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NCT07582380

National Institute for Health and Care Research Global Health Research Centre for Multiple Long-Term Conditions

Sponsor: Centre for Chronic Disease Control, India

View on ClinicalTrials.gov

Summary

Multiple Long-Term Conditions (MLTC), defined as the coexistence of two or more chronic conditions, is increasingly prevalent in India. Despite this, the healthcare system remains largely focused on single-disease management, underscoring the urgent need for integrated, patient-centred approaches that are context-specific, equitable, and resource-sensitive. India's public health infrastructure is undergoing significant reform through the Ayushman Bharat Yojana, which aims to upgrade 150,000 sub-centres and primary health centres into Health and Wellness Centres (HWCs). These centres are designed to provide comprehensive care including prevention, treatment, and rehabilitation to underserved populations. This transformation presents a strategic opportunity to embed multi-morbidity care into the evolving system, supported by the establishment of a Global Health Research Centre dedicated to MLTC. The NIHR Global Health Research Centre for Multiple Long-Term Conditions aims to transform the health system in India and Nepal by improving care for individuals living with MLTC. With chronic conditions on the rise due to epidemiological transitions, particularly among adults aged ≥40, there is an urgent need for integrated, people-centred care models. This project is being implemented in Anakapalli district (Andhra Pradesh), Jodhpur (Rajasthan), Sonipat (Haryana) and Nepal, encompassing both rural and urban contexts. The study is conducted among adult patients with MLTCs attending rural primary 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 and care coordinators to enhance care coordination, self-management, and treatment adherence. At this stage, we have completed the case-mix and health facility assessments, alongside the in-depth interviews to identify challenges faced by patients, caregivers, and health care providers. Currently, we are pilot testing the health intervention in 4 PHCs in India and 2 PHCs in Nepal among 180 participants (30 participants per site). 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 (RCT). In the full RCT, we will evaluate the effectiveness of a health system intervention comprising an electronic clinical decision support system, assisted telemedicine, a patient-facing application, and community champions. The study will be conducted across selected sites in India and Nepal using a cluster randomized controlled design, in which Primary Health Centres (PHCs) are allocated to either the intervention or usual care arm. The intervention includes structured clinical workflows, a digital decision support system, assisted telemedicine, and patient-facing mobile health tools to strengthen continuity and coordination of care. Participants will engage with these components over a six-month implementation period. Data collection will include participant surveys and qualitative interviews, complemented by routine supervision checklists and system usage analytics to assess implementation processes and usability. The study findings will generate robust evidence to inform scalable and context-appropriate models of integrated care for multiple long-term conditions (MLTCs) in primary care settings in low- and middle-income countries. By embedding digital tools and strengthening PHC systems, the intervention aims to improve quality of life, reduce fragmentation of care, and establish a sustainable model for MLTC management.

Key Details

Gender

All

Age Range

40 Years - 100 Years

Study Type

INTERVENTIONAL

Enrollment

3600

Start Date

2026-05-05

Completion Date

2028-08-30

Last Updated

2026-05-12

Healthy Volunteers

Conditions

Chronic Conditions, Multiple Diseases of the Circulatory System Diseases of the Respiratory System Endocrine, Nutritional and Metabolic Diseases Mental, Behavioral and Neurodevelopmental Disorders Diseases of the Musculoskeletal System and Connective Tissue Diseases of the Ear and Mastoid Process Diseases of the Eye and Adnexa

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 enables participants to access teleconsultations with support from health staff through a facility-based model, where patients visit PHCs and connect with remote specialist doctors via telemedicine hubs.

OTHER

Patient-facing app for self-management, supported by care coordination through Community Champions and 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.