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CTRI Number  CTRI/2012/07/002762 [Registered on: 04/07/2012] Trial Registered Prospectively
Last Modified On: 22/11/2019
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Process of Care Changes 
Study Design  Cluster Randomized Trial 
Public Title of Study   Simplified cardiovascular management study 
Scientific Title of Study   Simplified Cardiovascular Management (SimCard) Study – A Cluster-Randomized Trial to Evaluate the Effects of a Simplified Cardiovascular Management Program in India 
Trial Acronym  SIMCARD 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Vamadevan S Ajay 
Designation  Research Fellow 
Affiliation  Public Health Foundation of India 
Address  Public Health Foundation of India 4/2, Sirifort Institutional Area, August Kranti Marg, New Delhi - 16

South
DELHI
110016
India 
Phone  91-11-26850117  
Fax  91-11-26850588  
Email  ajay@ccdcindia.org  
 
Details of Contact Person
Scientific Query  
Name  Dr Vamadevan S Ajay 
Designation  Research Fellow 
Affiliation  Public Health Foundation of India 
Address  Public Health Foundation of India 4/2, Sirifort Institutional Area, August Kranti Marg, New Delhi - 16


DELHI
110016
India 
Phone  91-11-26850117  
Fax  91-11-26850588  
Email  ajay@ccdcindia.org  
 
Details of Contact Person
Public Query  
Name  Dr Vamadevan S Ajay 
Designation  Research Fellow 
Affiliation  Public Health Foundation of India 
Address  Public Health Foundation of India 4/2, Sirifort Institutional Area, August Kranti Marg, New Delhi - 16


DELHI
110016
India 
Phone  91-11-26850117  
Fax  91-11-26850588  
Email  ajay@ccdcindia.org  
 
Source of Monetary or Material Support  
National Heart Lung and Blood Institute, USA. 
 
Primary Sponsor  
Name  National Heart Lung and Blood Institute 
Address  NHLBI Office of the Director National Heart, Lung, and Blood Institute Building 31, Room 5A52 31 Center Drive MSC 2486 Bethesda, MD 20892  
Type of Sponsor  Government funding agency 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     China
India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Vamadevan S Ajay  Ballabgarh  Intervention: Primary Health Center (PHC) of 6 villages in Faridabad, Haryana. Control: Primary Health Center (PHC) of 6 village in Faridabad, Haryana.
Faridabad
HARYANA 		 91-11-43421966

ajay@ccdcindia.org 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Public Health Foundation of India (PHFI), New Delhi   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied
Modification(s)  
Health Type  Condition 
Patients  • History of coronary heart disease, ischemic stroke, or hemorrhagic stroke, or Diabetes mellitus, (1) ICD-10 Condition: I63||Cerebral infarction, (2) ICD-10 Condition: I259||Chronic ischemic heart disease, unspecified, (3) ICD-10 Condition: I10||Essential (primary) hypertension, (4) ICD-10 Condition: E118||Type 2 diabetes mellitus with unspecified complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Simplified Cardiovascular management programme  Villages in the control group will continue their usual practices while villages in the intervention group will receive the following intervention lasting one year long. The simplified cardiovascular managementinterventionwill have the following features: 1) target individuals at high risk for CVD for maximal cost-effectiveness; 2) simplify guideline-based CVD prevention and management schemes to suit local situations, emphasizing the importance of patient identification, referral, regular follow-up and a “2+2”model: 2 therapeutic lifestyle recommendations (smoking cessation and salt reduction) plus prescription of 2 effective and low-cost drugs (aspirin and low-dose diuretics); 3) enhance the capacity of local CHWs in CVD prevention and management through systematic training; 4) ensure the effectiveness of training through healthcare system strengthening that integrate township PCPs, EDS, performance feedback to CHWs and performance-based payment; 5) being flexible and adaptive to incorporate insights gained from process evaluation and program implementation; and 6) enlist the help of government officials in implementing the management schemes; we do not anticipate any problem in obtaining such support owing to our rapport in working with them before.  
Comparator Agent  Usual practice  Villages in the control group will continue their usual practices. 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  All participants above the age of 40 years will be approached to participate regardless of gender, ethnic group, denomination, or other factors to assess their cardiovascular risk status.From this group subjects having elevated cardiovascular risk will be eligible for enrollment in study. High cardiovascular risk will be defined as:
• History of coronary heart disease, ischemic stroke, or hemorrhagic stroke, or
• Older age - 40 years or older and having diabetes mellitus, or
• Older age (40 years or more) and systolic blood pressure more than 160 mmHg on two occasions at least one day apart.
 
