NCT07432126 Community Health Workers Led Integrated Management of Hypertension and Diabetes in Nepal
| NCT ID | NCT07432126 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Kathmandu University School of Medical Sciences |
| Condition | Hypertension (HTN) |
| Study Type | INTERVENTIONAL |
| Enrollment | 398 participants |
| Start Date | 2025-12-14 |
| Primary Completion | 2027-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 398 participants in total. It began in 2025-12-14 with a primary completion date of 2027-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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.
Contact & Investigator
Archana Shrestha, PhD
PRINCIPAL INVESTIGATOR
Kathmandu University School of Medical Sciences
Frequently Asked Questions
Who can join the NCT07432126 clinical trial?
This trial is open to participants of all sexes, aged 30 Years or older, studying Hypertension (HTN). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07432126 currently recruiting?
Yes, NCT07432126 is actively recruiting participants. Contact the research team at archana@kusms.edu.np for enrollment information.
Where is the NCT07432126 trial being conducted?
This trial is being conducted at Kavre, Nepal.
Who is sponsoring the NCT07432126 clinical trial?
NCT07432126 is sponsored by Kathmandu University School of Medical Sciences. The principal investigator is Archana Shrestha, PhD at Kathmandu University School of Medical Sciences. The trial plans to enroll 398 participants.