NCT06081010

Brief Summary

The goal of this hybrid type III study incorporating a cluster-randomized trial is to assess the effect of a community health worker-led hypertension prevention and control program (CHPC) on the implementation outcomes and clinical outcomes among patient with hypertension in central Nepal. The main questions it aims to answer are: 1\. What is the level of implementation outcomes, including reach, adoption, implementation fidelity, and maintenance of the CHPC implementation strategy at the patient, provider, and health system levels? 2: What is the effectiveness of the CHPC implementation strategy compared to facility-based intervention on systolic BP via a cluster randomized controlled trial. 3: What is the implementation cost and cost-effectiveness of the CHPC implementation strategy? Participants will receive four follow-up group meetings or home visits every three months for a year by a community health worker. Researchers will compare if there is a significant difference in systolic blood pressure between those who receive this intervention and those who do not receive the intervention in the same community.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,572

participants targeted

Target at P75+ for not_applicable hypertension

Timeline
20mo left

Started Dec 2024

Typical duration for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress46%
Dec 2024Dec 2027

First Submitted

Initial submission to the registry

October 6, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 12, 2023

Completed
1.1 years until next milestone

Study Start

First participant enrolled

December 2, 2024

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

February 6, 2026

Status Verified

February 1, 2026

Enrollment Period

3.1 years

First QC Date

October 6, 2023

Last Update Submit

February 4, 2026

Conditions

Hypertension

Keywords

HypertensionCommunity Health WorkerImplementation Trial

Outcome Measures

Primary Outcomes (4)

  • Reach

    Percentage of CHWs implementing the program

    12 months

  • Adoption

    Percentage of the health facilities asked to participate in adopting the program

    12 months

  • Program implementation

    Percent of the health facility will implement a minimum standard to program implementation

    12 months

  • Maintenance

    Percentage of the health facility that will implement a minimum standard to program implementation during the maintenance period

    24 months

Secondary Outcomes (12)

  • Blood Pressure

    12 months

  • Hypertension Diagnosis Awareness

    12 months

  • Blood Pressure Control

    12 months

  • Physical activity

    12 months

  • Fruits and Vegetables

    12 months

  • +7 more secondary outcomes

Study Arms (2)

Intervention arm

EXPERIMENTAL

Community Health Worker Intervention

Behavioral: Community Health Worker Intervention

Control Group

NO INTERVENTION

Usual care that includes patients visit to health facility based on felt need

Interventions

Community Health Worker InterventionBEHAVIORAL

Trained CHWs will hold group meetings or home visits using a locally adapted manual for HTN management. CHWs will visit homes in their areas and measure BP. High BP clients will be taken to the nearest health center. CHWs will enroll individuals with preHTN and HTN and conduct 4 follow-up group meetings or home visits with them every 3 months. Participants will be invited to attend CHW lead group-based counseling. For those with uncontrolled HTN who have difficulty adhering to prescribed HTN management and not willing or able to attend group meetings, CHWs will conduct follow-up home visits. First meeting (about 90 minutes), CHWs will explain purpose of the meeting and discuss HTN and its consequences. CHWs will apply techniques to initiate dialogue and reflection regarding lifestyle modifications and choose goals based on PEN protocol-2, BP monitoring, and antihypertensive medication use. In subsequent meetings (about 60 minutes), the CHWs will measure BP and address ongoing problems.

Intervention arm

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • High blood pressure (BP) of 140/90 mmHg or higher.

You may not qualify if:

  • Severe illness requiring bed rest
  • Pregnant women, due to their special health needs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Dhulikhel Hospital

Dhulikhel, Nepal

RECRUITING

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Donna Spiegelman, ScD

    Yale University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Donna Spiegelman, ScD

CONTACT

6178355119donna.spiegelman@yale.edu

Eleni Mersiadis

CONTACT

eleni.mersiadis@yale.edu

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

Study Record Dates

First Submitted

October 6, 2023

First Posted

October 12, 2023

Study Start

December 2, 2024

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

February 6, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

NE(1)