Group-Care for Hypertension and Diabetes Management in Nepal

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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
• Поведенческое 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 regul

Первичные конечные точки

• Proportion of patients with NCD Control from baseline to follow-up [Срок оценки: at 6 months from start of intervention, and 12 months from start of intervention]
• Fidelity Score [Срок оценки: at 6 months and at 12 months from start of intervention]

Вторичные конечные точки (12)

• Change in Systolic BP (mmHg) and Diastolic BP [Срок оценки: at baseline, 6 months and 12 months]
• Hb A1c (percentage) [Срок оценки: at baseline, 6 months and 12 months]
• Hypertension Knowledge Level Scale (HK-LS) [Срок оценки: at baseline and 12 months]
• Diabetes Knowledge Questionnaire (DKQ) [Срок оценки: at baseline and 12 months]
• Hill-Bone Blood Pressure Scale [Срок оценки: at baseline and 12 months]
• Self Efficacy for Managing Chronic Disease [Срок оценки: at baseline and 12 months]
• Smoking amount [Срок оценки: at baseline and 12 months]
• Alcohol amount [Срок оценки: at baseline and 12 months]
• Metabolic equivalents (MET) minutes per week. [Срок оценки: at baseline and 12 months]
• Total program delivery costs [Срок оценки: 12 months]
• Costs of strategies [Срок оценки: 12 months]
• Cost per participant [Срок оценки: 12 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Nepal · 1 центр

• Dhulikhel Hospital — Dhulikhel

Идентификаторы

NCT: NCT07439380 · STUDY-25-01609

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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