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Clinical Trials/CTRI/2025/03/083634
CTRI/2025/03/083634RecruitingPhase 1

RAHAT- Smart Village Initiative: Addressing inequities and improving access to quality primary healthcare in rural India by harnessing integrated digital health solutions.

Indian Council for Medical Research6 sites in 1 country2,000 target enrollmentStarted: April 7, 2025Last updated:

Trial Snapshot

Phase
Phase 1
Status
Recruiting
Sponsor
Enrollment
2,000
Locations
6
Primary Endpoint
Improved access to healthcare, digital health literacy, and compliance with care.

Study Overview

Brief Summary

The "Smart Village Initiative" project, is designed to address the healthcare challenges faced by the rural population in India. The driving force behind this initiative is the recognition of the public health challenges posed by the dual burden of disease in rural areas, encompassing pre-transitional diseasesand the growing chronic disease burden along with emerging challenges of environmental pollution, climate change and new/re-emerging infections. High quality research remains the cornerstone for identifying suitable solutions to these priority public health challenges. Additionally, access to timely, affordable, and appropriate health care services remains a critical gap in rural areas.

To tackle these challenges and gaps in health service delivery, the proposal will focus on Building research capacity and a model research infrastructure at the level of linked medical colleges (Multidisciplinary Research Units (MRUs) in government medical colleges and Research Divisions (RDs) at private medical colleges) and Bringing in a paradigm shift in health service delivery, leveraging digital advancements to bridge the gap between knowledge and implementation ( the Know-do gap), ultimately improving population health and wellbeing.

The proposed interventions are aimed at enhancing primary care facilities for both non communicable disease and ante-natal care, implementing digital referral pathways, empowering communities, and building institutional research infrastructure, research capacity, and implementation capabilities, improving environmental resilience of the facilities.

The first year will focus on preparatory activities and an extensive needs assessment at the institutional, facility, and community levels. Training programmes and certification initiatives for healthcare professionals will be integral components in this year, emphasizing the importance of research methods, health system strengthening and implementation science, climate resilience and digital health and co-designing the intervention. The subsequent years will focus on and rolling it out in a vanguard mode in all six study sites. The third and fourth year will focus on extending the initiative to full-scale implementation of interventions, incorporating the successful interventions and, change in interventions based on the lessons learnt from the vanguard phase. Concurrent monitoring, refresher trainings, and data collection are emphasized during this phase. The final year will involve the completion of implementation, project evaluation, and sustainability planning for a replicable model towards scale-up. The evaluation will include pre- and post-implementation population and health facility surveys, RE-AIM assessments, incorporating parameters of PROGRESS-Plus framework[1], ensuring a comprehensive understanding of the project’s likely impact.

Anticipated outcomes will include improved access, reduced health disparities, enhanced health outcomes, and the establishment of a scalable and sustainable rural intervention model. The project envisions benefits beyond its immediate scope, including the creation of robust research platforms for future research, nationwide expansion, and serving as a potential model for other lower middle-income countries facing similar health challenges.

Study Design

Study Type
Interventional

Eligibility Criteria

Ages
18.00 Year(s) to 99.00 Year(s) (—)
Sex
All

Inclusion Criteria

  • Institute Level- IDI and FGD- Leadership and Faculty & UG and PG students.
  • MRU situational analysis- Nodal person.
  • Facility Level- Facility Assessment- Nodal person.
  • IDI- Healthcare professionals working for at least 3 months.
  • ANC observation-All pregnant women visiting the RHTC aged 18 years or above.
  • Patient exit interview- patients more than or equal to18 years visiting OPD requiring specialist care Community Level-Household enumeration- All households in identified village.
  • Household survey- Individuals more than or equal to 30 years of age living in selected study area.
  • IDI and FGD- Representative member of the village.

Exclusion Criteria

  • Facility-Level- Facility ANC observation Women coming to RHTC for a non-routine ANC visit (for example, to get a laboratory investigation, or to collect a report or her medicine Community- Level-Community household questionnaire Individuals under 30 years of age Pregnant women as they will be covered under ANC observation at the facility Household members who do not currently reside in the household Members who cannot provide consent due to physical or cognitive disability.

Outcomes

Primary Outcomes

Improved access to healthcare, digital health literacy, and compliance with care.

Time Frame: Formative/Baseline, endline after 5 years.

Secondary Outcomes

  • Improved research capacity, reduced health disparities, and better NCD management.(Formative/Baseline, endline after 5 years.)

Investigators

Sponsor
Indian Council for Medical Research
Sponsor Class
Research institution
Responsible Party
Principal Investigator
Principal Investigator

Prof. Dorairaj Prabhakaran

Centre for Chronic Disease Control (CCDC)

Study Sites (6)

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