CTRI/2025/05/086982 [Registered on: 15/05/2025] Trial Registered Prospectively
Last Modified On:
15/05/2025
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Preventive Screening Process of Care Changes
Study Design
Other
Public Title of Study
Use of Digital Technology to Improve Care for Diabetes and High Blood Pressure in Indian Public Health System
Scientific Title of Study
An Implementation Research to Strengthen DIGItal technologies for
optimizing the Continuum of CARE for Diabetes and Hypertension
Management in the Public Healthcare System in India DIGICARE
Trial Acronym
DIGI-CARE
Secondary IDs if Any
Secondary ID
Identifier
NIL
NIL
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Roopa Shivashankar
Designation
Scientist E
Affiliation
ICMR
Address
Room No 204
First Floor
ICMR Headquarters
Ansari Nagar New Delhi New Delhi DELHI 110029 India
Phone
9312065025
Fax
Email
shivashankar.r@icmr.gov.in
Details of Contact Person Scientific Query
Name
Dr Roopa Shivashankar
Designation
Scientist E
Affiliation
ICMR
Address
Room No 204
First Floor
ICMR Headquarters
Ansari Nagar New Delhi New Delhi DELHI 110029 India
Phone
9312065025
Fax
Email
shivashankar.r@icmr.gov.in
Details of Contact Person Public Query
Name
Prof Jaideep Chanayil Menon
Designation
Professor and Head
Affiliation
Amrita Institute of Medical Sciences
Address
Department of Preventive Cardiology,
Ponekkara Rd,Edappally, Kochi, Ernakulam, Kerala
Ernakulam KERALA 682041 India
Phone
9895122099
Fax
Email
menon7jc@gmail.com
Source of Monetary or Material Support
ICMR, New Delhi
Primary Sponsor
Name
ICMR HQs
Address
Indian Council of Medical Research, V. Ramalingaswami Bhawan, P.O. Box No. 4911, Ansari Nagar, New Delhi - 110029, India
Type of Sponsor
Government funding agency
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
Dr Purabi Phukan
All India Institute of Medical Sciences (AIIMS)
Department of CFM, AIIMS Changsari, Guwahati, 781101 Kamrup ASSAM
9916125195
purabiphukan@aiimsguwahati.ac.in
Prof Jaideep Chanayil Menon
Amrita Institute of Medical Science (AIMS)
Preventive Cardiology and Population Health Sciences Unit of Public Health Cardiology, AIMS,
Ponekkara Rd, P. O, Edappally, Kochi, Ernakulam, Kerala 682041 Ernakulam KERALA
9895122099
menon7jc@gmail.com
Dr Sailesh Mohan
Centre for Chronic Disease Control (CCDC)
CVD Epidemiology,
,CCDC
C-1/52, 2ND FL, Safdarjung Development Area, New Delhi, Delhi 110016 Solan HIMACHAL PRADESH
9650335597
smohan@ccdcindia.org
Dr Ramesh Kumar Huda
ICMR- National Institute for Implementation Research on Non-Communicable disease (ICMR-NIIRNCD)
ICMR-NIIRNCD,
New Pali Road
Jodhpur- 342005 Barmer RAJASTHAN
9602755600
rameshk.h@icmr.gov.in
Dr Subitha Lakshminarayanan
Jawaharlal Institute of Postgraduate Medical Education and Research (JIPMER)
Department of PSM,
JIPMER, Pondicherry, 605006 Pondicherry PONDICHERRY
8489216058
subitha.l@gmail.com
Dr Devarsetty Praveen
The George Institute for Global Health (TGI)
Faculty of Medicine,
TGI
Shangrilla Plaza # 401, Banjara Hills, Road No 2,
Hyderabad, 500034
Telangana
Surguja CHHATTISGARH
Hybrid training modules will be developed based on the identified gaps
from the desk review and formative assessment focusing on 3 core
modules (digital technology competence, user workflows on the
application and data use). Following this, a Training of Trainers (ToT) model will be employed,
alongside online training programs for all healthcare providers.Additional modules on responsible use of DHIs in terms of data privacy,
confidentiality and other aspects will be developed based on the need.
