Female Community Health Volunteers Led Hypertension Prevention and Control in Nepal

NCT06163859 | Completed

• 1 other identifier: 459
• Study Type: interventional
• Target: 520
• Locations: 1 country
• Sites: 1

Brief 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

Hypertension

Keywords

Community Health Workers; Hypertension Control; Hypertension Prevention; Implementation Study

Outcome Measures

Primary Outcomes (4)

• Reach

  The proportion of the target population that participates in the intervention. Indicators: Proportion of individuals screened during one-day hypertension screening camps in each health facilities by FCHVs.( denomiator will be determined using national prevalence of hypertension). Data Source: Patient records maintained by FCHV, attendance sheets from FCHV-HTN group meetings. Demographic distribution (age, gender, etc.) of the individuals screened.

  3 months

• Adoption

  Adoption is defined as the proportion of eligible health facilities that agreed to participate in the study. Participation will be confirmed through signed minutes from meetings between the municipal health coordinator and facility representatives, indicating formal approval to implement the program.

  3 months

• Implementation

  The extent to which the FCHV-led intervention is delivered as intended. Indicators: Number of FCHVs conducting complete (3 months) FCHV-HTN meetings, Documentation and follow-up of participants' blood pressure logs by FCHVs, duration of sessions conducted, number of sessions conducted. Data source: Forms sent by FCHV at health facilities (compiled at Health facilities), logs maintained by FCHVs

  3 months

• Mean systolic blood pressure (BP) (mmHg)

  The net change in mean systolic BP between intervention and control

  3 months

Secondary Outcomes (5)

• Mean diastolic BP (mmHg)

  3 months

• Physical activity

  3 months

• Fruits and vegetables intake

  3 months

• Medication adherence

  3 months

• Proportion controlling BP (<140/90 mmHg)

  3 months

Study Arms (2)

Intervention Group

EXPERIMENTAL

Female Community Health Volunteers (FHPC) implementation strategy

Behavioral: Intervention Group

Control Arm

NO INTERVENTION

Routine hypertension care

Interventions

Intervention Group BEHAVIORAL

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'.

Intervention Group

Eligibility Criteria

• Age: 30 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years old
• have a high blood pressure of 130/80 mmHg or under hypertension medication
• are able to provide informed consent.

You may not qualify if:

• severe illness requiring bed rest, and
• pregnant women, due to their special health needs.

Sponsors & Collaborators

• Institute for Implementation Science and Health: collaborator
• Kathmandu University School of Medical Sciences: lead
• World Health Organization: collaborator

Study Sites (1)

Institute for Implementation Science and Health

Kavre, Bagmati, Nepal

Location

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Related Links

• World Health Organization, Ministry of Health and Population. Multisectoral Action Plan for the Prevention and Control of Non Communicable Diseases (2014-2020)

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 16, 2023
• First Posted: December 11, 2023
• Study Start: January 5, 2024
• Primary Completion: March 16, 2025
• Study Completion: May 1, 2025
• Last Updated: January 13, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

NE (1)