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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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