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

Not Applicable

Active, not recruiting

• Conditions: Cardiovascular Diseases; Hypertension; Diabetes

• Registration Number: NCT06819839
• Lead Sponsor: Community Partners International

Brief Summary

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?

Detailed Description

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:

1. 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%).

2. 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.

3. 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.

Study Timeline

• Study Start: 2024-10-27
• Status Verified: 2024-12
• Study First Submitted: 2025-01-25
• Study First Submitted QC: 2025-02-05
• Last Update Submitted: 2025-02-05
• Study First Posted: 2025-02-11
• Last Update Posted: 2025-02-11
• Primary Completion: 2025-04-30
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 213

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change in medication adherence - self-reported MARS-5	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 Outcome Measures

Name	Time	Method
Change in first and recurrent CVD event risk	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.
Change in medication adherence - lenient	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)
Change in medication adherence - self reported high	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.
Change in adherence to blood pressure medication	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.
Change in mean MARS-5 adherence score	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.
Care cascade step 2: proportion linked to care	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
Care cascade step 3: proportion initiated on appropriate medications	5 months	Proportion of participants initiated on appropriate medications among adults over 40 years eligible for treatment.
Care cascade step 4: proportion taking appropriate medication	5 months	Proportion of participants who report taking appropriate medication in the past two weeks among adults over 40 years eligible for treatment
Hypertension Care cascade step 6: proportion with systolic blood pressure below 140mmHg	5 months	Proportion of participants with systolic blood pressure below 140mmHg among adults over 40 years with hypertension
Hypertension Care cascade step 8: proportion with systolic blood pressure below 120mmHg	5 months	Proportion of participants with systolic blood pressure below 120mmHg among adults over 40 years with hypertension
Change in population level adherence	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.
Change in adherence to statin medication	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.
Change in mean CVD risk predicted by World Health Organization CVD risk calculator	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.
Care cascade step 1: proportion aware of their diagnosis	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
Change in relative Go Score	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.
Change in absolute Go Score	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.
Care cascade step 5: proportion adherent to treatment	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.
Hypertension Care cascade step 2: proportion linked to care	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
Hypertension Care cascade step 4: proportion taking appropriate medication	5 months	Proportion of participants who report taking appropriate medication in the past two weeks among adults over 40 years eligible for treatment
Hypertension Care cascade step 1: proportion aware of their diagnosis	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
Hypertension Care cascade step 3: proportion initiated on appropriate medications	5 months	Proportion of participants initiated on appropriate medications among adults over 40 years eligible for treatment.
Change in current smoking prevalence	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.
Hypertension Care cascade step 7: proportion with systolic blood pressure below 130mmHg	5 months	Proportion of participants with systolic blood pressure below 130mmHg among adults over 40 years with hypertension
Statin care cascade step 1: proportion linked to care	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
Statin care cascade step 3: proportion taking appropriate medication	5 months	Proportion of participants who report taking appropriate medication in the past two weeks among adults over 40 years eligible for treatment
Hypertension Care cascade step 5: proportion adherent to treatment	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.
Statin care cascade step 2: proportion initiated on appropriate medications	5 months	Proportion of participants initiated on appropriate medications among adults over 40 years eligible for treatment.
Statin care cascade step 4: proportion adherent to statin treatment	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.
Change in mean systolic blood pressure in the hypertensive population	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.
Mean change in systolic blood pressure among individuals with hypertension who have repeated measures	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).
Smoking cessation (quit) rate among smokers with repeated measures	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).
Linkage to care cascade 1: proportion of adults screened for CVD risk factors	5 months	Proportion of population \>40 years old who complete screening questionnaire, in intervention villages
Change in medication adherence among individuals with repeated measures	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).
Changes in GO Score among individuals with repeated measures	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).
Effect modification by presence of a disability	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)
Effect modification by 10-year (predicted) CVD risk	5 months	Using 10-year (predicted) CVD risk
Effect modification by Sex	5 months	Stratified by male and female
Effect modification by household wealth	5 months	Using Myanmar wealth quintiles defined by Equity tool
Effect modification by Age	5 months	Stratified by age groups (40-49 years, 50-59, 60-69, 70+)
Multidimensional index of vulnerability	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.
Effect modification by respondent educational attainment	5 months	Using Educational attainment
Effect modification by income	5 months	Using level of income
Effect modification by residential status in the village	5 months	Residential status is defined as arrival before/after initial screening (dichotomous)
Linkage to care cascade 2: proportion of adults who complete a confirmatory visit	5 months	Proportion of population \>40 years old who complete confirmatory visit, among adults eligible for a confirmatory visit
Linkage to care cascade 3: proportion of adults eligible for the longitudinal study who attended at least one VHW visit	5 months	Proportion of adults eligible for the longitudinal study who attended at least one VHW visit
Changes in relative inequities in primary and secondary outcomes: the relative concentration index	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.
Changes in absolute inequities in primary and secondary outcomes: the absolute concentration index	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).
Changes in equity-weighted primary and secondary outcomes: the achievement index	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).
Linkage to care cascade 4: proportion retained in care at the end of the study	5 months	Retained in care is defined as not withdrawn from the study participated in a VHW visit in the previous 60 days
Mean number (n, %) of VHW visits completed	5 months	Mean number (n, %) of VHW visits completed among eligible population
Mean number (n, %) of medic visits per participant	5 months	Mean number (n, %) of medic visits per participant among eligible population
Refused participation, among eligible individuals (n, %)	5 months	Number (n, %) of individuals among eligible population who refused to participate in the study
Withdrew from study	5 months	Number (n, %) of individuals among eligible population who withdrew from study
Deceased (n, %)	5 months	Number (n,%) of individuals among eligible population who died during the duration of the study
Referrals for acute symptoms or other complication	5 months	Number (n, %) of individuals among eligible population who received referrals for acute symptoms or other complication
Proportion of visits with adequate quality clinical decision-making	5 months	Proportion of visits with adequate quality clinical decision-making from a logbook chart review

Trial Locations

Locations (1)

Community Partners International; 🇲🇲 Hpa An, Karen, Myanmar