Assessing Feasibility of a Digital Health Intervention for Multiple Long-Term Condition Care in Primary Health Settings in India and Nepal
NIHR GHRC MLTC
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
1 other identifier
observational
180
2 countries
6
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Feb 2026
Shorter than P25 for all trials
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 18, 2026
CompletedFirst Posted
Study publicly available on registry
February 10, 2026
CompletedStudy Start
First participant enrolled
February 15, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 15, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
May 30, 2026
CompletedFebruary 10, 2026
February 1, 2026
3 months
January 18, 2026
February 3, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Feasibility of Intervention Implementation
Feasibility will be assessed by successful completion of at least 70% of the planned workflow steps during the pilot phase.
Feasibility outcomes will be tracked throughout the study period and summarized at 3 months (endline)
Secondary Outcomes (4)
Acceptability of Intervention
Acceptability outcomes will be tracked throughout the study period and summarized at 3 months (endline)
Usability of Intervention
Usability will be assessed at 3months (endline) based on post-intervention feedback from healthcare providers and participants
Fidelity of Intervention Implementation
Fidelity will be monitored continuously using supervision checklists and system logs and summarized at 3months (endline).
Quality of Intervention Delivery
Quality of delivery will be monitored continuously through documentation checks, formally assessed monthly, and summarized at 3months (endline)
Study Arms (1)
Pilot Intervention Cohort - Digital Health Intervention for MLTCs
This pilot, single-arm intervention cohort includes adult patients (aged ≥40 years) with multiple long-term conditions (MLTCs) receiving care at selected rural primary health centres in India, along with the primary care providers delivering services at these facilities. Participants will receive a multi-component digital health intervention comprising an Electronic Decision Support System (EDSS) to support guideline-based clinical decision-making for MLTC management, assisted telemedicine (facility-based and portable models) to enable specialist consultations, and a patient-facing mobile application to strengthen self-management, treatment adherence, and continuity of care. The cohort will be followed over a three-month pilot implementation period to assess the acceptability, usability, feasibility, and implementation fidelity of the intervention in routine primary care settings.
Interventions
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 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.
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.
Eligibility Criteria
The study population includes adult patients with multiple long-term conditions and primary health care providers from six rural primary health centres in India and Nepal. Study sites include two centres each in Jodhpur, Rajasthan; Anakapalli, Andhra Pradesh; and Bagmathi provience, Nepal. At each site, approximately 30 patients with multiple long-term conditions and all participating health care providers will be enrolled. Patients will be recruited from routine care at participating primary health centres, and providers will be recruited from staff involved in delivering the intervention.
You may qualify if:
- 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:
- Hypertension
- Diabetes mellitus
- Depression
- Anxiety
- Chronic obstructive pulmonary disease (COPD)
- Asthma
- Vision impairment
- Hearing impairment
- Osteoarthritis
- Chronic back pain
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Makavarapalem Primary Health Care Center
Narsīpatnam, Anakapalli, 531113, India
Nathavaram Primary Health Care Center
Narsīpatnam, Anakapalli, 531115, India
Beru,Primary Health Care Center
Bhopālgarh, Jodupur, 342024, India
Pheench, Primary Health Care Center
Phalodi, Jodupur, 342801, India
Dadhikot Primary Health Care Center
Bhaktapur, Bagmati, 45206, Nepal
Kathmandu, Urban health promotion center
Kathmandu, Bagmati, 1244600, Nepal
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Prabhakaran Dorairaj, M.D., DM
Center for Chronic Disease Control
- PRINCIPAL INVESTIGATOR
Kamlesh Khunti, MD, DM
University of Leicester
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Executive Director
Study Record Dates
First Submitted
January 18, 2026
First Posted
February 10, 2026
Study Start
February 15, 2026
Primary Completion
May 15, 2026
Study Completion
May 30, 2026
Last Updated
February 10, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
- Time Frame
- 01-06-2026 till 30-12-2027
- Access Criteria
- Only bonafide researchers with a valid research question shall be provided data. Interested researchers shall write to Prof. Prabhakaran (dprabhakaran@ccdcindia.org) with a concept note and necessary approvals as applicable.
De-identified data collected for the study will be shared with bonafide researchers with a valid research question. Request may be addressed to Prof. Prabhakaran - dprabhakaran@ccdcindia.org