CTRI Number |
CTRI/2017/08/009387 [Registered on: 17/08/2017] Trial Registered Retrospectively |
Last Modified On: |
10/01/2019 |
Post Graduate Thesis |
No |
Type of Trial |
Interventional |
Type of Study
Modification(s)
|
Preventive Screening Process of Care Changes |
Study Design |
Other |
Public Title of Study
|
Implementation of a mobile technology supported cardiovascular disease prevention program in Indonesia and North India. |
Scientific Title of Study
|
SMARThealth Extend: Implementation of the SMARThealth program in Indonesia and North India |
Trial Acronym |
SMARThealth Extend |
Secondary IDs if Any
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Anushka Patel |
Designation |
Chief Scientist |
Affiliation |
George Institute for Global Health India |
Address |
The George Institute for Global Health | INDIA
311-312, Third Floor, Elegance Tower
Plot No. 8, Jasola District Centre
New Delhi 110025 | India
New Delhi DELHI 110025 India |
Phone |
|
Fax |
|
Email |
apatel@georgeinstitute.org |
|
Details of Contact Person Scientific Query
|
Name |
Dr D Praveen |
Designation |
Program Head, Primary Health Care Research |
Affiliation |
George Institute for Global Health India |
Address |
The George Institute for Global Health India; Unit No. 301, Second Floor, ANR Center, Road No.1, Banjara Hills, Hyderabad-500034, Telangana, India
Hyderabad ANDHRA PRADESH 500034 India |
Phone |
914030994444 |
Fax |
914030994400 |
Email |
dpraveen@georgeinstitute.org.in |
|
Details of Contact Person Public Query
|
Name |
Dr Mohan Pushpinder Singh Kohli |
Designation |
Program Manager, Research & Development |
Affiliation |
George Institute for Global Health India |
Address |
George Institute for Global Health, 219-221, Splendor Forum, Plot Number 3, Jasola District Centre, New Delhi – 110025
South DELHI 110025 India |
Phone |
911141588091 |
Fax |
911141588090 |
Email |
mkohli@georgeinstitute.org.in |
|
Source of Monetary or Material Support
|
Birger Stamperdahl ,
CEO & President
Give2Asia
340 Pine Street, Suite 501
San Francisco, CA 94104 |
|
Primary Sponsor
|
Name |
George Institute for Global Health Australia |
Address |
Level 3, 50 Bridge St, Sydney NSW 2000 Australia; Postal Address: PO Box M201, Missenden Rd, NSW 2050 Australia |
Type of Sponsor |
Research institution |
|
Details of Secondary Sponsor
|
|
Countries of Recruitment
|
India Indonesia |
Sites of Study
|
No of Sites = 2 |
Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
Dr Varun Arora |
Pt. B D Sharma Post Graduate Institute of Medical Sciences |
Room No. 409, Department of Community Medicine, Third Floor, PGIMS Building, Behind Director Office Jhajjar HARYANA |
919034961451
dr.feats@gmail.com |
Dr Sujarwoto |
University of Brawijaya |
Faculty of Administrative Science, University of Brawijaya, Malang, Indonesia
|
0628122721219
sujarwoto@ub.ac.id |
|
Details of Ethics Committee
|
No of Ethics Committees= 2 |
Name of Committee |
Approval Status |
Ethical Committee, Faculty of Medicine, University of Brawijaya, Malang, Indonesia |
Approved |
Institutional Ethics Committee, Pt B D Sharma Post Graduate Institute of Medical Sciences,UHS, Rohtak, India |
Approved |
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Healthy Human Volunteers |
CVD risk factors – BP, RBS, weight, height, CVD events, tobacco use, family history, medications- antihypertensives, hypoglycemics, antiplatelet, statins, quality of life & physical activity |
|
Intervention / Comparator Agent
|
Type |
Name |
Details |
Intervention |
SMARThealth Extend |
Screening of high risk factors for CVD and referal for medium and high risk respondents to health system facility. |
Comparator Agent |
Usual care |
In the control arm in Indonesia, the villages will have access to health care as per usual practice without the Cadres and health center doctors/nurses having access to the SMARThealth system. There will be no control arm in India |
|
Inclusion Criteria
|
Age From |
40.00 Year(s) |
Age To |
85.00 Year(s) |
Gender |
Both |
Details |
participants between 40-85 years |
|
ExclusionCriteria |
Details |
Respondents where measurements for blood pressure, height and weight not possible i.e. incapacitated respondents |
|
Method of Generating Random Sequence
Modification(s)
|
Not Applicable |
Method of Concealment
|
Other |
Blinding/Masking
|
Not Applicable |
Primary Outcome
|
Outcome |
TimePoints |
Indonesia: Difference in the change in the proportion from baseline to end-of-study of high risk individuals prescribed appropriate preventive medications between the intervention and control arms.
