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Group-Care for Hypertension and Diabetes Management in Nepal

Sponsor: Icahn School of Medicine at Mount Sinai • ClinicalTrials.gov ID: NCT07439380

Registry updated: 2026-08-31

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Description

Hypertension and diabetes represent significant and growing public health challenges in Nepal, particularly in underserved communities. Traditional individual-based care approaches may not adequately address the multifaceted needs of patients with these chronic conditions in resource-limited settings. The group care model, which combines peer support, education, and clinical care, offers a promising alternative that could enhance patient outcomes. This protocol outlines a dual cluster randomized controlled trial (DRCT) using a hybrid type II design to evaluate the effectiveness of a group care model for improving the control and management of hypertension and diabetes in four municipalities in Nepal. The trial will also evaluate the implementation outcomes of fidelity and economic costs. The researchers will assess the effect of the group care model on clinical outcomes. The primary outcomes will be the proportion of patients with controlled versus uncontrolled blood pressure (among patients with hypertension) and the proportion of patients with controlled versus uncontrolled hemoglobin A1c (among patients with diabetes) at 6 and 12 months. The researchers will conduct a three-arm comparison (control vs. low intensity strategies vs. high intensity strategies), with additional pairwise contrasts to examine differences in effectiveness. The researchers will also evaluate intervention fidelity in the two intervention groups and conduct an economic analysis. Each cluster, representing a health facility, will be randomly allocated to one of the three arms after baseline data collection and prior to initiating the intervention phase. The low intensity arm will receive the group care model with standard implementation support, while the high intensity arm will receive the group care model with enhanced implementation strategies. The control arm will continue with the standard of care offered in the nearest health facility, including hypertension and diabetes detection and management based on PEN protocols 1 and 2. After study completion, control facilities will be offered training on the group care model.

Interventions

Low Intensity Community-Based Group NCD Care (Behavioral)
A community-based group care model for hypertension and diabetes management, facilitated by HWs and FCHVs, delivered with low-intensity implementation strategies, including: * Clinical supervision to FCHVs and HWs at baseline, midline and endline only * Remote quarterly refresher sessions on group care model * Initial governmental meetings * One-time training on data entry forms at initiation of study
High Intensity Community-Based Group NCD Care (Behavioral)
A community-based group care model for hypertension and diabetes management, facilitated by HWs and FCHVs, delivered with high-intensity implementation strategies including: * Frequent intensive clinical supervision for HWs/FCHVs * Quarterly refresher sessions and monthly remote check-ins about group care * Partnering with municipalities through regular meetings, goal to supplement programming with local governmental funding * Intensive data review (quarterly) with structured feedback and regular quality checks of data entry

Eligibility criteria

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

Conditions

Hypertension Diabetes

Locations

Dhulikhel Hospital — Dhulikhel, Nepal

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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