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CTRI Number  CTRI/2024/11/076565 [Registered on: 11/11/2024] Trial Registered Prospectively
Last Modified On: 06/02/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Rehabilitation]  
Study Design  Other 
Public Title of Study   Community intervention program to improve well being of for stroke survivors and decrease care giver stress 
Scientific Title of Study   Development and evaluation of a solution focused community intervention program for stroke survivors and their care givers 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Mercy Russelin Prabha R 
Designation  Research Scholar 
Affiliation  Government Medical College 
Address  Professor, Department of Medical Surgical Nursing, NIMS College of Nursing, Neyyattinkara

Thiruvananthapuram
KERALA
695123
India 
Phone  9443152247  
Fax    
Email  mercyprabha2@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Mercy Russelin Prabha R 
Designation  Research Scholar 
Affiliation  Government Medical College 
Address  Government Medical College, Medical College post, Thiruvananthapuram

Thiruvananthapuram
KERALA
695123
India 
Phone  9443152247  
Fax    
Email  mercyprabha2@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr.Anil Kumar 
Designation  Research Guide 
Affiliation  Government Medical College 
Address  Professor/ HOD Department of Psychiatry Government Medical College, Medical College post, Thiruvananthapuram

Thiruvananthapuram
KERALA
695011
India 
Phone  9443152247  
Fax    
Email  aniltvindups@gmail.com  
 
Source of Monetary or Material Support  
Department of Physical Medicine and Rehabilitation, Government Medical College, Thiruvananthapuram 
 
Primary Sponsor  
Name  Mercy Russelin Prabha R 
Address  Professor, Department of Medical Surgical Nursing, NIMS College of Nursing, Neyyattinkara  
Type of Sponsor  Private hospital/clinic 
 
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 
DrAnil Kumar  Government Medical College,   Professor/HOD Department of Psychiatry,Government Medical College, Thiruvananthapuram.
Thiruvananthapuram
KERALA 		 9443152247
04712223632
aniltvindups@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Human Ethics Comittee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Care givers 
Patients  (1) ICD-10 Condition: G822||Paraplegia,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Evaluate the effect of solution focussed Community intervention programme  Study participants are the primary care givers and stroke survivors residing in Neyyattinkara taluk selected by purposive sampling technique. Based on these data, the investigator conducts home visit to perform the intervention. Pretest will be done to assess the functional capacity of stroke survivors and level of care giver burden. The investigator will implement solution focused community intervention activities. Post test will be conducted after 6 weeks. 
Comparator Agent  NOT APPLICABLE  NOT APPLICABLE 
 
Inclusion Criteria  
Age From  40.00 Year(s)
Age To  70.00 Year(s)
Gender  Both 
Details  1. Primary Care giver of patient with confirmed diagnosis of stroke
2. Stroke survivors currently undergoing treatment at home 
 
ExclusionCriteria 
Details  Unwillingness 
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1. Increase well being of stroke survivor
2. Decrease care giver stress 		 6 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Improvement in feeding, grooming and self care activities.  6 weeks 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   01/12/2024 
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="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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 (Others) -  Findings and abstract of the study

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report
    Response -  Analytic Code

  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 identiļ¬ed for this purpose.

  4. For what types of analyses will this data be available?
    Response - Any purpose.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [mercyprabha2@gmail.com].

  6. For how long will this data be available start date provided 10-10-2024 and end date provided 10-10-2030?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary
Modification(s)  		 First phase of the study was completed as qualitative approach. Objective of qualitative phase is to explore the factors influencing the functional capacity of stroke  survivors  as perceived by relevant stakeholders. Based on the findings of qualitative phase, recruitment of sample for intervention is started. 
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