India: Difference in the proportion of high risk individuals prescribed appropriate preventive medications between the screening phase (identified by ASHA) and end of the study evaluation (among those identified as high risk by ASHA during screening) |
By February 2018 |
|
Secondary Outcome
|
Outcome |
TimePoints |
Indonesia: Diff in the change in the proportion from baseline to end-of-study (EOS) of high risk individuals (HRI) achieving SBP less than 140mmHg between the int and cont arms.
Diff in mean reduction in BP levels between the int and cont arms.
% of HRI correctly referred and followed-up by NPHWs in the intervention arm.
India: % HRI correctly referred by NPHWs to PHC doctors
% HRI receiving follow-up visits by NPHWs
% HRI achieving blood pressure targets |
By February 2018 |
|
Target Sample Size
|
Total Sample Size="23000" Sample Size from India="7000"
Final Enrollment numbers achieved (Total)= "5970"
Final Enrollment numbers achieved (India)="584" |
Phase of Trial
|
N/A |
Date of First Enrollment (India)
|
04/02/2017 |
Date of Study Completion (India) |
31/01/2018 |
Date of First Enrollment (Global) |
04/02/2017 |
Date of Study Completion (Global) |
31/03/2018 |
Estimated Duration of Trial
|
Years="1" Months="3" Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
Recruitment Status of Trial (India) |
Completed |
Publication Details
|
None yet |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
|
Brief Summary: (short description of the primary purpose of
the protocol, including a brief statement of the study hypothesis)
Systematic Medical
Appraisal, Referral and Treatment (SMARThealth) program is a novel primary care
platform to support communities and healthcare providers in the prevention and
management of common NCDs.
The overall SMARThealth
package includes the Smart Tablet with the SMARThealth Application tailored
towards identification of individuals at high risk for CVD and provide
necessary counseling, referral and follow up. It draws on the principles of
“task-sharing†whereby many routine clinical procedures are transferred from
doctors to non-physician healthcare workers (NPHWs) in an effort to increase
access to healthcare and reduce costs. This is facilitated by a suite of
innovative, affordable digital technologies developed to provide evidence-based
decision support to both providers and consumers
The main objective if the SMARThealth
extend project is to demonstrate the extent to which the SMARThealth program
can be rapidly customized and scaled up in health systems that might differ
substantially (from the Indonesian province of East Java and the northern
Indian state of Haryana), both geographically and demographically, from that in
which the program was developed (West Godavari District of Andhra Pradesh).
Non-communicable diseases (NCDs)
are already the leading cause of the disease burden faced by Indonesia and
India. This burden extends from urban areas to many rural regions. In the 2010
Global Burden of Disease Project, stroke, ischemic heart disease, diabetes and
chronic kidney disease (CKD) were ranked number 1, 7, 5, and 11, respectively,
as the causes of premature mortality among all age groups in Indonesia. In
Indonesia, it is estimated that one in five Indonesian adults aged 41-50 years
is at high risk of cardiovascular disease (CVD). This proportion increases
sharply to 70% for those aged 51-60 years. Furthermore, two-thirds of those at
risk are not receiving appropriate treatment. There are marked geographical
disparities, with rural residents much less likely to access CVD care. The
situation is similar for India, where recent data from rural Andhra Pradesh
shows that 18% of the population aged over 40 years has diabetes, and almost
40% of these cases were previously undiagnosed. Overall, almost 17% of the
adult population was found to be at high short-term risk of CVD and the vast
majority of these individuals were not receiving any preventive drug therapy
whatsoever.
The study is to understand the
issues in the rapid customization and scale up of SMARThealth platform in
different geographical populations and health systems. The project would be
implemented in Jhajjhar district, Haryana, India, covering 4 villages with population
coverage of about 20000 and 4 villages in Indonesia with a population coverage
of about 40,000.The data collection would occur in two occasions in each
village – at baseline and at the end of the SMARThealth Extend implementation
period. The intervention would focus on the routine visits by NPHWs to the
households and evaluating those between 40-85 years for symptoms of CVD and
with support of the Clinical Decision Support System (CDSS) counsel, refer and
follow up the high risk individuals. Mixed methods evaluation will be used to
assess feasibility, acceptability, scalability and sustainability. The key
output will be a comprehensive policy-framed report for each country,
describing the program implementation, reliability and evaluation mechanisms
for integration into the health system framework for NCD prevention. |