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CTRI Number  CTRI/2019/10/021827 [Registered on: 31/10/2019] Trial Registered Prospectively
Last Modified On: 01/08/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Single Arm Study 
Public Title of Study   A program to increase knowledge about high blood pressure with the help of community in a village of Chandigarh  
Scientific Title of Study   Health literacy for management and control of hypertension: a participatory action intervention in a village of Chandigarh 
Trial Acronym  HL_PAR 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Reetu 
Designation  PhD scholar 
Affiliation  PGIMER 
Address  Department of community medicine and school of public health, PGIMER, Chandigarh, India

Chandigarh
CHANDIGARH
160012
India 
Phone  9814488806  
Fax    
Email  reetu_passi@yahoo.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Manmeet Kaur 
Designation  Professor Health Promotion 
Affiliation  PGIMER 
Address  Department of community medicine and school of public health, PGIMER, Chandigarh, India
pgimer pgimer
Chandigarh
CHANDIGARH
160012
India 
Phone    
Fax    
Email  mini.manmeet@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Reetu 
Designation  PhD scholar 
Affiliation  PGIMER 
Address  Department of community medicine and school of public health, PGIMER, Chandigarh, India

Chandigarh
CHANDIGARH
160012
India 
Phone  9814488806  
Fax    
Email  reetu_passi@yahoo.com  
 
Source of Monetary or Material Support  
Indian council of medical research, Ansari nagar, New Delhi, India, 110029 
 
Primary Sponsor  
Name  Fellowship ICMR 
Address  Indian council of medical research, Ansari nagar, New Delhi, India, 110029 
Type of Sponsor  Research institution 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Reetu  Post graduate institute of medical education and research, Chandigarh, India  Village Faidan Nizampur, Chandigarh, India, 160047.
Chandigarh
CHANDIGARH 		 9814488806

reetu_passi@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Post Graduate Institute of Medical Education and Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Adults 
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NA  NA 
Intervention  Participatory action intervention  Community based intervention in a village for six months to improve health literacy of villagers for management and control of hypertension 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  99.00 Year(s)
Gender  Both 
Details  Residents of village
Residing in village for next two years
Consenting adults 
 
ExclusionCriteria 
Details  Pregnant females
Non consenting adults
Non residents of village
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Medication adherence for anti hypertension drugs  one year 
 
Secondary Outcome  
Outcome  TimePoints 
Routine follow ups
Blood pressure
Salt intake
Body Mass Index
Waist-Hip ratio
Other practices to manage and control hypertension like physical activity, alcohol consumption and smoking
 		 one year 
 
Target Sample Size   Total Sample Size="520"
Sample Size from India="520" 
Final Enrollment numbers achieved (Total)= "510"
Final Enrollment numbers achieved (India)="510" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/11/2019 
Date of Study Completion (India) 31/08/2021 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="2"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 Passi R, Kaur M, Lakshmi PV, Cheng C, Hawkins M, Osborne RH. Health literacy strengths and challenges among residents of a resource-poor village in rural India: Epidemiological and cluster analyses. PLOS Global Public Health. 2023 Feb 17;3(2):e0001595. 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response (Others) -  As a supplementary file with the publication

  6. For how long will this data be available start date provided 31-07-2022 and end date provided 31-07-2024?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Not yet
Brief Summary
Modification(s)  

Health Literacy (HL) can help improve screening, treatment compliance and outcomes of chronic conditions, like hypertension, which is on the rise in Indian populations. A people’s centered approach to increase health literacy levels is required. Thus, our research aims to develop and implement such intervention to use and improve HL of residents of a village and thereafter measuring its effectiveness in building their capacity for managing and controlling hypertension. A mixed method design will be followed, where the intervention follows proceeding/ repeated cycles of participatory action research (PAR) including planning, action, observation and reflection on the basis of needs and gaps identification of the selected community through qualitative and quantitative baseline data collection.

 
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