Group-based care for managing hypertension and diabetes in Nepal

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This dual cluster randomized trial compares standard care with two levels of group-based NCD care (low and high intensity) across 37 health facilities in four Nepalese municipalities. Groups of 8–10 participants meet monthly with health workers and community volunteers to focus on lifestyle, medication adherence, and peer support. Outcomes include blood pressure control among hypertensive patients and HbA1c among patients with diabetes, measured at 6 and 12 months, along with implementation metrics like fidelity and economic costs. The study uses a hybrid type II design to examine both effectiveness and implementation processes in a resource-limited setting.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Adults aged 18 years and above living in the catchment areas of the 37 health facilities participating in the trial, across the 4 specified municipalities
* Individuals who are newly diagnosed with hypertension (defined as systolic blood pressure 140 mmhg or higher and/or diastolic blood pressure 90 mmHg or higher.) and/or diabetes (defined as fasting blood glucose ≥126 mg/dL, random blood glucose ≥200 mg/dL, or Hgb A1c≥6.5).
* Individuals with previously known diagnoses of hypertension and/or diabetes with records from health facilities record or patient card of individuals.
* Residents of the catchment areas served by the enrolled health facilities in the study sites.

Exclusion Criteria:

* Individuals with physical or verbal disabilities that would impede their participation in the intervention activities, such as attending and participating in group discussions, counseling sessions, or self-reporting during data collection.
* Pregnant women
* People who may migrate within a year

Where it's running

• Dhulikhel Hospital
  Dhulikhel, Nepal Recruiting

Study contacts

• Principal investigator: Neha Limaye — Icahn School of Medicine at Mount Sinai
• Study coordinator: Nishtha Balla, MPH
• Email: nishtha.balla@dhulikhelhospital.org
• Phone: +977 9841049208

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.