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CTRI Number  CTRI/2016/02/006678 [Registered on: 25/02/2016] Trial Registered Retrospectively
Last Modified On: 24/02/2016
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Other 
Public Title of Study   Improving the control of high blood pressure in rural India 
Scientific Title of Study   Improving the control of hypertension in rural India: Overcoming barriers to diagnosis and effective treatment (CHIRI) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr K R Thankappan 
Designation  Professor and Head 
Affiliation   
Address  Achutha Menon Centre for Health Science Studies Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum

Thiruvananthapuram
KERALA
695011
India 
Phone  04712524231  
Fax    
Email  kavumpurathu@yahoo.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr K R Thankappan 
Designation  Professor and Head 
Affiliation   
Address  Achutha Menon Centre for Health Science Studies Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum

Thiruvananthapuram
KERALA
695011
India 
Phone  04712524231  
Fax    
Email  kavumpurathu@yahoo.com  
 
Details of Contact Person
Public Query
 
Name  Dr K R Thankappan 
Designation  Professor and Head 
Affiliation   
Address  Achutha Menon Centre for Health Science Studies Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum

Thiruvananthapuram
KERALA
695011
India 
Phone  04712524231  
Fax    
Email  kavumpurathu@yahoo.com  
 
Source of Monetary or Material Support    
Primary Sponsor  
Name  Prof K R Thankappan 
Address  Achutha Menon Centre for Health Science Studies Sree Chitra Tirunal Institute for Medical Sciences and Technology Trivandrum, Kerala, India- 695 011 Tel: 91-471-2524400, Fax: 91-471-2446433/2553469 kavumpurathu@yahoo.com  
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 3  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Pallab Maulik  East Godavari, Andhra Pradesh  Dr Pallab K Maulik, the George Institute for Global Health 219-221, Splendor forum, Plot # 3, Jasola district centre, New Delhi - 110025
East Godavari
ANDHRA PRADESH 
01141588091
01141588090
pmaulik@georgeinstitute.org.in 
Dr Nihal Thomas  Rishi valley, Andhra Pradesh  Dr. Nihal Thomas, Professor and Head, department of Endocrinology, diabetes and metabolic syndrome and vice principal (research), Christian medical College, Vellore - 632004.
Chittoor
ANDHRA PRADESH 
04162282694

nihal_thomas@yahoo.com 
Prof K R Thankappan  Thiruvananthapuram, Kerala  Prof. K R Thankappan, Head Achutha Menon Centre for Health Science Studies, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum -695011
Thiruvananthapuram
KERALA 
914712524231
914712446433
kavumpurathu@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 3  
Name of Committee  Approval Status 
Centre for Chronic Disease Control  Approved 
Institute Ethics Committee, Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum   Approved 
Office of Research Institutional Review Board, Christian Medical College, Vellore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Hypertension,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Leaflets on hypertension control  Leaflets describing the behavioral intervention for hypertension control and the need for medication adherence will be distributed to all the control hypertensive patients. They will be also advised to go to their usual health care provider for treatment.  
Intervention  Lifestyle interventions through accredited social health activists (ASHAs.   This is lifestyle intervention delivered by ASHA workers for three months at individual and group level to reduce unhealthy diet, including salt consumption, alcohol consumption, encourage physical activity through peer support and improve hypertension medication adherence. Blood pressure, weight and waist circumference monitoring will be done once in two weeks. This is a life style intervention provided by ASHAs for three month. Each participant will be given life style intervention for one hour duration once in every two weeks. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Individuals aged 18 years and above, already aware of hypertension, understanding of the local language, willing to attend a local facility to participate in the program will be included in the study. 
 
ExclusionCriteria 
Details  Individuals aged less than 18 years. Non hypertensives  
 
Method of Generating Random Sequence   Other 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The primary outcome will be the proportion of hypertensives who achieved adequate control   After three months of intervention  
 
Secondary Outcome  
Outcome  TimePoints 
Proportion of hypertensives aware of
The condition and taking medication

Fidelity and process measures of the program will be obtained via meeting reports and attendance records of meetings

System outcomes of the program will be obtained via surveys of ASHA and health providers at the end of the intervention.
 
Three months 
 
Target Sample Size   Total Sample Size="1800"
Sample Size from India="1800" 
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)   19/11/2015 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   Not Published 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary   The main objective of the study is to pilot and evaluate a group based self management education and support intervention program to improve the control of hypertension in three epidemiologically and demographically different locations in rural India at three months compared with the control arm (people with hypertension who do not participate in the group based program).

The pilot study will be conducted in three sites, Trivandrum in Kerala and the East Godavari district and Rishy Valley region in Andhra Pradesh.  The pilot intervention will be implemented via community based groups to reduce unhealthy diet (including reducing salt and alcohol consumption), encourage physical activity, and improve adherence to anti-hypertensive medication.  Blood pressure and weight monitoring will be undertaken every two weeks.

This study is a collaborative effort between Monash University, Australia and three participating sites: Sree Chitra Tirunal Institute for Medical Sciences and Technology, Trivandrum, Kerala, George Institute for Global Health India, Hyderabad, Andhra Pradesh and Christian Medical College, Vellore, Tamil Nadu.
 
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