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

NCT06819839 | Completed DMC

• 1 other identifier: NCR245957
• Study Type: interventional
• Target: 213
• Locations: 1 country
• Sites: 1

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?

Conditions

Cardiovascular Diseases; Hypertension; Diabetes

Keywords

Cardiovascular disease (CVD); Village health worker; Eastern Myanmar; Hypertension; Diabetes; Care delivery model

Outcome Measures

Primary Outcomes (1)

• Change in medication adherence - self-reported MARS-5

  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%.

  5 months

Secondary Outcomes (56)

• Change in medication adherence - self reported high

  5 months

• Change in medication adherence - lenient

  5 months

• Change in population level adherence

  5 months

• Change in adherence to blood pressure medication

  5 months

• Change in adherence to statin medication

  5 months

Study Arms (2)

Village Health Worker (VHW) Care Model

EXPERIMENTAL

7 villages are randomly selected and people (40 years and above) with increased cardiovascular disease risk receive VHW Care

Behavioral: Village Health Worker (VHW) Care Model

Standard Community Care

NO INTERVENTION

6 control villages randomly selected from 6 matched pairs and triplets of villages, and conduct a baseline and endline survey

Interventions

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.

Village Health Worker (VHW) Care Model

Eligibility Criteria

• Age: 40 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \- Currently pregnant or within three months postpartum

Sponsors & Collaborators

• Community Partners International: lead
• Khon Kaen University: collaborator
• George Washington University: collaborator
• University of California, San Diego: collaborator

Study Sites (1)

Community Partners International

Hpa-An, Kayin State, Burma

Location

Related Publications (27)

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  BACKGROUND

MeSH Terms

Conditions

Cardiovascular Diseases; Hypertension; Diabetes Mellitus

Interventions

Community Health Workers

Condition Hierarchy (Ancestors)

Vascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Allied Health Personnel; Health Personnel; Health Care Facilities Workforce and Services

Study Officials

• Adam Richards

  George Washington University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Cluster Randomized Controlled Trial in 13 villages

Study Record Dates

• First Submitted: January 25, 2025
• First Posted: February 11, 2025
• Study Start: October 27, 2024
• Primary Completion: April 30, 2025
• Study Completion: June 30, 2025
• Last Updated: July 31, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

BU (1)