CTRI/2025/03/083634 [Registered on: 28/03/2025] Trial Registered Prospectively
Last Modified On:
13/02/2026
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Diagnostic Preventive Screening Process of Care Changes Behavioral
Study Design
Single Arm Study
Public Title of Study
ICMR Centre for Advanced Research for Rural Healthcare Transformation.
Scientific Title of Study
RAHAT- Smart Village Initiative: Addressing inequities and improving access to quality primary healthcare in rural India by harnessing integrated digital health solutions.
Trial Acronym
CAR RAHAT
Secondary IDs if Any
Secondary ID
Identifier
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Prof. Dorairaj Prabhakaran
Designation
Executive Director, Centre for Chronic Disease Control (CCDC)
Affiliation
Centre for Chronic Disease Control (CCDC)
Address
C-1/52, 2ND FL, Room-1, Health Systems Department, NCD Division, Safdarjung Development Area, New Delhi C-1/52, 2ND FL, Room-1, Health Systems Department, NCD Division, Safdarjung Development Area, New Delhi New Delhi DELHI 110016 India
Phone
01141618456
Fax
Email
dprabhakaran@ccdcindia.org
Details of Contact Person Scientific Query
Name
Dr Akansha Kumari
Designation
Program Coordinator
Affiliation
Centre for Chronic Disease Control (CCDC)
Address
C-1/52, 2ND FL, Bridge Centre for Digital Health Division Safdarjung Development Area, New Delhi C-1/52, 2ND FL, Bridge Centre for Digital Health Division Safdarjung Development Area, New Delhi New Delhi DELHI 110016 India
Phone
8766280298
Fax
Email
akansha@ccdcindia.org
Details of Contact Person Public Query
Name
Dr Akansha Kumari
Designation
Program Coordinator
Affiliation
Centre for Chronic Disease Control (CCDC)
Address
C-1/52, 2ND FL, Bridge Centre for Digital Health Division Safdarjung Development Area, New Delhi C-1/52, 2ND FL, Bridge Centre for Digital Health Division Safdarjung Development Area, New Delhi New Delhi DELHI 110016 India
Phone
8766280298
Fax
Email
akansha@ccdcindia.org
Source of Monetary or Material Support
Indian Council of Medical Research · V. Ramalingaswami Bhawan, P.O. Box No. 4911 · Ansari Nagar, New Delhi - 110029, India
Primary Sponsor
Name
Indian Council for Medical Research
Address
V. Ramalingaswami Bhawan, P.O. Box No. 4911
Ansari Nagar, New Delhi - 110029, India
Type of Sponsor
Research institution
Details of Secondary Sponsor
Name
Address
NIL
NIL
Countries of Recruitment
India
Sites of Study
No of Sites = 6
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Prof Dr Subrata Baidya
Agartala Government Medical College
Community Medicine Department, 2nd Floor, Agartala Government Medical College & G.B. Pant Hospital, Kunjaban, Agartala, West Tripura, Tripura, PIN code 799006, India West Tripura TRIPURA
9436122899
drsubratabaidya@gmail.com
Dr Gajanan D Velhal
B.K.L. Walawalkar Rural Medical College
First Floor, Department of Community Medicine, BKLWRMC, Kasarwadi, A/p Sawarde, Tal - Chiplun, Maharashtra 415606, India Ratnagiri MAHARASHTRA
9920446233
vgajanan@rediffmail.com
Dr Deepshikha Kamra
Christian Medical College & Hospital
First Floor, Department of Community Medicine, CMC Campus, Ludhiana, Punjab 141008, India Ludhiana PUNJAB
9463034958
deepshikhakamra@gmail.com
Prof Dr E Theranirajan
Madras Medical College
Dean Chamber, RGGGH, Post Office, Poonamallee High Road, 3, Grand Southern Trunk Rd, near Park Town, Near Chennai Central, Park Town, Chennai, Tamil Nadu 600003, India Chennai TAMIL NADU
9003517417
theranirajan1966@gmail.com;
Dr Sudha Ramalingam
PSG Institute of Medical Sciences & Research
Dean chamber, first floor, tower 1, Avinashi Rd, Peelamedu, Coimbatore, Tamil Nadu 641004, India Coimbatore TAMIL NADU
9894429646
drsudhapsg@gmail.com
Dr Abhay S Nirgude
Yenepoya Medical College
YMC Academic Building, Ground Floor, Yenepoya University Campus, Deralakatte, Karnataka 575018, India Dakshina Kannada KARNATAKA
7259715709
deanymc@yenepoya.edu.in
Details of Ethics Committee
No of Ethics Committees= 6
Name of Committee
Approval Status
IEC, BKLWH , B.K.L. Walawalkar Hospital Dignostic and Research
Approved
Institutional Ethics Committee
Approved
Institutional Ethics Committee of Agartala Govt. Medical College
Approved
Institutional Ethics Committee of Madras Medical College (IEC, MMC)
Approved
Institutional Human Ethics Committee (IHEC)
Approved
Yenepoya Ethics Committee 1
Approved
Regulatory Clearance Status from DCGI
Status
Not Applicable
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: I10-I16||Hypertensive diseases, (2) ICD-10 Condition: O00-O9A||Pregnancy, childbirth and the puerperium, (3) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications,
Intervention / Comparator Agent
Type
Name
Details
Intervention
1. Institutional Level Interventions
Strengthening medical research units (MRUs) & RDs in medical colleges.
