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CTRI Number  CTRI/2018/07/014742 [Registered on: 05/07/2018] Trial Registered Prospectively
Last Modified On: 04/07/2018
Post Graduate Thesis  No 
Type of Trial  Observational 
Type of Study   Cohort Study 
Study Design  Other 
Public Title of Study   LHS4CVD A " Learning Health Systems For Cardio-Vascular Diseases"  
Scientific Title of Study   A Learning Health System For adherence to secondary prevention in Cardio-Vascular Disease in Kerala informatics and non-physician health workers- a 1 year prospective study 
Trial Acronym  LHS4CVD 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Jaideep C Menon 
Designation  Cardiologist 
Affiliation  Amrita Institute of Medical Sciences 
Address  Department of Adult Cardiology Amrita Institute of Medical Sciences, Ponekkara, Kochi 682041
3/113 A,Janaki Mandiram, Kothakulangara,ANGAMALY
Ernakulam
KERALA
683572
India 
Phone  09447352684  
Fax  04842802120  
Email  menon7jc@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Jaideep C Menon 
Designation  Cardiologist 
Affiliation  Amrita Institute of Medical Sciences 
Address  Janaki Mandiram, Kothakulangara,ANGAMALY
Janaki Mandiram, Kothakulangara,ANGAMALY

KERALA
683572
India 
Phone  09447352684  
Fax  04842802120  
Email  menon7jc@gmail.com  
 
Details of Contact Person
Public Query  
Name  Jaideep C Menon 
Designation  Cardiologist 
Affiliation  Amrita Institute of Medical Sciences 
Address  Department of Adult Cardiology, Amrita Institute of Medical Sciences, Ponekkara Ernakulam 682041
3/113A, Janaki Mandiram, Kothakulangara,ANGAMALY
Ernakulam
KERALA
683572
India 
Phone  09447352684  
Fax  04842802120  
Email  menon7jc@gmail.com  
 
Source of Monetary or Material Support  
EUROPEAN UNION GRANT - REWARD Grant agreement 339239 
 
Primary Sponsor  
Name  EUROPEAN COMMISSION 
Address  European Commission,European Research Council Executive agency, C2, COV2 Rue de la Loi 200, B-1049 Brussels, Belgium  
Type of Sponsor  Other [International grant] 
 
Details of Secondary Sponsor  
Name  Address 
Research and Information Systems for developing countries Govt of India  Core IV B, Fourth floor, India Habitat Centre, Lodhi road, New Delhi 110003 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Jaideep C Menon  AIMS, KOCHI  DEPARTMENT OF ADULT CARDIOLOGY,AMRITA INSTITUTE OF MEDICAL SCIENCES,PONNEKKARA, KOCHI
Ernakulam
KERALA 		 9447352684
04842802120
menon7jc@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 2  
Name of Committee  Approval Status 
IEC, Amrita Institute of Medical Sciences  Approved 
IEC, Amrita Institute of Medical Sciences  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  on medical management,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  Aims to study the adherence and persistence with medicines in patients with Cardio-Vascular disease. Inclusion criterion include all patients with established CVD irrespective of age or sex. There is no intervention intended and the study is purely observational 
 
ExclusionCriteria 
Details  Individuals without CVD, or individuals who cannot give a consent. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
to study the adherence persistence patterns to medications in patients with CVD  follow up period of 1 year 
 
Secondary Outcome  
Outcome  TimePoints 
not applicable  not applicable 
 
Target Sample Size   Total Sample Size="2000"
Sample Size from India="2000" 
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)   05/07/2018 
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="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   ENDIRA cohort is in a population of 114,064 spread over 5 panchayats in Ernakulam district, Kerala. The investigators had previously looked at the prevalence of NCD’s including diabetes, HTN, Dyslipidemia, COPD, cancers, heart disease and stroke the details of which have been published. Behavioural  habits vis a vis use of tobacco and alcohol, anxiety levels diet patterns which included type and quantity of oil and use of red meats along with anthropometric measures - Height/weight and BMI were what was measured in this population.
 The present study envisages looking at adherence and persistence to medication patterns, in patients with established CVD. In the ENDIRA registry 1688 patients of CVD had been identified, 1201 of heart disease and 487 of CVA. We would be identifying these individuals to look at adherence. 
ASHA workers who have been trained for the same would be entering details of individual patients on a Tab PC with a software developed for the same. Individual consents would be taken on consent sheets on the PC itself. Adherence and persistence is assessed from the Morisky scale for adherence. 
 This would be the first large scale study in India assessing drug adherence in the general population.
 
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