NCT07439380

Group-Care for Hypertension and Diabetes Management in Nepal

Group-Care for Hypertension and Diabetes Management in Nepal: A Cluster Randomized Implementation Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,110 (estimated)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

This dual randomized controlled trial will be conducted across 37 health facilities in four municipalities in Nepal- Panchkhal, Bhumlu, Tamakoshi, and Bhimeshwor. The health facilities will be randomly assigned to three arms: control (n =12-13), low intensity implementation (n = 12-13 ), and high intensity implementation (n =12-13). Each intervention cluster will form 2-3 group care groups, each comprising of 8-10 participants, with group sessions facilitated by health workers and Female Community Health Volunteers (FCHVs). The low-intensity arm will receive the group care model with standard implementation support, while the high-intensity strategy arm will receive the group care model with enhanced implementation strategies. Group sessions will be conducted every month, focusing on lifestyle modification, medication adherence, and peer support. The patients in the control arm will continue to receive usual care at the nearest health facility, including hypertension and diabetes detection and management based on the WHO PEN Protocols. After study completion, control facilities will be offered training on the group care model. Data will be collected at baseline, 6 months, and 12 months. The primary effectiveness outcomes will be the proportion of patients with controlled versus systolic blood pressure (among patients with hypertension) and HbA1c (among patients with diabetes), assessed at 6 and 12 months. The primary implementation outcome will be intervention fidelity between the intervention arms, using a fidelity scoring system comparing the high intensity and low intensity intervention groups. The researchers will conduct a three-arm comparison (control vs. low intensity vs. high intensity implementation), with additional pairwise contrasts to examine differences in effectiveness. The researchers will also conduct an economic analysis, looking at program costs and comparing costs between the two intervention arms. This study will seek to determine the effectiveness of the group care model at both high intensity and low intensity doses in managing hypertension and diabetes within the context of Nepal. The researchers anticipate that the intervention will lead to significant improvements in blood pressure and blood glucose control, and improvements in hypertension and diabetes knowledge and medication adherence. Additionally, the trial will explore the scalability of the group care model in other resource-constrained settings. The findings from this study will provide valuable insights into the potential for group care models to address the growing burden of non-communicable diseases in Nepal and similar contexts.

Conditions

• Hypertension
• Diabetes

Interventions

Type	Name	Description
BEHAVIORAL	Low Intensity Community-Based Group NCD Care	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
BEHAVIORAL	High Intensity Community-Based Group NCD Care	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

Timeline

• Start date: 2026-04-01
• Primary completion: 2027-08-01
• Completion: 2027-08-01
• First posted: 2026-02-27
• Last updated: 2026-02-27

Locations

1 site across 1 country: Nepal