population >40 years old who complete confirmatory visit, among adults eligible for a confirmatory visit

  48. Linkage to care cascade 3: proportion of adults eligible for the longitudinal study who attended at least one VHW visit

    Time frame: 5 months

    Proportion of adults eligible for the longitudinal study who attended at least one VHW visit

  49. Linkage to care cascade 4: proportion retained in care at the end of the study

    Time frame: 5 months

    Retained in care is defined as not withdrawn from the study participated in a VHW visit in the previous 60 days

  50. Mean number (n, %) of VHW visits completed

    Time frame: 5 months

    Mean number (n, %) of VHW visits completed among eligible population

  51. Mean number (n, %) of medic visits per participant

    Time frame: 5 months

    Mean number (n, %) of medic visits per participant among eligible population

  52. Refused participation, among eligible individuals (n, %)

    Time frame: 5 months

    Number (n, %) of individuals among eligible population who refused to participate in the study

  53. Withdrew from study

    Time frame: 5 months

    Number (n, %) of individuals among eligible population who withdrew from study

  54. Deceased (n, %)

    Time frame: 5 months

    Number (n,%) of individuals among eligible population who died during the duration of the study

  55. Referrals for acute symptoms or other complication

    Time frame: 5 months

    Number (n, %) of individuals among eligible population who received referrals for acute symptoms or other complication

  56. Proportion of visits with adequate quality clinical decision-making

    Time frame: 5 months

    Proportion of visits with adequate quality clinical decision-making from a logbook chart review

Sponsors and collaborators

Lead sponsor

Community Partners International

Other

Collaborators

  • George Washington University
  • Khon Kaen University
  • University of California, San Diego

Registry information

Official study title

Impact of a Community Health Worker Care Model to Reduce Cardiovascular Disease Risk Among Conflict-affected Populations in Eastern Myanmar: a Cluster Randomized Controlled Trial (cRCT)

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 11, 2025
Registry last updated
Jul 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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