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
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 design
Treatments tested in this trial
- Electronic Decision Support System (EDSS)
- Assisted telemedicine
- Patient facing mobile app and Community champions (Care coordinators)
Treatment groups
Sponsors and collaborators
Centre for Chronic Disease Control, India
Lead sponsor
All India Institute of Medical Sciences, Jodhpur
Collaborator
Kathmandu Medical College and Teaching Hospital
Collaborator