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 volunteersQualifiers
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
Parallel
Treatments tested in this trial
Integrated management of hypertension and diabetes using group care approach
BehavioralFCHVs 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
Trial outcomes
Primary outcomes
Reach
The proportion of the target population that participates in the intervention.
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.
Implementation
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)
The net change in mean systolic BP between intervention and control.
Secondary outcomes
Physical activity
The proportion engaged in moderate physical activity (2.5 hours per week) measured at baseline and follow up
Anti hypertension Medication adherence
The proportion adhering to prescribed medication in the past two weeks measured at baseline and follow up
Anti-diabetic medicine adherence
The proportion adhering to prescribed medication in the past two weeks measured at baseline and follow up
Hypertension knowledge
The proportion of people with knowledge on hypertension at baseline and followup
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