 
ExclusionCriteria 
Details  The research proposes to study adults at high risk for cardiovascular disease, and excludes adults below the age of 40 years. Additional exclusions are:
• Subjects with cardiovascular diseases complications whom cannot be managed at primary care settings
• Subjects having Malignancy or life-threatening diseases;
• Bed-ridden subjects;
• Currently participating in a clinical trial;and
• Subjects having plans to move in the next 1 year
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Other 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The primary outcome will be the net differences between the changes in the proportion of high-risk individuals treated with low-dose diuretics pre-and-post intervention between intervention and control villages.   12 months 
 
Secondary Outcome  
Outcome  TimePoints 
• The net difference in mean post-intervention blood pressure changes of high-risk patients from baseline between intervention and control villages;
• The proportion of high-risk individuals aware of the harms of smoking or high-salt diet;
• The proportion of high-risk individuals treated with aspirin;
• The proportion of high-risk individuals receiving 5 or more follow-up visits in a year;
• Hypertension awareness, treatment, and control rates.
 		 12 months 
 
Target Sample Size   Total Sample Size="2400"
Sample Size from India="1200" 
Final Enrollment numbers achieved (Total)= "2086"
Final Enrollment numbers achieved (India)="1050" 
Phase of Trial   N/A 
Date of First Enrollment (India)   09/07/2012 
Date of Study Completion (India) 31/03/2014 
Date of First Enrollment (Global)  01/12/2011 
Date of Study Completion (Global) 31/03/2014 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Completed 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 Tian M, Ajay VS, Dunzhu D, Hameed S, Li X, Liu Z, Li C, Chen H, Cho K, Li R, Zhao X, Jindal D, Rawal I, Ali MK, Peterson ED, Ji J, Amarchand R, Krishnan A, Tandon N, Xu LQ, Wu Y, Prabhakaran D, Yan L. A Cluster-Randomized Controlled Trial of a Simplified Multifaceted Management Program for Individuals at High Cardiovascular Risk (SimCard Trial) in Rural Tibet, China, and Haryana, India. Circulation. 2015 Jul 17. pii: CIRCULATIONAHA.115.015373. Ajay VS, Tian M, Chen H, Wu Y, Li X, Dunzhu D, Ali MK, Tandon N, Krishnan A, Prabhakaran D, Yan LL. A cluster-randomized controlled trial to evaluate the effects of a simplified cardiovascular management program in Tibet, China and Haryana, India: study design and rationale. BMC Public Health. 2014;14(1):924. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary  

The overall goal of the present proposal is to develop, pilot test, and evaluate a highly simplified but guideline-based program for cardiovascular management in resource-scarce settings.The specific aim is to evaluate the effects of implementing a simple low-cost cardiovascular management program for high-risk individuals, delivered by primary care providers and community healthcare workers (CHWs), on the proportion of patients appropriately treated with diuretics as well as a number of secondary outcomes.  The main features of the simplified cardiovascular management program include: 1) focus on high-risk for maximal cost-effectiveness; 2) simplified yet evidence-based measures; 3) systematic training of CHWs; 4) healthcare system strengthening with electronic decision support and performance feedback and payment; 5) adaptive interventional design; and 6) local government support.

Building on our prior experiences, the George Institute for Global Health, China in collaborations with the Public Health Foundation of India with cross-fertilization of ideas and expertise proposes to conduct a cluster-randomized controlled interventional pilot trialin the rural areas in Tibet, China and Haryana, India.  In each country, 12 villages will be selected to be randomized to receive the intervention (6 villages) or usual care (6 villages). Before the intervention begins, a village-wide screening will be done to identify and measure high-risk individuals in all villages. The intervention will be one year long.  A post-intervention assessment of all high-risk individuals will also be conducted. Process evaluation, economic evaluation, and verbal autopsy represent important aspects of the evaluation matrix. The results of the study are expected to both advance scientific knowledge to prepare for future large-scale studies and to provide translational evidence necessary for sound policy making to address the CVD problem in resource-scarce settings.        

 
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