Group-Care for Hypertension and Diabetes Management in Nepal

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.

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