NCT06819839

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

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)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 213 (actual)
• Sponsor: Community Partners International · Academic / Other
• Sex: All
• Age: 40 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cardiovascular Diseases
• Hypertension
• Diabetes

Interventions

Type	Name	Description
BEHAVIORAL	Village Health Worker (VHW) Care Model	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.

Timeline

• Start date: 2024-10-27
• Primary completion: 2025-04-30
• Completion: 2025-06-30
• First posted: 2025-02-11
• Last updated: 2025-07-31

Locations

1 site across 1 country: Burma