Group-Care for Hypertension and Diabetes Management in Nepal

NCT07439380 | Not Yet Recruiting

• 1 other identifier: STUDY-25-01609
• Study Type: interventional
• Target: 1,110
• Locations: 1 country
• Sites: 1

Brief Summary

Hypertension and diabetes represent significant and growing public health challenges in Nepal, particularly in underserved communities. Traditional individual-based care approaches may not adequately address the multifaceted needs of patients with these chronic conditions in resource-limited settings. The group care model, which combines peer support, education, and clinical care, offers a promising alternative that could enhance patient outcomes. This protocol outlines a dual cluster randomized controlled trial (DRCT) using a hybrid type II design to evaluate the effectiveness of a group care model for improving the control and management of hypertension and diabetes in four municipalities in Nepal. The trial will also evaluate the implementation outcomes of fidelity and economic costs. The researchers will assess the effect of the group care model on clinical outcomes. The primary outcomes will be the proportion of patients with controlled versus uncontrolled blood pressure (among patients with hypertension) and the proportion of patients with controlled versus uncontrolled hemoglobin A1c (among patients with diabetes) at 6 and 12 months. The researchers will conduct a three-arm comparison (control vs. low intensity strategies vs. high intensity strategies), with additional pairwise contrasts to examine differences in effectiveness. The researchers will also evaluate intervention fidelity in the two intervention groups and conduct an economic analysis. Each cluster, representing a health facility, will be randomly allocated to one of the three arms after baseline data collection and prior to initiating the intervention phase. The low intensity arm will receive the group care model with standard implementation support, while the high intensity arm will receive the group care model with enhanced implementation strategies. The control arm will continue with the standard of care offered in the nearest health facility, including hypertension and diabetes detection and management based on PEN protocols 1 and 2. After study completion, control facilities will be offered training on the group care model.

Conditions

Hypertension; Diabetes

Keywords

Dual randomized control trial; Group-based care; Hypertension; Diabetes; Implementation science; NCDs

Outcome Measures

Primary Outcomes (2)

• Proportion of patients with NCD Control from baseline to follow-up

  NCD control will be defined as follows: 1. For patients with ONLY hypertension: systolic blood pressure \< 140 mmHg AND diastolic blood pressure \< 90 mm Hg; 2. For patients with only diabetes: HbA1c,% \<7 for diabetes; 3. For patients with hypertension and diabetes: SBP\< 130 and DBP\< 80 AND HbA1c \< 7%

  at 6 months from start of intervention, and 12 months from start of intervention

• Fidelity Score

  Will be determined in high-intensity and low-intensity implementation arms as follows: Fidelity Components Frequency = % of group visits conducted as per protocol. Duration = % attendance at group care session. Coverage of appropriate NCD reading = % of BP and/or blood sugar readings completed as per protocol Coverage of medication = % of visits where medication appropriately received Fidelity Score Calculation Fidelity Scoring: Each component receives a standardized score from 0 to 100 where 0 = non-adherence and 100 = full adherence. The overall fidelity score will be calculated per patient using this formula: Fidelity Score = Σ (W × C) / 4, where W = 25% (equal weight per component) and C = score for each component.

  at 6 months and at 12 months from start of intervention

Secondary Outcomes (12)

• Change in Systolic BP (mmHg) and Diastolic BP

  at baseline, 6 months and 12 months

• Hb A1c (percentage)

  at baseline, 6 months and 12 months

• Hypertension Knowledge Level Scale (HK-LS)

  at baseline and 12 months

• Diabetes Knowledge Questionnaire (DKQ)

  at baseline and 12 months

• Hill-Bone Blood Pressure Scale

  at baseline and 12 months

Study Arms (3)

Usual Care

NO INTERVENTION

390 participants, at the 13 health facilities selected for the control arm, with hypertension will be linked to usual care.

Low Intensity Implementation

EXPERIMENTAL

360 participants, affiliated with the 12 health facilities, with hypertension and diabetes will be assigned to receive group care with low intensity implementation strategies.

Behavioral: Low Intensity Community-Based Group NCD Care

High Intensity Implementation

EXPERIMENTAL

360 patients, affiliated with the 12 health facilities, with hypertension and diabetes patients will be assigned to receive group care, that will be delivered with high intensity implementation strategies.

Behavioral: High Intensity Community-Based Group NCD Care

Interventions

Low Intensity Community-Based Group NCD Care BEHAVIORAL

A community-based group care model for hypertension and diabetes management, facilitated by HWs and FCHVs, delivered with low-intensity implementation strategies, including: * Clinical supervision to FCHVs and HWs at baseline, midline and endline only * Remote quarterly refresher sessions on group care model * Initial governmental meetings * One-time training on data entry forms at initiation of study

Low Intensity Implementation

High Intensity Community-Based Group NCD Care BEHAVIORAL

A community-based group care model for hypertension and diabetes management, facilitated by HWs and FCHVs, delivered with high-intensity implementation strategies including: * Frequent intensive clinical supervision for HWs/FCHVs * Quarterly refresher sessions and monthly remote check-ins about group care * Partnering with municipalities through regular meetings, goal to supplement programming with local governmental funding * Intensive data review (quarterly) with structured feedback and regular quality checks of data entry

High Intensity Implementation

Eligibility Criteria

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

You may qualify if:

• Adults aged 18 years and above living in the catchment areas of the 37 health facilities participating in the trial, across the 4 specified municipalities
• Individuals who are newly diagnosed with hypertension (defined as systolic blood pressure 140 mmhg or higher and/or diastolic blood pressure 90 mmHg or higher.) and/or diabetes (defined as fasting blood glucose ≥126 mg/dL, random blood glucose ≥200 mg/dL, or Hgb A1c≥6.5).
• Individuals with previously known diagnoses of hypertension and/or diabetes with records from health facilities record or patient card of individuals.
• Residents of the catchment areas served by the enrolled health facilities in the study sites.

You may not qualify if:

• Individuals with physical or verbal disabilities that would impede their participation in the intervention activities, such as attending and participating in group discussions, counseling sessions, or self-reporting during data collection.
• Pregnant women
• People who may migrate within a year

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• Kathmandu University School of Medical Sciences: collaborator

Study Sites (1)

Dhulikhel Hospital

Dhulikhel, Nepal

Location

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

• Neha Limaye

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Nishtha Balla, MPH

CONTACT

+977 9841049208; nishtha.balla@dhulikhelhospital.org

Archana Shrestha

CONTACT

+977 9801002245; archana@kusms.edu.np

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: 37 health facilities will undergo randomization. The study statistician will generate 10 different combinations of random allocation lists of health facilities to ensure transparency, printed and sealed in envelopes. Stakeholders from local municipalities will participate in a randomization event, where sealed envelopes will be selected and the random allocation of the health facilities will be revealed to all present.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: The researchers will conduct a type II hybrid effectiveness-implementation trial to evaluate both the clinical effectiveness of the group care model and implementation outcomes based on fidelity. The study will use a non-blinded, three-arm, cluster-randomized design, with each cluster representing a health facility.

Study Record Dates

• First Submitted: February 23, 2026
• First Posted: February 27, 2026
• Study Start: April 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Beginning 9 months and ending 36 months following article publication.
• Access Criteria: Researchers who provide a methodologically sound proposal. To achieve aims in the approved proposal. Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in the University's data warehouse but without investigator support other than deposited metadata. Information regarding submitting proposals and accessing data may be found at (Link tbd).

Locations

NE (1)