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CTRI Number  CTRI/2024/10/075594 [Registered on: 22/10/2024] Trial Registered Prospectively
Last Modified On: 05/07/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Preventive 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   A Randomized Controlled Trial on Effectiveness of a Nurse-led Intervention for Prevention and Management of Depression among stroke survivors  
Scientific Title of Study   A Randomized Controlled Trial on Effectiveness of a Nurse led Intervention for Prevention and Management of Depression on incidence and level of depression among stroke survivors attending Neurological units PGIMER Chandigarh 2023-25 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Anupam Singh  
Designation  M.Sc.(N) student 
Affiliation  NINE, Postgraduate Institute of Medical Education and Research Chandigarh  
Address  Department of Mental Health Nursing,Room No.207, NINE, Postgraduate Institute of Medical Education and Research Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  8960968258  
Fax    
Email  sunflymax@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sunita Sharma  
Designation  Associate professor  
Affiliation  NINE, Postgraduate Institute of Medical Education and Research Chandigarh  
Address  Room no.206 NINE, Postgraduate Institute of Medical Education and Research Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  9876269615  
Fax    
Email  sanitasuni@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Anupam Singh  
Designation  M.Sc.(N) student 
Affiliation  NINE, Postgraduate Institute of Medical Education and Research Chandigarh  
Address  Department of Mental Health Nursing, Room no.207, NINE, Postgraduate Institute of Medical Education and Research Chandigarh

Chandigarh
CHANDIGARH
160012
India 
Phone  8960968258  
Fax    
Email  sunflymax@gmail.com  
 
Source of Monetary or Material Support  
Department of Neurology, Nehru Hospital, Postgraduate Institute of Medical Education and Research Chandigarh  
 
Primary Sponsor  
Name  Anupam Singh  
Address  Department of Mental Health Nursing, Room no.207, NINE, Postgraduate Institute of Medical Education and Research Chandigarh 160012 
Type of Sponsor  Other [self] 
 
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 Sunita Sharma  Postgraduate Institute of Medical Education and Research, Chandigarh   Hall-A and B, EMOPD, Department of Neurology, Postgraduate Institute of Medical Education and Research, Chandigarh
Chandigarh
CHANDIGARH 		 9876269615

sanitasuni@yahoo.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Postgraduate Institute of Medical Education and Research,Institutional Ethics Committee (Intramural)  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I60-I69||Cerebrovascular diseases,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Nurse led intervention like Reminiscence therapy, Behavioral activation therapy.  Reminiscence therapy include Joyful old memories and encourage physical activity and exercises. frequency one to two time and for the Duration of 2 months 
Comparator Agent  Routine care  Patients care as per doctors orders and routine care for the duration of 2 months  
 
Inclusion Criteria  
Age From  19.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  2 Week to 3 months of stroke survivors
Who can understand Hindi & English  
 
ExclusionCriteria 
Details  Unconscious patients
Patients diagnosed with depression 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
incidence of depression
level of depression 		 2 weeks to 8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
none  none 
 
Target Sample Size   Total Sample Size="86"
Sample Size from India="86" 
Final Enrollment numbers achieved (Total)= "86"
Final Enrollment numbers achieved (India)="86" 
Phase of Trial   N/A 
Date of First Enrollment (India)   29/10/2024 
Date of Study Completion (India) 30/11/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="2"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Completed 
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 -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  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 - Any purpose.

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

  6. For how long will this data be available start date provided 01-07-2024 and end date provided 31-08-2024?
    Response - Immediately following publication. No end date.

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

·      Globally, Stroke ranks as the second leading cause of death. Patients deal with severe post-stroke issues like depression. Effective care is therefore crucial to lowering post-stroke problems in patients. we seek to investigate the impact of NLI on depression symptoms among post-stroke patients because evidence from earlier research has shown that specialized nursing care improved post-stroke depression.

      Assessment and investigation of Depression among post stroke survivors by using Hamilton depression rating scale will be done, Counselling/ psycho Education will be provided by the Nurse to the Patient and care givers regarding post stroke depression prevention and management.

      So, this present study is planned to evaluate the effectiveness of ‘Nurse-led Intervention for Prevention and Management of Depression’ on knowledge and skills of nurses and its dissemination among patients with post-stroke Depression and their caregivers in selected wards of PGIMER, Chandigarh.

 
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