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CTRI Number  CTRI/2025/05/087913 [Registered on: 30/05/2025] Trial Registered Prospectively
Last Modified On: 29/05/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Behavioral 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A web based care for patients with mechanical heart valve replacement for improving their quality of life and treatment adherence  
Scientific Title of Study   A randomized control trial to assess the effect of Digital Interective Programme (DIP) on quality of life and treatment adherence among patients with mechanical heart valve replacement in a tertiary care hospital. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  ABRITTI BHANDARI 
Designation  Student  
Affiliation  College of Nursing, AIIMS New Delhi 
Address  Porta Cabin 2, College of Nursing, AIIMS New Delhi

South
DELHI
110029
India 
Phone  8927997881  
Fax    
Email  abrittibhandrai@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR SHASHI MAWAR 
Designation  Associate Professor 
Affiliation  College of Nursing, AIIMS New Delhi 
Address  Room No 4, College of Nursing, AIIMS New Delhi

South
DELHI
110029
India 
Phone  8800228317  
Fax    
Email  drshashimawar@gmail.com  
 
Details of Contact Person
Public Query  
Name  ABRITTI BHANDARI 
Designation  Student 
Affiliation  College of Nursing, AIIMS New Delhi 
Address  Porta Cabin 2, College of Nursing, AIIMS New Delhi

South
DELHI
110029
India 
Phone  8927997881  
Fax    
Email  abrittibhandrai@gmail.com  
 
Source of Monetary or Material Support  
ABRITTI BHANDARI 
ROOM NO-4,1ST FLOOR,COLLEGE OF NURSING, AIIMS NEW DELHI,INDIA, PIN-110029 
 
Primary Sponsor  
Name  ABRITTI BHANDARI 
Address  Porta cabin 2, College of Nursing, AIIMS New Delhi, PIN- 110029 
Type of Sponsor  Other [None] 
 
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 Shashi Mawar  College of Nursing, AIIMS New Delhi  CT3 WARD, 3RD FLOOR, CARDIO NEURO CENTRE, AIIMS NEW DELHI,INDIA, PIN-110029
South
DELHI 		 8800228317

abrittibhandrai@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTE ETHICS COMMITTEE FOR POST GRADUATE RESEARCH, AIIMS  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I39||Endocarditis and heart valve disorders in diseases classified elsewhere,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Usual care  Discharged summary includes prescribed medications and follow up schedule 
Intervention  Web based care for mechanical heart valve replacement patients  Medication management diet exercise and sleep warning sign Report uploading Home care based videos chatbpx Total duration-3 months 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  No complications within 1 week of surgery
Patient or their family members using smartphone. 
 
ExclusionCriteria 
Details  Patient with cognitive and mental disorder
Severe heart failure 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Quality of life
 		 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
Treatment Adherence  1 month and 3 months 
 
Target Sample Size   Total Sample Size="150"
Sample Size from India="150" 
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)   01/08/2025 
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="0"
Months="5"
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 - All of the individual participant data collected during the trial, after de-identiļ¬cation.

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

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [abrittibhandrai@gmail.com].

  6. For how long will this data be available start date provided 30-11-2026 and end date provided 19-07-2031?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   A RCT is conducted with the aim to explore the effectiveness of a Digital Interective Programme on quality of life and treatment adherence among patients with Mechanical heart valve replacement. Research approach is Quantitative approach. Sample population for my study is patient underwent valve replacement, in patient and whose who are attending in cardiology OPD of AIIMS, New Delhi .Sampling technique is allocation as per computer generated random table.   Collection of baseline data is at the time of admission.A web site link will be shared with the patients who meet the inclusion criteria and explaining the features in the Intervention group and usual care will be provided within control group. Reinforcement of the intervention within Interventional group on 3 rd and 4 th post operative day. Then follow up in 1 month for assessing treatment adherence by using the data collection tools for both the group. and then again follow up in 3 months for assessing quality of life and treatment adherence. At the end data will be analysed through descriptive and inferential statistics. 
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