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Clinical Trials in India / NCT07400133
Starting soon Observational

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

NCT07400133 · tracked via the Priya Life Science India tracker
Sponsor
Centre for Chronic Disease Control, India
Phase
Observational
Started
2026-02-15
Last updated
2026-02-10

Condition(s) studied

Diseases of the Circulatory SystemDiseases of the Respiratory SystemEndocrine, Nutritional and Metabolic DiseasesMental, Behavioral and Neurodevelopmental DisordersDiseases of the Musculoskeletal System and Connective TissueDiseases of the Eye and AdnexaDiseases of the Ear and Mastoid Process

Investigational drug(s) / intervention(s)

Electronic Decision Support System (EDSS)Assisted telemedicinePatient facing mobile app and Community champions (Care coordinators)

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

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.

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.

Study 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.

Eligibility

Sex
ALL
Min age
40 Years
Max age
100 Years
Healthy volunteers
No
Inclusion Criteria: * Adults aged 40 years or above * Attending the Primary Health Centre (PHC) during the enrollment period * Diagnosed with two or more of the following chronic conditions: 1. Hypertension 2. Diabetes mellitus 3. Depression 4. Anxiety 5. Chronic obstructive pulmonary disease (COPD) 6. Asthma 7. Vision impairment 8. Hearing impairment 9. Osteoarthritis 10. Chronic back pain Exclusion Criteria: * Age \< 40 years * Presence of only one or none of the listed chronic conditions * Pregnant or breastfeeding women * Severe cognitive impairment or dementia that prevents informed consent or or reliable participation * Bedridden or terminally ill individuals with a life expectancy \< 6 month * Current participation in another clinical or interventional research study may interfere with study outcomes * Severe psychiatric illness (e.g., psychosis or bipolar disorder) other than depression or anxiety * Unable or unwilling to provide written informed consent * Severe communication barriers that prevent participation in interviews or questionnaires, even with assistance

Primary outcome measure(s)

Trial sites (6)

FacilityCityRegionStatus
Makavarapalem Primary Health Care Center Narsīpatnam Anakapalli
Nathavaram Primary Health Care Center Narsīpatnam Anakapalli
Beru,Primary Health Care Center Bhopālgarh Jodupur
Pheench, Primary Health Care Center Phalodi Jodupur
Dadhikot Primary Health Care Center Bhaktapur Bagmati
Kathmandu, Urban health promotion center Kathmandu Bagmati

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07400133 on ClinicalTrials.gov ↗ ← All trials in India