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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age30+
SponsorKathmandu University School of Medical Sciences

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Design model

Parallel

Treatments tested in this trial

  • Integrated management of hypertension and diabetes using group care approach

    Behavioral

    FCHVs will undergo a 3-day training program on HTN and DM management, including screening, counseling, medication adherence, self-care, and referrals. They will then collaborate with healthcare facilities to conduct one-day hypertension screening camps(outreach clinics). FCHVs will form groups for individuals with hypertension and hold monthly meetings 1-3 days prior to outreach clinic by health facilities to discuss control strategies, review BPlogs, and promote healthcare visits, including family involvement identify uncontrolled and refer to outreach clinics. They will also conduct home visits to those who are not able to join the group care session and also maintain regular communication with health facilities.

Treatment groups

398 Participants
are divided into 2 treatment groups
Group A: 'Group Care' armExperimental treatment 1 intervention
Group B: Regular Facility-based Care ArmNo intervention 0 interventions

Trial outcomes

Primary outcomes

1

Reach

The proportion of the target population that participates in the intervention.

Time frame
12 months
2

Adoption

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.

Time frame
12 months
3

Implementation

The proportion of extent to which the FCHV-led intervention is delivered as intended. This will be measured using observation checklist.

Time frame
12 months
4

Mean systolic blood pressure (BP) (mmHg)

The net change in mean systolic BP between intervention and control.

Time frame
12 months

Secondary outcomes

1

Physical activity

The proportion engaged in moderate physical activity (2.5 hours per week) measured at baseline and follow up

Time frame
12 months
2

Anti hypertension Medication adherence

The proportion adhering to prescribed medication in the past two weeks measured at baseline and follow up

Time frame
12 months
3

Anti-diabetic medicine adherence

The proportion adhering to prescribed medication in the past two weeks measured at baseline and follow up

Time frame
12 months
4

Hypertension knowledge

The proportion of people with knowledge on hypertension at baseline and followup

Time frame
12 months

Other outcomes

Sponsors and contacts

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Kathmandu University School of Medical Sciences

Lead sponsor

Institute for Implementation Science and Health

Collaborator

World Health Organization

Collaborator