Various online training platforms like SAKSHAM, SASHAKT, NPTEL, and
SWAYAM will be explored to enhance learning opportunities for
healthcare providers, particularly focusing on modules for frontline health
workers, including short videos or eLearning on troubleshooting,
potentially shareable via WhatsApp.
Intervention
Creating Digital
support team
Setting up support groups at the health facility level will help in
removing obstacles in digital adaptation, achieving targets, and
further refining strategies based on regular performance review.
Enable local query resolving through local digital support or
escalate to the Technical Support Units (TSUs) for addressing
portal issues and retrain if needed.
District-level support groups for troubleshooting will provide
technical assistance and support to the stakeholders involved in a
timely manner and help improve data sharing from downstream
and to upstream stakeholders.
Strengthening of ABHA enrolment in the facilities will be
addressed by the local support teams based on the site-specific
challenges.
Intervention
Creating Digitally
empowered
champions
It focuses on fostering a culture of digitalization among healthcare
workers at all levels. The key steps include
Motivational campaigns led by district authorities to emphasize the
urgency of digitalization, highlighting its benefits for patient outcomes,
operational efficiency, and the role of data quality. These campaigns
will engage frontline workers, such as ASHAs, ANMs, CHOs, and MOs,
aligning with their responsibilities.
To build trust in digital data, the focus will be on addressing resistance
to digitization by demonstrating how digital systems reduce
administrative burdens, improve care, and ensure data privacy and
security.
Digital champions will be identified based on their engagement with
DHIs, positive attitude toward digitalization, and consistent use of tools
like the National NCD portal and eSanjeevani. These champions will
mentor peers, facilitate learning, and create local support networks.
Continuous feedback loops between champions and program
managers will enable ongoing improvements, while a recognition and
rewards system will sustain motivation. District-wide networks will
scale the champions’ role and promote sharing of best practices.
Intervention
Enabling Digital
driven program
management
Dashboard Utilization for Healthcare Workers: Healthcare workers,
including ANMs, CHOs, and Medical Officers, will be trained to use
digital dashboards actively. This will help monitor patient data, service
coverage, and care indicators. Regular dashboard use will guide
healthcare workers in prioritizing patient follow-ups, screenings, and
interventions based on data-driven work plans.
Comparator Agent
NOT APPLICABLE
NOT APPLICABLE
Intervention
Redesigning
clinical workflows
for NCD care
A detailed workflow assessment will be conducted to understand the user
workflow to identify specific barriers and opportunities for training by
closely examining how healthcare providers interact with digital tools and
their surrounding environment. Based on the findings from the workflow
assessment conducted during the formative phase, specific workflow
changes will be implemented Task reorganisation and optimization of workflows for digital
adaptation (screening, NCD management using the application)
to promote use of DHI Optimizing data management by transitioning from a dual paper
electronic system to electronic program documentation and
reporting- This will be done through discussions with program
managers and other supervisory levels at HWCs to streamline
workflows and avoid duplicate paper entries. Optimize assisted telemedicine services through staff planning
Intervention
Strengthening
digital
infrastructure &
NCD care services
To address the identified gaps in terms of technology infrastructure and
enhance the overall NCD management targeted advocacy efforts will be
undertaken with the district health office which include
Advocacy to improve IT infrastructure administration and IT technical support systems
Allocation of necessary manpower material time for
telemedicine service
Advocacy for provision of essential NCD diagnostics and
treatment
Inclusion Criteria
Age From
30.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
Adults above 30 years
Patients with Diabetes and/or Hypertension
ExclusionCriteria
Details
Below 30 years
Healthy population
Method of Generating Random Sequence
Not Applicable
Method of Concealment
Not Applicable
Blinding/Masking
Not Applicable
Primary Outcome
Outcome
TimePoints
In depth understanding of implementation status of digital health technologies in the NP-NCD
Identify context specific enablers and barriers to effective implementation of technologies
Stakeholder mapping
Scope for refining Theory of Change
After Formative phase and Baseline
Secondary Outcome
Outcome
TimePoints
Development of base implementation model using "Plan-Do-Study-Act" cycle
10-16 months co-design and model optimization
Target Sample Size
Total Sample Size="258" Sample Size from India="258" Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials" Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials"
Phase of Trial
N/A
Date of First Enrollment (India)
26/05/2025
Date of Study Completion (India)
Applicable only for Completed/Terminated trials
