Community Health Workers Led Integrated Management of Hypertension and Diabetes in Nepal
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 398
- 试验地点
- 1
- 主要终点
- Reach
研究概览
简要总结
Hypertension (HTN) and diabetes mellitus are significant global public health challenges, contributing to 13.5% of premature deaths, 54% of incident strokes, and 47% of coronary heart disease cases (HTN), and increasing risks of cardiovascular diseases, kidney failure, and other complications (diabetes). In Nepal, HTN prevalence is 24.5% and diabetes affects 5.8% of adults (2019 Nepal STEPS Survey), with many cases undiagnosed or poorly managed, and an estimated 60% co-morbidity among diabetic individuals. Nepal's Package of Essential Non-Communicable Diseases (PEN), implemented since 2017, targets both conditions, but multi-level barriers limit its facility-based effectiveness. This study addresses the need for cost-effective, evidence-based strategies for HTN and diabetes management in low-resource settings, focusing on marginalized populations. It proposes a Type II hybrid implementation-effectiveness study with two objectives: (1) evaluate implementation outcomes (reach, adoption, implementation, maintenance) of the Female Community Health Volunteers (FCHVs)-led integrated HTN and diabetes management using the RE-AIM framework; (2) assess effectiveness compared to facility-based PEN on systolic blood pressure and fasting blood sugar at 12 months. FCHVs will deliver integrated health education, form peer groups, and coordinate care. Using a mixed-method approach, the study involves a cluster randomized controlled trial with participants, collecting quantitative data on implementation, supplemented by in-depth interviews (8-16 patients) and focus group discussions (2 FGDs with FCHVs), with qualitative tracking logs. The intervention adapts a prior FCHV-led HTN trial to integrate diabetes management. FCHVs will receive 3-day training on screening, counseling, BP and blood sugar monitoring, and referrals for both conditions. Mass screening will identify HTN and diabetes cases, forming monthly FCHV groups for lifestyle counseling, BP, and glucose tracking, with family involvement. Monthly referrals will link uncontrolled cases to facilities. This aims to enhance integrated HTN and diabetes management, fostering community engagement and healthcare coordination, with findings to inform scalable NCD strategies in Nepal.
详细描述
Study design:
This study is an Type II hybrid effectiveness-implementation study, a cluster randomized controlled trial to evaluate the implementation and effectiveness of a community-based intervention for managing hypertension-diabetes co-morbidity in Namobuddha Municipality, Nepal using RE-AIM framework. The study has 12 health facilities in 11 wards of Namobuddha Municipality. The 12 facilities serve as study clusters. Clusters are randomly assigned to the intervention and control arm. The extension of the study will include integrated management of hypertension and diabetes with two arms.
Intervention Arm: FCHVs and Frontline Health Workers (FLHWs) will continue hypertension-related activities while integrating diabetes screening, lifestyle counseling, and referral support.
Control Arm: Participants will receive standard/regular health facility based hypertension and diabetes care per the Ministry of Health and Population (MoHP) guidelines without additional diabetes screening and support.
Study site:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •30 years or older
- •have a high blood pressure of 140/90 mmHg or under hypertension medication
- •have a high blood sugar of 6.5% or more (hba1c) or under diabetes medication are able to provide informed consent
排除标准
- •any form of disabilities limiting participation in the study
- •severe illness requiring bed rest, and
- •pregnant women, due to their special health needs.
研究组 & 干预措施
'Group Care' arm
FCHVs will under 3 days trainings and conduct group care session in collaboration with health care workers from health facilities during the outreach clinics (ORC) and conduct home visit to those people who are unable to join the group care session. The FCHVs will maintain registry of the patients under the group care and log their blood pressure and blood sugar.
干预措施: Integrated management of hypertension and diabetes using group care approach (Behavioral)
Regular Facility-based Care Arm
The participants in the control arm will receive the regular health facility based care from the health facilities. They will not receive any group care sessions.
结局指标
主要结局
Reach
时间窗: 12 months
The proportion of the target population that participates in the intervention.
Adoption
时间窗: 12 months
The proportion of health facilities that are willing or are adopting the group-care intervention. Minutes of consultative meetings between investigating team and health facility in-charges will provide evidence of the adoption by the health facilities.
Implementation
时间窗: 12 months
The proportion of extent to which the FCHV-led intervention is delivered as intended. This will be measured using observation checklist.
Mean systolic blood pressure (BP) (mmHg)
时间窗: 12 months
The net change in mean systolic BP between intervention and control.
Mean glycated hemoglobin (%)
时间窗: 12 months
The net change in mean hba1c levels between intervention and control group.
次要结局
- Physical activity(12 months)
- Anti hypertension Medication adherence(12 months)
- Anti-diabetic medicine adherence(12 months)
- Hypertension knowledge(12 months)
- Diabetes knowledge(12 months)
研究者
Archana Shrestha
Professor
Kathmandu University School of Medical Sciences
