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NCT07400133

Assessing Feasibility of a Digital Health Intervention for Multiple Long-Term Condition Care in Primary Health Settings in India and Nepal

Sponsor: Centre for Chronic Disease Control, India

View on ClinicalTrials.gov

Summary

This observational, non-randomized, single-arm pilot study aims to assess the acceptability, feasibility, usability, and implementation fidelity of a co-designed multi-component digital health intervention to support the management of multiple long-term conditions (MLTCs) in Government primary health care settings. The study is conducted among adult patients with MLTCs attending rural primary health centres and the primary care providers (Medical officers and Staff Nurse) delivering services at these facilities in India and Nepal. The intervention comprises an electronic decision support system (EDSS) to facilitate evidence-based clinical decision-making, assisted telemedicine model to enable timely specialist consultations, and a patient-facing mobile application-supported by community champions to enhance care coordination, self-management, and treatment adherence. Participants will engage with these components over a three month implementation period and will complete surveys and qualitative interviews, alongside routine supervision checklists and system-usage analytics, to generate implementation and usability data. The study will be implemented across six rural primary health centres in Jodhpur (Rajasthan) and Anakapalli (Andhra Pradesh), India, and Kathmandu, Nepal, enrolling approximately 30 patients per site along with all participating health care providers. Findings from this pilot will inform refinement of the intervention, study tools, and implementation strategies, and will provide critical evidence on contextual adaptability to support the design of a subsequent cluster randomized controlled trial under the NIHR Global Health Research Centre for Multiple Long-Term Conditions.

Official title: NIHR Global Health Research Centre for Multiple Long-Term Conditions Pilot Study to Assess the Acceptability, Feasibility, Fidelity and Usability of a Co-designed Intervention to Improve Management of Multiple Long-term Conditions

Key Details

Gender

All

Age Range

40 Years - 100 Years

Study Type

OBSERVATIONAL

Enrollment

180

Start Date

2026-02-15

Completion Date

2026-05-30

Last Updated

2026-02-10

Healthy Volunteers

No

Interventions

OTHER

Electronic Decision Support System (EDSS)

Algorithms were developed for hypertension, diabetes, mental health conditions, respiratory diseases, backache, substance use, and vision and hearing problems. Researchers reviewed national and LMIC guidelines and created flowcharts covering the full care pathway from screening and tests to diagnosis, treatment, referral, and follow-up. After multiple expert reviews, the final flowcharts were converted into structured datasets and workflow variables, forming the basis of the EDSS, which guides health workers step by step in delivering consistent care

OTHER

Assisted telemedicine

Assisted telemedicine refers to a system where participants get help to access teleconsultations through two models. A full Model, where they visit PHCs and connect with remote doctors through telemedicine hubs, and a backpack Model, where portable kits deliver telemedicine services in remote or hard to reach areas. Both models are adapted to local needs to ensure continuous care and better access to specialist consultations.

OTHER

Patient facing mobile app and Community champions (Care coordinators)

The patient-facing app enables participants to track key health indicators, receive medication and appointment reminders, and access educational content. Community champions help to develop patient networks to improve disease management and empower them in their self care.

Locations (6)

Makavarapalem Primary Health Care Center

Narsīpatnam, Anakapalli, India

Nathavaram Primary Health Care Center

Narsīpatnam, Anakapalli, India

Beru,Primary Health Care Center

Bhopālgarh, Jodupur, India

Pheench, Primary Health Care Center

Phalodi, Jodupur, India

Dadhikot Primary Health Care Center

Bhaktapur, Bagmati, Nepal

Kathmandu, Urban health promotion center

Kathmandu, Bagmati, Nepal