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

ConditionsDiseases 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
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40-100
SponsorCentre for Chronic Disease Control, India

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

Adults aged 40 years or above

Attending the Primary Health Centre (PHC) during the enrollment period

Hypertension

Diabetes mellitus

Disqualifiers

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

Trial population

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.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

  • Electronic Decision Support System (EDSS)

    Other intervention

    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

    Other intervention

    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)

    Other intervention

    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.

Treatment groups

180 Participants
are divided into 1 treatment group
Group A: Pilot Intervention Cohort - Digital Health Intervention for MLTCs3 interventions

Trial outcomes

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.

Time frame
Feasibility outcomes will be tracked throughout the study period and summarized at 3 months (endline)

Secondary outcomes

1

Acceptability of Intervention

Acceptability will be assessed as the proportion of health care providers and participants rating the intervention as acceptable, using the Theoretical Framework of Acceptability (TFA). A mean score of ≥4 on a 5-point Likert scale will indicate good acceptability

Time frame
Acceptability outcomes will be tracked throughout the study period and summarized at 3 months (endline)
2

Usability of Intervention

Usability will be assessed using the System Usability Scale (SUS), a 10-item questionnaire generating scores from 0 to 100. A SUS score of ≥70 will indicate good usability.

Time frame
Usability will be assessed at 3months (endline) based on post-intervention feedback from healthcare providers and participants
3

Fidelity of Intervention Implementation

Fidelity will be assessed by adherence to intervention delivery processes and data entry procedures as specified in the approved protocol. Compliance of ≥70% will be considered satisfactory.

Time frame
Fidelity will be monitored continuously using supervision checklists and system logs and summarized at 3months (endline).
4

Quality of Intervention Delivery

Quality of delivery will be assessed as the proportion of reviewed records demonstrating complete and accurate documentation, with a target of ≥75% indicating acceptable quality

Time frame
Quality of delivery will be monitored continuously through documentation checks, formally assessed monthly, and summarized at 3months (endline)

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre for Chronic Disease Control, India

Lead sponsor

All India Institute of Medical Sciences, Jodhpur

Collaborator

Kathmandu Medical College and Teaching Hospital

Collaborator

Source ClinicalTrials.gov

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