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CTRI Number  CTRI/2025/12/098444 [Registered on: 04/12/2025] Trial Registered Prospectively
Last Modified On: 05/12/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Single Arm Study 
Public Title of Study   Study to find out if teaching self-care practices can help people with blood pressure take their medicines as prescribed. 
Scientific Title of Study   Effectiveness of self care intervention on medication adherence among hypertensive adults residing in Palam area of Delhi. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  MITUL KHADIA 
Designation  PG STUDENT 
Affiliation  Lady Hardinge Medical College 
Address  DEPARTMENT OF COMMUNITY MEDICINE, LADY HARDINGE MEDICAL COLLEGE

Central
DELHI
110001
India 
Phone  9560981855  
Fax    
Email  mitulkhadia@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  MAMTA 
Designation  PROFESSOR 
Affiliation  Lady Hardinge Medical College 
Address  DEPARTMENT OF COMMUNITY MEDICINE, LADY HARDINGE MEDICAL COLLEGE

Central
DELHI
11001
India 
Phone  8826330735  
Fax    
Email  drmamtaapril@gmail.com  
 
Details of Contact Person
Public Query  
Name  MAMTA 
Designation  PROFESSOR 
Affiliation  Lady Hardinge Medical College 
Address  DEPARTMENT OF COMMUNITY MEDICINE, LADY HARDINGE MEDICAL COLLEGE

Central
DELHI
11001
India 
Phone  8826330735  
Fax    
Email  drmamtaapril@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  LADY HARDINGE MEDICAL COLLEGE 
Address  LADY HARDINGE MEDICAL COLLEGE, SHAHEED BHAGAT SINGH MARG, DELHI 
Type of Sponsor  Government medical college 
 
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 
MITUL KHADIA  Palam, New Delhi  PALAM VILLAGE, ADARSH GALI, PURAN NAGAR, HARIJAN BASTI
South West
DELHI 		 9560981855

mitulkhadia@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE, LADY HARDINGE MEDICAL COLLEGE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I10||Essential (primary) hypertension,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NOT APPLICABLE  NOT APPLICABLE 
Intervention  Self - care package  A self-care intervention package will be developed over one month. The intervention will be implemented over a period of two months. Each participant will receive a total of 60 minutes of intervention, delivered individually at the health centre. The content of the intervention will include: a 15-minute interactive health talk on hypertension, covering disease understanding and treatment with targeted messages and recommended goals; a 30-minute motivational interviewing session tailored to each participant, including individualized self-care plans with components such as how to take medications at home, setting reminders, demonstrating correct dosage, dosing frequency and proper labeling and packaging of tablets and a 15-minute demonstration on the steps of blood pressure monitoring based on standard guidelines. Reinforcement of intervention will be done by distribution of self-help pamphlet after 1 month followed by end line assessment after 3 months of the intervention.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  69.00 Year(s)
Gender  Both 
Details  Diagnosed adults with hypertension who had prescription for more than or equal to one anti hypertensive medication and are residing in Palam area of Delhi for the last 6 months. 
 
ExclusionCriteria 
Details  Participants who are unable to communicate due to any reason. Patients with secondary hypertension. Hypertensive patients with chronic complications which hinder daily self care. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Difference in proportion of study participants with medication adherence before and after the self-care intervention  AT START AND THEN AT END OF 3 MONTHS 
 
Secondary Outcome  
Outcome  TimePoints 
Proportion of factors associated with medication adherence.
 		  
Emerging codes and themes for medication non-adherence.

 		  
 
Target Sample Size   Total Sample Size="81"
Sample Size from India="81" 
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)   15/12/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  01/11/2025 
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   N/A 
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

  3. Who will be able to view these files?
    Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.

  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 - Proposals should be directed to [mitulkhadia@gmail.com].

  6. For how long will this data be available start date provided 09-12-2026 and end date provided 09-11-2032?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

The self-care package is a structured intervention designed to empower hypertensive patients to actively participate in the management of their illness. It is based on the WHO Package of Essential Noncommunicable (PEN) Disease framework and tailored to the local context. Although several national and international studies have evaluated educational or counseling-based interventions to improve medication adherence among hypertensive patients, there is still a paucity of research that integrates structured self-care interventions combining health education, motivational interviewing, and self-monitoring skills tailored to local sociocultural contexts. Most available studies in India have been conducted in tertiary care or hospital-based settings, with limited community-based evidence. Furthermore, there is a dearth of studies from Delhi, particularly in urban field practice areas like Palam, assessing the effectiveness of such comprehensive self-care interventions on medication adherence. This highlights the need for the present study.

 
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