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CTRI Number  CTRI/2025/06/088006 [Registered on: 02/06/2025] Trial Registered Prospectively
Last Modified On: 23/04/2026
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Knowledge and practices]  
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   App regarding home care management of stroke patients for caregivers of stroke patients to improve their knowledge and practices 
Scientific Title of Study   A Randomised control trial to assess the effectiveness of Stroke Care Giver Mobile App SCGM app upon knowledge and practices of home care management among caregivers of stroke patients at AIIMS New Delhi 
Trial Acronym  NILL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  VIJAYKUMAR C 
Designation  Student (Neurosciences Nursing)  
Affiliation  College of Nursing, AIIMS, New Delhi  
Address  Porta cabin 2, College of Nursing, AIIMS, Ansari Nagar, New Delhi

South
DELHI
110029
India 
Phone  8508828878  
Fax    
Email  ghostriderpuli@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  DR LATHA VENKATESAN 
Designation  Principal cum professor  
Affiliation  College of Nursing, AIIMS, New Delhi  
Address  Principal office, College of Nursing, AIIMS, Ansari Nagar, New Delhi

South
DELHI
110029
India 
Phone  9310502069  
Fax    
Email  latha6901@yahoo.com  
 
Details of Contact Person
Public Query  
Name  VIJAYKUMAR C 
Designation  Student (Neurosciences Nursing)  
Affiliation  College of Nursing, AIIMS, New Delhi  
Address  Porta cabin 2, College of Nursing, AIIMS, Ansari Nagar, New Delhi

South
DELHI
110029
India 
Phone  8508828878  
Fax    
Email  ghostriderpuli@gmail.com  
 
Source of Monetary or Material Support  
All India Institute of medical sciences, New Delhi 
VIJAYKUMAR C 
 
Primary Sponsor  
Name  VIJAYKUMAR C 
Address  244, 1st Floor, DDA Flats Lado sarai, New Delhi 110030 
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 Latha Venkatesan  College of Nursing, AIIMS, New Delhi   Portacabin 2, 2nd floor, College of Nursing, AIIMS, New Delhi
South
DELHI 		 9310502069

ghostriderpuli@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
e-IRB  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I639||Cerebral infarction, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  SCGM app  Information regarding home care management on Hand hygiene and use of gloves, Feeding: Ryles tube, Oral Feeding, Providing medication Prevention of aspiration. Elimination needs: Urinary catheter care, Skin care and prevention of pressure ulcers Active and passive exercises. Intervention will be until 2-3 weeks or during discharge, whichever is earlier  
Comparator Agent  Usual Care   Usual Care till discharge 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  Caregivers aged 18 years or older up-to 65years
Primary caregivers of stroke patients
(family members, close friends)
Caregivers of patients diagnosed with stroke and are in acute management
Caregivers who own a smartphone and have regular internet access
Caregivers who can read and understand the local language (e.g., Hindi, English).
Caregivers who provide informed consent and are willing to use the mobile app as part of the study.
 
 
ExclusionCriteria 
Details  Caregivers with prior experience using similar mobile apps specifically designed for stroke care.
Caregivers with cognitive impairments or severe visual/hearing impairments that would prevent them from effectively using the app
Caregivers who are not the primary caregiver for the stroke patient Caregivers currently participating in other clinical trials or studies related to stroke care.
Caregivers unwilling to commit to the duration and requirements of the study
Patients who are already having pressure ulcer
 
 
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 
Knowledge and practices  From admission to discharge, or 2-3 weeks whichever is earlier  
 
Secondary Outcome  
Outcome  TimePoints 
Practices   1-2 months 
 
Target Sample Size   Total Sample Size="100"
Sample Size from India="100" 
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
Modification(s)  		 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 [ghostriderpuli@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
Modification(s)  		 A RCT is conducted with the aim to explore the effectiveness of Stroke Care Giver Mobile App (SCGM app) upon knowledge and practices of homecare management among care givers of stroke patients. Research approach is quantitative approach. Sample population for my study is care givers of stroke patients who are admitted for treatment of stroke in AIIMS, New Delhi. Sampling technique is allocation as per computer generated random table. Collection of baseline data is at time of admission. Pretest knowledge and practice will be assessed through self-developed knowledge and practice score questionnaire. SCGM application will be shared with the patients who met the inclusion criteria and explaining the features in intervention group and usual care will be provided within control group. Post test of knowledge and practice will be assessed before discharge through self-developed knowledge and practice score questionnaire. At the end data will be analyzed through descriptive and inferential statistics.  
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