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

NCT06819839 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 213

Last updated 2025-07-31

No results posted yet for this study

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?

Conditions

Interventions

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.

Sponsors & Collaborators

  • Khon Kaen University

    collaborator OTHER
  • George Washington University

    collaborator OTHER
  • University of California, San Diego

    collaborator OTHER
  • Community Partners International

    lead OTHER

Principal Investigators

  • Adam Richards · George Washington University

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-27
Primary Completion
2025-04-30
Completion
2025-06-30

Countries

  • Burma

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06819839 on ClinicalTrials.gov