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CTRI Number  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 
9959777623

dpraveen@georgeinstitute.org.in 
 
Details of Ethics Committee  
No of Ethics Committees= 6  
Name of Committee  Approval Status 
AIIMS Guwahati  Approved 
Ethics Committee of Amrita School of Medicine   Approved 
George Institute of Global Health  Approved 
ICMR NIIRNCD Institutional Ethical Committe  Approved 
Institute Ethics Committee- CCDC  Approved 
INSTITUTIONAL ETHICS COMMITTEE - Interventional Studies JIPMER Puducherry  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I10||Essential (primary) hypertension, (2) ICD-10 Condition: E115||Type 2 diabetes mellitus with circulatory complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Capacity building for digital competency   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.


 
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