Capacity building for medical students and faculty through training programs in:
Research methods,
Health system strengthening,
Digital health
Environmental health and sustainability.
Short courses for healthcare professionals.
Developing research infrastructure and research capacity at medical institutions.
Training of Trainers (ToT) workshops to create institutional expertise in research and healthcare delivery. The duration is from December 2025 to July 2028.
Intervention
2. Facility-Level Interventions
Assisted Telemedicine Clinics:
Trained healthcare professionals assist in telemedicine consultations.
Digital tools used: handheld ECG devices, digital stethoscopes, point-of-care diagnostic kits, and high-definition remote-controlled cameras.
Electronic Clinical Decision Support Systems (e-CDSS):
Manages chronic diseases like diabetes, hypertension, cardiovascular diseases, and COPD.
mIRA: Supports maternal healthcare by managing gestational diabetes, pregnancy-induced hypertension, and antenatal care.
Electronic Health Records (EHRs):
Facilitates seamless data storage, retrieval, and patient tracking.
Ensures continuity of care and reduces medical errors.
Climate-Resilient Health Facilities:
Recommendations for infrastructure improvement to withstand environmental challenges. The duration is from December 2025 to July 2028.
Intervention
3. Community-Level Interventions
Digital Health Awareness Campaigns:
Educating communities about digital health services and telemedicine.
Improving digital literacy to enhance health-seeking behavior.
Medical Camps and Screening Programs:
Conducting community-based screening for hypertension, diabetes, and maternal health.
Awareness campaigns on disease prevention and health promotion.
Creation of Ayushman Bharat Health Account (ABHA) IDs:
Enabling electronic health records for community members.
Improving health service utilization and follow-ups.
Task-Shifting and Community Engagement:
Training non-physician healthcare workers to support healthcare delivery.
Community participation in healthcare planning and implementation. The duration is from December 2025 to July 2028.
Comparator Agent
Not applicable
Not applicable
Inclusion Criteria
Age From
18.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
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.
ExclusionCriteria
Details
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
Method of Generating Random Sequence
Method of Concealment
Blinding/Masking
Primary Outcome
Outcome
TimePoints
Improved access to healthcare, digital health literacy, and compliance with care.
Formative/Baseline, endline after 5 years.
Secondary Outcome
Outcome
TimePoints
Improved research capacity, reduced health disparities, and better NCD management.
Formative/Baseline, endline after 5 years.
Target Sample Size
Total Sample Size="2000" Sample Size from India="2000" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
What data in particular will be shared? Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
What additional supporting information will be shared? Response - Study Protocol Response - Informed Consent Form
Who will be able to view these files? Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
For what types of analyses will this data be available? Response - To achieve aims in the approved proposal.
By what mechanism will data be made available? Response (Others) - Proposals should be directed to car.rahat@ccdcindia.org- to gain access, data requestors will need to sign a data access agreement.
For how long will this data be available start date provided 02-01-1970 and end date provided 02-01-1970? Response - Beginning 9 months and ending 36 months following article publication.
Any URL or additional information regarding plan/policy for sharing IPD? Additional Information - NIL
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 diseases and 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.