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CTRI Number  CTRI/2024/07/070554 [Registered on: 13/07/2024] Trial Registered Prospectively
Last Modified On: 03/11/2024
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Other (Specify) [counseling]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   A clinical trial to study the effects of multi-intervention programme on perceived stress, quality of life and caregiver competency in patients with stroke  
Scientific Title of Study   Effect of multi-intervention programme on perceived stress and quality of life among stroke victims and care training programme on sense of competency among their caregivers.  
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
REF/2024/06/086132   ClinicalTrials.gov 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ligi K O  
Designation  Associate professor 
Affiliation  St.James college of nursing,Chalakudy. 
Address  Community health nursing department,St James college of nursing, Chalakudy, Thrissur,Kerala,India,680307

Thrissur
KERALA
680307
India 
Phone  9400666763  
Fax    
Email  srjyothikuriath@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr .Molly John 
Designation  HOD , Professor 
Affiliation  Amala college of nursing, Thrissur 
Address  Community Health Nursing Department,Amala college of nursing,Thrissur,Kerala,India,680555

Thrissur
KERALA
680555
India 
Phone  09496382109  
Fax    
Email  srmerlyjohn@gmail.com  
 
Details of Contact Person
Public Query  
Name  Ms.Sindhu 
Designation  Councillor,Ward 16 
Affiliation  St.James college of Nursing,Chalakudy. 
Address  16th Ward Councillor,Municipal office Chalakudy,Thrissur,Kerala,India,680307

Thrissur
KERALA
680307
India 
Phone  9539778299  
Fax    
Email  sindhuloju035@gmail.com  
 
Source of Monetary or Material Support  
Amala college of nursing,Thrissur,Kerala,India,680555 
 
Primary Sponsor  
Name  nil 
Address  nil 
Type of Sponsor  Other [no sponser] 
 
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 
Mrs Sindhu  Chalakudy municipality   First floor,Room no.2 Municipal office Chalakudy, Thrissur, Kerala, India 680307
Thrissur
KERALA 		 09539778299

sindhuloju035@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Amala Institute of Medical Sciences,ThrIissur  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 
Comparator Agent  control group  Counseling-once in a month Bensons relaxation therapy twice a day for 30 minutes and care training programme once in 3 months is not given for the control group  
Intervention  Counseling, Bensons relaxation therapy ,care training Programme  Counseling once in a month,Bensons relaxation Therapy twice a day for 30 mts,care training programme once in 3 months 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  Patients between 18-80 years with stroke
The patients who are in the 2- 4 disability level using modified rankin scale
Care givers below 75 years  
 
ExclusionCriteria 
Details  Stroke patients who recovered and can live independently.
Patients missing any of the sessions
Patients who cannot follow instructions
Patients who are not willing to participate
Care givers who have no communication skills  
 
Method of Generating Random Sequence   Coin toss, Lottery, toss of dice, shuffling cards etc 
Method of Concealment   An Open list of random numbers 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Decrease in perceived stress of stroke victims   Baseline ,4 weeks,8 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Increase in quality of life of stroke victims
Increase in competency of caregivers  		 0,1,2 months  
 
Target Sample Size   Total Sample Size="90"
Sample Size from India="90" 
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)   22/07/2024 
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="3"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary        It is projected that in every 40 seconds, there is someone who experiences a stroke . Stroke is the second most common cause of death accounting for approximately 12% of all deaths and third most common cause of disability globally. Stroke is a common, serious, and disabling global health-care problem. According to the WHO Collaborative Study in twelve countries, the stroke incidence rates were between 0.2- 2.5/1000 population per year. The purpose of the study is to decrease the perceived stress, increase the quality of life, and caregiver competency of stroke victims. The study participants will be recruited from July 10th  2024 onwards. 
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