CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 520 enrolled
Drug / intervention
Intervention Groupbehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT06163859
NCT06163859N/ACompleted

Female Community Health Volunteers Led Hypertension Prevention and Control in Nepal: An Implementation Study

Kathmandu University School of Medical Sciences·interventional·Posted Dec 11, 2023·Updated Jan 13, 2026

In Brief

A clinical study evaluating Intervention Group for Hypertension. Completed, enrolled 520 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHypertension
CountriesNepal

Timeline

N/ACompletedFinished
202420252026
First PostedDec 11, 2023
Enrollment StartJan 5, 2024
Primary CompletionMar 16, 2025
Study CompletionMay 1, 2025
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 2.6 years ago

Interventions

Intervention Groupbehavioral

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'.