CTRI/2026/01/100602 [Registered on: 08/01/2026] Trial Registered Prospectively
Last Modified On:
07/01/2026
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Preventive Behavioral
Study Design
Cluster Randomized Trial
Public Title of Study
Detection and management of risk factors for heart disease among elderly using digital tools
Scientific Title of Study
Integrated, co-developed intervention for detection and management of cardiometabolic risk factors in older Indians (CARDIO-India)
Trial Acronym
CARDIO-India
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
Affiliation
Centre for Chronic Disease Control
Address
C1/52, 2nd Floor,
Safdarjung Development Area,
New Delhi, India
New Delhi DELHI 110016 India
Phone
9810118696
Fax
Email
dprabhakaran@ccdcindia.org
Details of Contact Person Scientific Query
Name
Prof Sailesh Mohan
Designation
Deputy Director Head CVD Epidemiology
Affiliation
Centre for Chronic Disease Control
Address
C1/52, 2nd Floor,
Safdarjung Development Area,
New Delhi, India
New Delhi DELHI 110016 India
Phone
9650335597
Fax
Email
smohan@ccdcindia.org
Details of Contact Person Public Query
Name
Prof Sailesh Mohan
Designation
Deputy Director Head CVD Epidemiology
Affiliation
Centre for Chronic Disease Control
Address
C1/52, 2nd Floor,
Safdarjung Development Area,
New Delhi, India
New Delhi DELHI 110016 India
Phone
9650335597
Fax
Email
smohan@ccdcindia.org
Source of Monetary or Material Support
National Institute for Health and Care Research (NIHR),
39 Victoria Street,
London SW1H 0EU,
United Kingdom.
Primary Sponsor
Name
Centre for Chronic Disease Control
Address
C1/52, 2nd Floor,
Safdarjung Development Area,
New Delhi, India – 110016
Type of Sponsor
Research institution
Details of Secondary Sponsor
Name
Address
NIL
Countries of Recruitment
India
Sites of Study
No of Sites = 12
Name of Principal
Investigator
Name of Site
Site Address
Phone/Fax/Email
Yetendra Yadav Vonteru
Andhra Pradesh & Telangana MHU
HelpAge India, H. No: 12-13-329, Street No. 10, Opposite Sri Chaitanya Junior College, Tarnaka, Secunderabad-500017, Telangana Visakhapatnam ANDHRA PRADESH
9440773535
VY.Yadav@helpageindia.org
Alok Kumar Verma
Bihar and Jharkhand MHU
HelpAge India, House No. 179/D, Patliputra Colony, Patna - 800013 Patna BIHAR
HelpAge India, 53F/181, Rajpur Road, Opposite St. Joseph Academy Dehradun 248001 Dehradun UTTARANCHAL
8510832599
Chaitanya.Upadhyay@helpageindia.org
Details of Ethics Committee
No of Ethics Committees= 5
Name of Committee
Approval Status
CCDC IEC
Approved
CCDC IEC
Approved
CCDC IEC
Approved
IEC AIIMS
Approved
Institute for Financial Management and Research
Approved
Regulatory Clearance Status from DCGI
Status
Not Applicable
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: I00-I99||Diseases of the circulatory system,
Intervention / Comparator Agent
Type
Name
Details
Intervention
CARDIO-India programme
The CARDIO-India programme is a co-created, technology-enabled, community and primary health system-based intervention aimed at improving early detection, treatment, and management of metabolic risk factors for cardiovascular disease among older adults (60 years and above). It comprises:
(i) a digital health platform integrating an electronic Clinical Decision Support System (CDSS), electronic health record (EHR), assisted telemedicine, and validated point-of-care diagnostic devices; and
(ii) a patient-facing mobile application (or in-person visits/text messaging/IVRS for older adults without smartphone access) to support self-management, adherence, and continuity of care.
