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

NCT07432126 | Recruiting DMC

• 1 other identifier: 296
• Study Type: interventional
• Target: 398
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension (HTN); Diabetes (DM)

Keywords

disease management; hypertension; diabetes; community health workers; intervention

Outcome Measures

Primary Outcomes (5)

• Reach

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

  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.

  12 months

• Implementation

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

  12 months

• Mean systolic blood pressure (BP) (mmHg)

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

  12 months

• Mean glycated hemoglobin (%)

  The net change in mean hba1c levels between intervention and control group.

  12 months

Secondary Outcomes (5)

• Physical activity

  12 months

• Anti hypertension Medication adherence

  12 months

• Anti-diabetic medicine adherence

  12 months

• Hypertension knowledge

  12 months

• Diabetes knowledge

  12 months

Study Arms (2)

'Group Care' arm

EXPERIMENTAL

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

Regular Facility-based Care Arm

NO INTERVENTION

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.

Interventions

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.

'Group Care' arm

Eligibility Criteria

• Age: 30 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Kathmandu University School of Medical Sciences: lead
• Institute for Implementation Science and Health: collaborator
• World Health Organization: collaborator

Study Sites (1)

Institute for Implementation Science and Health

Kavre, Bagmati, Nepal

RECRUITING

Related Publications (13)

• Evans J, Ha H, White PT. Evaluating the effectiveness of community health worker interventions on glycaemic control in type 2 diabetes mellitus: a systematic review and meta-analysis. BMJ Open. 2025 Jul 15;15(7):e096651. doi: 10.1136/bmjopen-2024-096651.

  PMID: 40664405 BACKGROUND

• Kim MT, Hill MN, Bone LR, Levine DM. Development and testing of the Hill-Bone Compliance to High Blood Pressure Therapy Scale. Prog Cardiovasc Nurs. 2000 Summer;15(3):90-6. doi: 10.1111/j.1751-7117.2000.tb00211.x.

  PMID: 10951950 BACKGROUND

• Han HR, Chan K, Song H, Nguyen T, Lee JE, Kim MT. Development and evaluation of a hypertension knowledge test for Korean hypertensive patients. J Clin Hypertens (Greenwich). 2011 Oct;13(10):750-7. doi: 10.1111/j.1751-7176.2011.00497.x. Epub 2011 Jul 14.

  PMID: 21974763 BACKGROUND

• Aryal KK, Mehata S, Neupane S, Vaidya A, Dhimal M, Dhakal P, Rana S, Bhusal CL, Lohani GR, Paulin FH, Garg RM, Guthold R, Cowan M, Riley LM, Karki KB. The Burden and Determinants of Non Communicable Diseases Risk Factors in Nepal: Findings from a Nationwide STEPS Survey. PLoS One. 2015 Aug 5;10(8):e0134834. doi: 10.1371/journal.pone.0134834. eCollection 2015.

  PMID: 26244512 BACKGROUND

• Murray LK, Dorsey S, Bolton P, Jordans MJ, Rahman A, Bass J, Verdeli H. Building capacity in mental health interventions in low resource countries: an apprenticeship model for training local providers. Int J Ment Health Syst. 2011 Nov 18;5(1):30. doi: 10.1186/1752-4458-5-30.

  PMID: 22099582 BACKGROUND

• Gearing RE, El-Bassel N, Ghesquiere A, Baldwin S, Gillies J, Ngeow E. Major ingredients of fidelity: a review and scientific guide to improving quality of intervention research implementation. Clin Psychol Rev. 2011 Feb;31(1):79-88. doi: 10.1016/j.cpr.2010.09.007. Epub 2010 Oct 7.

  PMID: 21130938 BACKGROUND

• Jindal D, Sharma H, Gupta Y, Ajay VS, Roy A, Sharma R, Ali M, Jarhyan P, Gupta P, Srinivasapura Venkateshmurthy N, Ali MK, Narayan KMV, Prabhakaran D, Weber MB, Mohan S, Patel SA, Tandon N. Improving care for hypertension and diabetes in india by addition of clinical decision support system and task shifting in the national NCD program: I-TREC model of care. BMC Health Serv Res. 2022 May 23;22(1):688. doi: 10.1186/s12913-022-08025-y.

  PMID: 35606762 BACKGROUND

• Labhardt ND, Balo JR, Ndam M, Grimm JJ, Manga E. Task shifting to non-physician clinicians for integrated management of hypertension and diabetes in rural Cameroon: a programme assessment at two years. BMC Health Serv Res. 2010 Dec 14;10:339. doi: 10.1186/1472-6963-10-339.

  PMID: 21144064 BACKGROUND

• Sun Y, Mu J, Wang DW, Ouyang N, Xing L, Guo X, Zhao C, Ren G, Ye N, Zhou Y, Wang J, Li Z, Sun G, Yang R, Chen CS, He J; CRHCP Study Group. A village doctor-led multifaceted intervention for blood pressure control in rural China: an open, cluster randomised trial. Lancet. 2022 May 21;399(10339):1964-1975. doi: 10.1016/S0140-6736(22)00325-7. Epub 2022 Apr 29.

  PMID: 35500594 BACKGROUND

• Gyawali B, Sharma R, Neupane D, Mishra SR, van Teijlingen E, Kallestrup P. Prevalence of type 2 diabetes in Nepal: a systematic review and meta-analysis from 2000 to 2014. Glob Health Action. 2015 Nov 26;8:29088. doi: 10.3402/gha.v8.29088. eCollection 2015.

  PMID: 26613684 BACKGROUND

• Haider MR, Das Gupta R. Inequalities in undiagnosed hypertension among adult Nepalese population: Evidence from a nationally representative survey. Int J Cardiol Hypertens. 2020 Mar 15;5:100026. doi: 10.1016/j.ijchy.2020.100026. eCollection 2020 Jun.

  PMID: 33447755 BACKGROUND

• Petrie JR, Guzik TJ, Touyz RM. Diabetes, Hypertension, and Cardiovascular Disease: Clinical Insights and Vascular Mechanisms. Can J Cardiol. 2018 May;34(5):575-584. doi: 10.1016/j.cjca.2017.12.005. Epub 2017 Dec 11.

  PMID: 29459239 BACKGROUND

• Mendis S, O'Brien E, Seedat YK, Yusuf S. Hypertension and diabetes: entry points for prevention and control of the global cardiovascular epidemic. Int J Hypertens. 2013;2013:878460. doi: 10.1155/2013/878460. Epub 2013 Apr 7. No abstract available.

  PMID: 23653856 BACKGROUND

Related Links

• IDF Diabetes Atlas 2015 (PDF) - 7th Edition (International Diabetes Federation)
• Diabetes and Hypertension Evaluation and Management
• Package of Essential Non-communicable Diseases (PEN) \[Internet\]. Package of Essential Non-communicable Diseases (PEN). \[cited 2022 Sep 25\].
• Global Diet Quality Project - Diet Quality Questionnaire (DQQ) Tools \& Data
• WHO - Global Physical Activity Questionnaire (GPAQ) Analysis Guide, 2012

MeSH Terms

Conditions

Hypertension; Diabetes Mellitus

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Archana Shrestha, PhD

  Kathmandu University School of Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Archana Shrestha, PhD

CONTACT

9801002245; archana@kusms.edu.np

Bihungum Bista, MPH

CONTACT

9845537861; bistabihungum@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 27, 2026
• First Posted: February 25, 2026
• Study Start: December 14, 2025
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

NE (1)