Actively Recruiting

Phase Not Applicable
Age: 30Years +
All Genders
ID07432126

Community Health Workers Led Integrated Management of Hypertension and Diabetes in Nepal

Led by Kathmandu University School of Medical Sciences · Updated on 2026-03-10

398

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

Sponsors

K

Kathmandu University School of Medical Sciences

Lead Sponsor

I

Institute for Implementation Science and Health

Collaborating Sponsor

AI-Summary

What this Trial Is About

Hypertension and diabetes are major health challenges worldwide, leading to significant deaths and complications like stroke, heart disease, and kidney failure. In Nepal, these conditions are common, often undiagnosed or poorly managed, especially among marginalized populations. This research evaluates a community-based approach using Female Community Health Volunteers (FCHVs) to improve integrated management of hypertension and diabetes compared to standard facility-based care, focusing on both implementation and health outcomes over 12 months. The study is a cluster randomized controlled trial in 12 health facilities in Namobuddha Municipality, Nepal. The intervention group involves FCHVs trained for three days to screen, counsel, monitor blood pressure and blood sugar, form peer groups, and coordinate care including home visits for those unable to attend group sessions. The control group receives regular facility-based care without additional group support. Monthly group meetings and referrals for uncontrolled cases are key components of the intervention. Participants, all adults aged 30 or older with hypertension and at risk or diagnosed with diabetes, will be followed for 12 months. Data collection includes blood pressure and glycated hemoglobin measurements, lifestyle questionnaires, medication adherence checks, and qualitative interviews. FCHVs will track activities monthly, and researchers will assess reach, adoption, implementation, and maintenance of the program, alongside health outcomes like blood pressure and blood sugar control.

CONDITIONS

Brief Title

Community Health Workers Led Integrated Management of Hypertension and Diabetes in Nepal

Who Can Participate

Age: 30Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 30 years or older
  • Diagnosed with high blood pressure of 140/90 mmHg or currently taking hypertension medication
  • Have a high blood sugar of 6.5% or more (HbA1c) or are under diabetes medication
  • Able to provide informed consent
Not Eligible

You will not qualify if you...

  • Any form of disabilities limiting participation in the study
  • Severe illness requiring bed rest
  • Pregnant women due to their special health needs

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Outreach Clinic Group Care

Duration - 12 months

Participants in the intervention arm join monthly group care sessions led by trained Female Community Health Volunteers (FCHVs) to manage hypertension and diabetes. Sessions include blood pressure and blood glucose monitoring, lifestyle counseling, medication adherence support, and referral to health facilities. Home visits are made to participants unable to attend group sessions.

Monthly group care sessions plus home visits as needed

Regular Facility-based Care

Duration - 12 months

Participants in the control arm receive regular health facility-based care for hypertension and diabetes according to Ministry of Health guidelines without additional group care support.

Care provided according to routine facility schedules

Data Collection and Monitoring

Duration - 12 months

Participants undergo baseline, midline, and endline assessments including blood pressure and glycated hemoglobin measurements, face-to-face interviews on lifestyle factors and medication adherence, as well as qualitative interviews to evaluate intervention effectiveness and implementation.

3 assessment visits (baseline, midline, endline) plus monthly follow-up check-ins

Trial Site Locations

Total: 1 location

1

Institute for Implementation Science and Health

Kavre, Bagmati, Nepal

Actively Recruiting

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Research Team

A

Archana Shrestha, PhD

B

Bihungum Bista, MPH

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

HEALTH_SERVICES_RESEARCH

Number of Arms

2

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