HomeResearchProjectsImpact, cost-effectiveness, and sustainability of a synergistic, multipronged, customized, low-cost intervention package (IP) to reduce cardiovascular disease (CVD) burden among diverse populations across India (ICMR-CAR)
Impact, cost-effectiveness, and sustainability of a synergistic, multipronged, customized, low-cost intervention package (IP) to reduce cardiovascular disease (CVD) burden among diverse populations across India (ICMR-CAR)
Details
Cardiovascular diseases (CVD) stand as the primary cause of mortality and morbidity globally, particularly burdening low and middle-income countries (LMIC). There are few contemporary implementation research studies assessing multiple customised interventions for CVD prevention in India. No studies evaluate the impact of Non-Physician Health Worker (NPHW) based interventions on hard clinical endpoints for CVD.In our proposed project, we aim to refine multiple evidence-based interventions for CVD and evaluate their effectiveness, implementation research outcomes, and cost-effectiveness.
The study will be done in three main steps – 1. Formative research using Systematic/Rapid Review, Mixed methods study and a qualitative study. The intervention components will be then prioritized using Delphi process and will be locally customised. 2. The IP will be evaluated through a cluster RCT for effectiveness, implementation research outcomes and cost effectiveness. 3. In this step, we will disseminate the findings and learnings of the study through symposias and we will conduct effective policy dialogues with key stakeholders.
Sample size – 1690
ICMR-CAR Project -Co-Investigator's List
Dr Rajnish Joshi-AIIMS, Bhopal
Dr Tulika Goswami Mahanta-Assam Medical College, Assam
Dr Sitanshu Sekhar Kar-JIPMER, Puducherry
Dr B N Mahanta-Lakhimpur Medical College, Assam
Dr Melvin George-SRM Medical College, Chennai
Dr. Tinku Thomas-St Johns Medical College, Bangalore
Dr Jeemon Panniyammakal-Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum
Dr. Harikrishnan S-Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum
Dr Farah Fathima-St Johns Medical College, Bangalore
Dr Soumya Umesh-St Johns Medical College, Bangalore
Dr. Deepak Kamath-St Johns Medical College, Bangalore
Dr. Deepa S-St Johns Research Institute, Bangalore
Year 1:
Systematic review:
Mixed method systematic reviewincluded randomized and non-randomized controlled trials, before-and-after studies, health system process evaluations, and qualitative studies.
Team of 10 researchers screened 12,492 records from four databases narrowing down to 7,676 relevant records.
After assessing 471 full-text reports, 246 studies were included.
The review categorized articles into five key types: NPHW (43.4%), mHealth (32.9%), FDC (12.6%), Policy/Health System/Referral (8.5%), and Peer Mentor (7%).
Data extraction and review was completed for all 246 articles, and tables along with summary is completed for FDC and NPHW articles.
Cross sectional study:
The study was conducted at 33 medical colleges across 23 states in India, including 6200 participants from the hospital and their rural and urban outreach centres.
Participants included high-risk patients aged >40, caregivers, healthcare providers, and administrators.
Eligibility covered primary and secondary prevention for CVD patients.
Data collection involved surveys on socio-demographics, health system barriers, medication adherence, and prescription patterns, along with healthcare provider knowledge and barriers to adopting evidence-based treatments.
Administrators were surveyed on the availability of medicines and rational FDCs, while health facility surveys assessed readiness for NCD services.
In the cross-sectional study, conducted across 33 sites in 23 states, recruitment as on 1st Sept 2025 includes 4,970 patients (124%), 1,704 caregivers (142%), 668 healthcare providers (111%), and 156 policymakers (78%), resulting in a total recruitment of 7498 participants (123%).
Qualitative study:
We are conducting in-depth interviews and focus group discussions (FGD) at selected intervention sites.
We are interviewing 4 physicians (3 primary care, 1 cardiologist) and 1 nurse at 4 intervention centers (n = 20) as the first step.
This is followed by 3 FGDs, each comprising 6 healthcare providers, including at least 4 physicians (3 primary care, 1 cardiology) and 2 NPHWs (n = 18).
Data collection is ongoing until information saturation is achieved.
In the qualitative study, we have completed 53 out of 56 interviews (95%), with transcripts and coding have been completed.
Delphi:
A two-step Delphi procedure was conducted in December 2024.
A 44-item questionnaire was developed based on interim analysis from systematic review, cross sectional study and qualitative study.
Experts for Delphi step 1, included members from the steering and advisory committees and from previous collaborations.
A total of 123 experts were invited to complete the questionnaire online and 78 (63%) experts completed it.
51 experts were selected from Delphi step 1 based on region, specialty, and viewpoints. Invitations were sent to 51 experts, 24 agreed to participate, and 23 attended the online Delphi step 2.
Meetings:
ICMR-CCC meeting on 5 Aug 2024: for formative phase, mHealth for NCDs, and funding.
Two Collaborators meetings (Jan & Feb 2024) for proposal, roles, and timelines.
Eight RCC meetings for site training & planning.
A 16-member Steering Committee was formed in Feb 2024 and have met thrice; reviewed the formative phase, and planned future steps.
The Advisory Committee was formed in Jun 2024 with eight experts; met twice to discuss eligibility, training, intervention fidelity, and strategic implementation.
Additionally, 20 meetings of coordinators from RCC (CRCC) meetings were held, focusing on study updates, NPHW training, and qualitative research progress.
ENABLE cRCT:
The cRCT sites are randomised & interventions are finalised based on formative research.
The Training of Trainers (ToT) was conducted on 23 to 25 Jan 2025.
A one-week National investigators, coordinators and NPHW’s training (NICoNT) for both control and intervention cluster was held in March. NICoNT was conducted from 24 to 29 March 2025 with 85 participants.
Intervention Tools: NPHW intervention tools, including flipcharts, NPHW training manual, pocket manual, medication reference cards and patient diaries, have been finalized and printed.
Administrative: First ICMR project review committee meeting was held in New Delhi. Dr Denis Xavier and Dr Deepak Kamath attended the meeting and presented the progress of project.
Received funds for year 2.
Year 2 plan:
Recruitment of patients in control and intervention arm
Quality control reports to clusters for the resolution of queries
On-site monitoring visit by RCC or CCC.
Review the follow-up visit data from the RCC or CCC online.
Refresher training of intervention clusters by RCCs
Weekly calls with CRCC to review cluster performances.
Periodic calls with RCC for key issues and best practices
Training and evaluation of additional NPHW at the intervention cluster by RCC
Steering Committee and Advisory Committee meetings