An interventional study of Integrated management of hypertension and diabetes using group care approach in Hypertension (HTN) and Diabetes (DM), sponsored by Kathmandu University School of Medical Sciences. Recruiting at 1 site in Nepal. Open to participants aged 30 Years and older. Per ClinicalTrials.gov, last updated 2026-03-10.
Sponsored by Kathmandu University School of Medical Sciences · Not applicable, Interventional, and Health services research
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.
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:
6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.
This study's planned enrollment of 398 is above the median of 100 across 4,575 interventional studies indexed under Hypertension.
Browse Hypertension studies →Kathmandu University School of Medical Sciences is the lead sponsor of 26 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Behavioral: Integrated management of hypertension and diabetes using group care approach
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.
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.
Reach
The proportion of the target population that participates in the intervention.
Time frame: 12 months
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
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
Mean systolic blood pressure (BP) (mmHg)
The net change in mean systolic BP between intervention and control.
Time frame: 12 months
Mean glycated hemoglobin (%)
The net change in mean hba1c levels between intervention and control group.
Time frame: 12 months
Physical activity
The proportion engaged in moderate physical activity (2.5 hours per week) measured at baseline and follow up
Time frame: 12 months
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
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
Hypertension knowledge
The proportion of people with knowledge on hypertension at baseline and followup
Time frame: 12 months
Diabetes knowledge
The proportion of people with knowledge on diabetes at baseline and followup
Time frame: 12 months
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
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Kathmandu University School of Medical Sciences