The intervention will be delivered through Mobile Healthcare Units (MHUs) operated by HelpAge India, with healthcare staff trained in the use of CDSS and telemedicine tools
Comparator Agent
Usual care
The control arm will receive usual care currently provided through the Mobile Healthcare Units (MHUs), which includes medical consultations, dispensing of medicines, health education, and referrals as needed for the management of metabolic risk factors for cardiovascular disease, without the CARDIO-India digital components
Inclusion Criteria
Age From
60.00 Year(s)
Age To
99.00 Year(s)
Gender
Both
Details
Participants will include older adults aged 60 years and above who have been diagnosed with hypertension (systolic blood pressure more than or equal to 140 mmHg or diastolic blood pressure more than or equal to 90 mmHg, with or without antihypertensive treatment) and are accessing healthcare services for hypertension management from the Mobile Healthcare Units (MHUs) operated by HelpAge India.
ExclusionCriteria
Details
Participants who are unable to provide informed consent and those with serious or terminal illnesses that would impede their ability to participate in study procedures or follow-up assessments, will be excluded from the study
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Open Label
Primary Outcome
Outcome
TimePoints
Difference in mean delta change of SBP between both arms
Primary outcome will be measured at baseline, 12-month and 24-month intervals
Secondary Outcome
Outcome
TimePoints
Mean change in the physical component score as measured by SF-12
Measured at baseline, 12-month and 24-month follow-up periods
Mean change in the cardiovascular disease (CVD) risk assessed by the WHO CVD Risk Chart adapted for the Southeast Asia Region
Measured at baseline, 12-month and 24-month follow-up periods
Change in proportion of older people achieving hypertension control
Measured at baseline, 12-month and 24-month follow-up periods
Change in proportion of older people achieving glycaemic control
Measured at baseline, 12-month and 24-month follow-up periods
Change in proportion of older people achieving hyperlipidaemia (total cholesterol less than 190mg/dl) control
Measured at baseline, 12-month and 24-month follow-up periods
Change in proportion of older people with overweight/obesity
Measured at baseline, 12-month and 24-month follow-up periods
Mean change in self-management (self-efficacy, adherence to treatment recommendations, changes in tobacco use/smoking, physical activity levels, alcohol use)
Measured at baseline, 12-month and 24-month follow-up periods
Change in proportion of older people with depression assessed by PHQ-9
Measured at baseline, 12-month and 24-month follow-up periods
Mean change in the Quality of Life (QoL) assessed by EuroQol 5 dimensions (EQ-5D) 3-level version
Measured at baseline, 12-month and 24-month follow-up periods
Outcomes related to the care processes (Change in proportion of medication use, healthcare access and utilisation, hospitalisations)
Measured at baseline, 12-month and 24-month follow-up periods
Mean change in multidimensional indices of function measured by the WHO Disability Assessment Schedule
Measured at baseline, 12-month and 24-month follow-up periods
Mean change in the fried Index and activities of daily living
Measured at baseline, 12-month and 24-month follow-up periods
Target Sample Size
Total Sample Size="1824" Sample Size from India="1824" 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)
01/02/2027
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="2" 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 CARDIO-India study is a cluster randomized controlled trial designed to evaluate the effectiveness and cost-effectiveness of a co-created, technology-enabled, community and primary health system-based intervention to improve early detection, treatment, and management of metabolic risk factors for cardiovascular disease (CVD) among older adults (60 years and above) in India. The intervention (CARDIO-India programme) integrates an electronic Clinical Decision Support System (CDSS), electronic health records, assisted telemedicine, and validated point-of-care testing devices with a patient-facing mobile application (or in-person visits/text messaging/IVRS for those without smartphone access) to enhance self-management and continuity of care. The trial will be implemented through Mobile Healthcare Units (MHUs) operated by HelpAge India in five states. MHUs will be randomized (1:1) into intervention and control arms, with control sites providing usual care. The primary outcome is the change in mean systolic blood pressure at 24 months, with secondary outcomes including CVD risk, metabolic control indicators, quality of life, functional status, self-management, and mortality.