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Female Community Health Volunteers Led Hypertension Prevention and Control in Nepal

NCT06163859 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 520

Last updated 2026-01-13

No results posted yet for this study

Summary

Brief Summary Hypertension is a major public health problem in Nepal, with substantial gaps in awareness, treatment, and control, particularly in rural and semi-urban settings. Nepal has adopted the WHO Package of Essential Non-Communicable Diseases (PEN) to strengthen facility-based hypertension care; however, persistent community- and system-level barriers limit its effectiveness.

This study evaluates a Female Community Health Volunteer (FCHV)-led, community-based hypertension prevention and control intervention in Namobuddha Municipality, Kavrepalanchowk District, Nepal. The study uses a hybrid type II effectiveness-implementation cluster randomized controlled trial design to assess both implementation outcomes and clinical effectiveness. Twelve public primary healthcare facilities are randomized (1:1) to intervention or routine care. Implementation outcomes are assessed using the RE-AIM framework (Reach, Effectiveness, Adoption, and Implementation). The primary effectiveness outcome is change in mean systolic blood pressure at three months. Secondary outcomes include diastolic blood pressure, hypertension control status, hypertension knowledge, dietary behavior, medication adherence, and body mass index. The intervention mobilizes trained FCHVs to deliver group-based blood pressure monitoring, structured health education, lifestyle counseling, medication adherence support, and referral linkages to primary healthcare facilities.

Conditions

Interventions

BEHAVIORAL

Intervention Group

FCHVs will undergo a 3-day training program on hypertension management, including screening, counseling, medication adherence, self-care, and referrals. FCHVs will form groups for individuals with hypertension and hold monthly meetings to discuss control strategies, review BP logs, and promote healthcare visits, including family involvement. They will also maintain regular communication with healthcare facility in-charges to ensure effective collaboration in the 'Hypertension Care Cascade Model'.

Sponsors & Collaborators

  • World Health Organization

    collaborator OTHER

  • Institute for Implementation Science and Health

    collaborator UNKNOWN

  • Kathmandu University School of Medical Sciences

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
30 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-01-05
Primary Completion
2025-03-16
Completion
2025-05-01

Countries

  • Nepal

Study Locations

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Diseases
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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 NCT06163859 on ClinicalTrials.gov