Community Health Workers Led Integrated Management of Hypertension and Diabetes in Nepal

Kathmandu University School of Medical Sciences

Status: Enrolling

Conditions: Diabetes (DM); Hypertension (HTN)

Treatments: Behavioral: Integrated management of hypertension and diabetes using group care approach

Study type: Interventional

Funder types: Other

Identifiers

NCT07432126

296

Details and patient eligibility

About

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.

Full description

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:

The study will occur in Namobuddha Municipality, Kavrepalanchowk, involving 12 basic health facilities with FCHVs.

Study population:

At the facility level, the investigators will include basic health facilities that have implemented PEN, excluding those who are not within the network of Nepal government health system. There are 520 hypertensive patients enrolled in the FCHV-led hypertension trial, allowing for long-term follow-up and assessment of diabetes risk and management. Participants will be hypertensive patients previously enrolled in the FCHV-led hypertension study, along with newly identified individuals meeting the following criteria: Adults aged 30 years and above Diagnosed with hypertension and either at risk of diabetes or diagnosed with type 2 diabetes mellitus (T2DM) (based on WHO diagnostic criteria); Residing in Namobuddha Municipality.

Data Collection Procedure:

The investigators will use quantitative and qualitative tools to measure our primary outcomes. The investigators will collect the following baseline and endline data that will be utilized for this study: sociodemographic data (age, gender, marital status, education, occupation, and income) using the validated STEPS survey questionnaire. Additionally, trained research assistants will collect data using face-to-face interviews on lifestyle factors, including diet quality (using the diet quality questionnaire), physical activity (using a global physical activity questionnaire), alcohol consumption (drinks per week), smoking, knowledge of hypertension and diabetes, and Hill bone medication adherence. Blood pressure will be taken at baseline, midline and endline; glycated hemoglobin will also be measured at baseline, midline and endline, with a trained phlebotomist collecting blood samples from participants' communities and transporting them to the Dhulikhel Hospital laboratory for testing. For process tracking, investigators will build on information about implementation strategies and diabetes management based on our established process tracking systems. FCHVs will conduct group care meeting 1-3 days prior to the PHC/ORCs. Each group care session will include measurement of blood pressure and blood glucose using automated blood pressure machine and portable glucometer respectively, by FCHVs. Healthcare workers will ask FCHVs to complete a monthly checklist to capture completed intervention activities, including records of patients attended. Study staff will make monthly phone calls to healthcare workers to ensure data collection. The system will also capture costs associated with implementation. The investigators will validate the process tracking measures against data collected in the community survey. Additionally, investigators will maintain qualitative tracking logs to document meetings with FCHVs and healthcare workers. In-depth interviews will be conducted with 8-16 patients regarding their overall experience, along with 8-16 key informant interviews with health care workers and two focus group discussions with FCHVs to understand the intervention fidelity.

Data Collection Tools/ Measures:

The study will use a mix of standardized and adapted tools to collect data on hypertension and diabetes. The WHO STEPS questionnaire, Global Physical Activity Questionnaire (GPAQ), Hill bone medicine adherence and the diet quality questionnaire are all validated tools with established reliability and psychometric properties in LMIC settings, including Nepal. Clinical measurements will be taken using validated BP monitors, and HbA1c tests. Monthly follow-up checklists and qualitative interview/FGD guides are developed based on national NCD protocols and implementation frameworks. These tools underwent expert review to ensure content validity.

Data analysis:

1. The investigators will compute estimates of adoption, implementation, reach, and maintenance with appropriate 95% confidence intervals. Reach is defined as the percentage of FCHVs implementing the patient group meetings; at the client level, the percentage of diabetes patients with hypertension in the community who know their high blood pressure status. Adoption is defined as the percentage of health facilities asked to participate in adopting the integrated management of hypertension and diabetes through the FCHV-led program, i.e., where FCHVs complete the initial training session. Program implementation is defined as the percentage of female community health volunteers conducting monthly meetings, (2) group care sessions by FCHVs to the target clients, and (3) FCHVs submitting monthly reports. In addition, the investigators will explore facilitators and barriers to implementation. Maintenance is defined as covering direct and indirect costs for program upkeep.
2. For qualitative FGDs and interviews, investigators will perform abductive analysis, starting with inductive codes (e.g., those emerging from the data) and mapping them to deductive CFIR constructs. RAs will maintain field notebooks to record observed behaviors of providers and patients relevant to implementation.26
3. The baseline characteristics will be presented as the mean (standard deviation) or median (interquartile) for continuous and frequency (%) for categorical variables. Primary outcome analyses will include a generalized estimating equation to identify the link, exchangeable correlation, and robust variance, separately conducted for blood pressure and glycated hemoglobin (%) as primary outcomes.
4. The investigators will conduct a mixed-methods assessment of the implementation outcomes, combining data from quantitative tools with in-depth interviews.

Enrollment: 398 estimated patients

Sex: All

Ages: 30+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• any form of disabilities limiting participation in the study
• severe illness requiring bed rest, and
• pregnant women, due to their special health needs.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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398 participants in 2 patient groups

'Group Care' arm

Experimental group

Description:

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.

Treatment:

Behavioral: Integrated management of hypertension and diabetes using group care approach

Regular Facility-based Care Arm

No Intervention group

Description:

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.