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Applicable only for Completed/Terminated trials
Estimated Duration of Trial
Years="3" Months="0" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Not Yet Recruiting
Publication Details
N/A
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
The cascade of care for non-communicable diseases (NCD) such as diabetes and hypertension management involve a series of interlinked functions of enrolment, risk assessment, screening, diagnosis and treatment, follow-up and referral. Ensuring the continuum of care from sub-centre level up to district hospitals with up and down referrals as required, poses a great challenge to the public healthcare system. These could be due to several factors like the huge burden of the condition,disease requirements of continuous monitoring and follow-up, insufficient public awareness about the need for a continuum of care, and other prioritized demands of the health system. Digital health tools, including telemedicine and mobile health apps offer the potential to bridge gaps in care by providing real-time data, facilitating remote consultations, and enabling continuous patient monitoring. Currently, there are several digital health solutions within the public healthcare system, but disconcertingly their uptake and utilisation are sub-optimal. Poor digital infrastructure, technical issues, inadequate training, and suboptimal clinic workflows are commonly cited challenges.Behavioral resistance to digitization and continued use of paper-based records further hinders adoption. Given this context, better integration of existing digital health solutions and increased uptake and utilisation can likely advance care of major NCDs, enhance disease monitoring, improve patient engagement, and optimize resource allocation, leading ultimately to better health outcomes.In the National Program for Non communicable Diseases (NP-NCD), several digital applications and services aim to achieve better screening, compliance, and control of NCDs and improve access to healthcare. The national NCD portal (or equivalent alternative systems of a state) forms the backbone of digital health interventions for NCD care delivery in the public healthcare system, along with the eSanjeevani telemedicine platform (or similar alternative in states). For widespread rollout of thesedigital technologies in the NP-NCD, the health system faces several challenges like poor digital infrastructure, inadequacy in training, technical and usability challenges and lack of primary user motivation. To address the aforementioned, in this multi-site multi-institutional collaborative project, we aim to develop and implement a digital health system model that would enable increased adoption and effective use of existing digital health interventions under the NP-NCD. The study will be implemented in one district of each of the following states: Rajasthan (Barmer), Assam (Kamrup), Chhattisgarh (Suguja), Puducherry (Puducherry), Himachal Pradesh (Solan), and Kerala (Ernakulam). The proposed implementation strategies will be directed towards strengthening the digital infrastructure within the district, building capacity of healthcare providers for digital competence, redesigning NCD workflows and task reorganisation for digital adaptation, developing motivational strategies to improve digital technology adoption and utilisation, and enhancing data quality and data use for monitoring. The intervention development will be guided by a theory of change and this will be modified as required based on the findings from the formative phase. In this project spanning three years, the initial formative phase (9 months) will include setting up a centralized technical and research support team, describing the existing digital technologies in the NP-NCD program, and understanding enablers and challenges in their adoption and use. We will build on the barrier analysis work already conducted by the teams and use these insights to inform co-production workshops with district health authorities, healthcare providers and community members in the following co-production phase (7 months). This phase will involve the co-designing of the interventions to increase adoption among the stakeholders. A base model of the proposed interventions will be developed, and implemented in two blocks for a period of 3 months. Model iterations will be conducted using the “Plan-Do-Study- Act” (PDSA) cycles based on feedback and periodic performance assessments. An ‘optimised model’ will be ready after 2-3 PDSA cycles for implementation in the final intervention implementation and evaluation phase. In this phase, the implementation strategies will be scaled up across the study districts for a period of 18 months and a concurrent evaluation will be undertaken using a pre-post quasi-experimental design. Facilities will be assessed using checklists, and healthcare provider knowledge and practice changes will be evaluated through assessments and interviews. Patient exit interviews and dashboard review for care indicators will also be done. In the last 2 months, findings and insights will be shared with relevant stakeholders to ensure alignment to the program. Ongoing monitoring and feedback mechanisms will be established to sustain and evolve improvements.