Clinical trial NCT06819839: Community-led Strategy to Reduce Cardiovascular Disease Risk Among Conflict-affected Populations
Official 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)
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Cardiovascular Diseases
Hypertension
Diabetes
Keywords: Cardiovascular disease (CVD)
Village health worker
Eastern Myanmar
Hypertension
Diabetes
Care delivery model
Lead sponsor: Community Partners International
Sponsor class: OTHER
Collaborators: name: Khon Kaen University
name: George Washington University
name: University of California, San Diego
First posted: 2025-02-11
Enrollment: 213
Sex: ALL
Minimum age (years): 40
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster Randomized Controlled Trial in 13 villages
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in medication adherence - self-reported MARS-5
timeFrame: 5 months
Secondary outcomes:
measure: Change in medication adherence - self reported high
timeFrame: 5 months
measure: Change in medication adherence - lenient
timeFrame: 5 months
measure: Change in population level adherence
timeFrame: 5 months
measure: Change in adherence to blood pressure medication
timeFrame: 5 months
measure: Change in adherence to statin medication
timeFrame: 5 months
measure: Change in mean MARS-5 adherence score
timeFrame: 5 months
measure: Change in first and recurrent CVD event risk
timeFrame: 5 months
measure: Change in mean CVD risk predicted by World Health Organization CVD risk calculator
timeFrame: 5 months
measure: Change in relative Go Score
timeFrame: 5 months
measure: Change in absolute Go Score
timeFrame: 5 months
measure: Care cascade step 1: proportion aware of their diagnosis
timeFrame: 5 months
measure: Care cascade step 2: proportion linked to care
timeFrame: 5 months
measure: Care cascade step 3: proportion initiated on appropriate medications
timeFrame: 5 months
measure: Care cascade step 4: proportion taking appropriate medication
timeFrame: 5 months
measure: Care cascade step 5: proportion adherent to treatment
timeFrame: 5 months
measure: Hypertension Care cascade step 1: proportion aware of their diagnosis
timeFrame: 5 months
measure: Hypertension Care cascade step 2: proportion linked to care
timeFrame: 5 months
measure: Hypertension Care cascade step 3: proportion initiated on appropriate medications
timeFrame: 5 months
measure: Hypertension Care cascade step 4: proportion taking appropriate medication
timeFrame: 5 months
measure: Hypertension Care cascade step 5: proportion adherent to treatment
timeFrame: 5 months
measure: Hypertension Care cascade step 6: proportion with systolic blood pressure below 140mmHg
timeFrame: 5 months
measure: Hypertension Care cascade step 7: proportion with systolic blood pressure below 130mmHg
timeFrame: 5 months
measure: Hypertension Care cascade step 8: proportion with systolic blood pressure below 120mmHg
timeFrame: 5 months
measure: Statin care cascade step 1: proportion linked to care
timeFrame: 5 months
measure: Statin care cascade step 2: proportion initiated on appropriate medications
timeFrame: 5 months
measure: Statin care cascade step 3: proportion taking appropriate medication
timeFrame: 5 months
measure: Statin care cascade step 4: proportion adherent to statin treatment
timeFrame: 5 months
measure: Change in mean systolic blood pressure in the hypertensive population
timeFrame: 5 months
measure: Change in current smoking prevalence
timeFrame: 5 months
measure: Mean change in systolic blood pressure among individuals with hypertension who have repeated measures
timeFrame: 5 months
measure: Smoking cessation (quit) rate among smokers with repeated measures
timeFrame: 5 months
measure: Change in medication adherence among individuals with repeated measures
timeFrame: 5 months
measure: Changes in GO Score among individuals with repeated measures
timeFrame: 5 months
measure: Effect modification by presence of a disability
timeFrame: 5 months
measure: Effect modification by 10-year (predicted) CVD risk
timeFrame: 5 months
measure: Effect modification by Sex
timeFrame: 5 months
measure: Effect modification by Age
timeFrame: 5 months
measure: Effect modification by household wealth
timeFrame: 5 months
measure: Effect modification by respondent educational attainment
timeFrame: 5 months
measure: Effect modification by income
timeFrame: 5 months
measure: Effect modification by residential status in the village
timeFrame: 5 months
measure: Multidimensional index of vulnerability
timeFrame: 5 months
measure: Changes in relative inequities in primary and secondary outcomes: the relative concentration index
timeFrame: 5 months
measure: Changes in absolute inequities in primary and secondary outcomes: the absolute concentration index
timeFrame: 5 months
measure: Changes in equity-weighted primary and secondary outcomes: the achievement index
timeFrame: 5 months
measure: Linkage to care cascade 1: proportion of adults screened for CVD risk factors
timeFrame: 5 months
measure: Linkage to care cascade 2: proportion of adults who complete a confirmatory visit
timeFrame: 5 months
measure: Linkage to care cascade 3: proportion of adults eligible for the longitudinal study who attended at least one VHW visit
timeFrame: 5 months
measure: Linkage to care cascade 4: proportion retained in care at the end of the study
timeFrame: 5 months
measure: Mean number (n, %) of VHW visits completed
timeFrame: 5 months
measure: Mean number (n, %) of medic visits per participant
timeFrame: 5 months
measure: Refused participation, among eligible individuals (n, %)
timeFrame: 5 months
measure: Withdrew from study
timeFrame: 5 months
measure: Deceased (n, %)
timeFrame: 5 months
measure: Referrals for acute symptoms or other complication
timeFrame: 5 months
measure: Proportion of visits with adequate quality clinical decision-making
timeFrame: 5 months
Other outcomes:
Locations:
city: Hpa An
country: Burma
facility: Community Partners International
state: Karen
Study officials:
affiliation: George Washington University
name: Adam Richards
role: PRINCIPAL_INVESTIGATOR
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