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CTRI Number  CTRI/2024/08/072871 [Registered on: 22/08/2024] Trial Registered Prospectively
Last Modified On: 21/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [Empowerment Program]  
Study Design  Non-randomized, Active Controlled Trial 
Public Title of Study   Is there any Effect of empowerment program on loneliness, self esteem and wellbeing among older adults living in Old Age homes? 
Scientific Title of Study   Effect of an empowerment program on loneliness, self-esteem, and subjective well-being among older adult residing in selected residential homes of West Bengal 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  PURNIMA KUNDU 
Designation  Principal 
Affiliation  College of Nursing Medical College and Hospital kolkata pital, Kolkata 
Address  Department of Nursing Office of the Principal, 1st Floor College of Nursing Medical College and Hospital 88 College Street Kolkata West Bengal

Kolkata
WEST BENGAL
700073
India 
Phone  09432960542  
Fax    
Email  purnima_kundu@hotmail.com  
 
Details of Contact Person
Scientific Query  
Name  PURNIMA KUNDU 
Designation  Principal 
Affiliation  College of Nursing Medical College and Hospital kolkata pital, Kolkata 
Address  Department of Nursing Office of the Principal 1st Fllor College of Nursing Medical College and Hospital 88 College Street Kolkata West Bengal


WEST BENGAL
700073
India 
Phone  09432960542  
Fax    
Email  purnima_kundu@hotmail.com  
 
Details of Contact Person
Public Query  
Name  PURNIMA KUNDU 
Designation  Principal 
Affiliation  College of Nursing Medical College and Hospital kolkata pital, Kolkata 
Address  Department of Nursing Office of the Principal 1st Floor, College of Nursing Medical College and Hospital 88 College Street Kolkata West Bengal


WEST BENGAL
700073
India 
Phone  09432960542  
Fax    
Email  purnima_kundu@hotmail.com  
 
Source of Monetary or Material Support  
Medical College and Hospital Kolkata West Bengal  
 
Primary Sponsor  
Name  Funding by Prof Purnima Kundu  
Address  127 Pipulpati Mitrabagan Po Hooghly Dist Hooghly WestBengal 
Type of Sponsor  Other [Primary researchers own salary] 
 
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 
Prof Dr Arunansu Talukdar  Medical College and Hospital  Office of the HOD Department of Geriatric Medicine 4th Floor Super Speciality Building (SSB) 88 College Street Kolkata
Kolkata
WEST BENGAL 		 9831222514

dratalukdar@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Medical College and Hospital Kolkata  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  The healthy older adults volunteers aged between 60 to 75 and residing in selected old age homes of West Bengal 
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Empowerment Program  It is defined as an interactive group process that helps to identify the ways of increasing personal control and confidence which has an impact on loneliness, self-esteem, and well-being by actively participating in various types of group activities in the residential care home. The empowerment program is grouped under four dimensions; those are Physical empowerment, Psychological empowerment, Social empowerment, and self-monitoring of activities. The activities included are light exercise (balance, strength, and flexibility), story reading, story-telling, self-reflection in the form of sharing past life events, watching film shows, drawing/coloring/clay modeling/scrapbook making/caring of plants/ embroidering, self-monitoring of daily activities. The total duration of intervention for each group is 50 hours distributed within three months period.  
Comparator Agent  The usual program available   The usual program run in the old age homes such as exercise, social interaction, recreational activities. The total duration of comparator is 50 hours distributed within 3 months period. 
 
Inclusion Criteria  
Age From  60.00 Year(s)
Age To  75.00 Year(s)
Gender  Both 
Details  The older adults who will be
available during the data collection period
studied class VIII and above
are willing to participate
able to speak read write and understand Bengali  
 
ExclusionCriteria 
Details  The older adults who have physical immobility impaired hearing impaired vision diagnosed mental illnesses and impaired cognition as measured by MOCA Score less than 26 out of 30 and are too ill to attend the intervention 
 
Method of Generating Random Sequence    
Method of Concealment    
Blinding/Masking    
Primary Outcome  
Outcome  TimePoints 
Reduced level of loneliness among older adults
Increased level of self-esteem among older adults.
Increased level of subjective well-being among older adults
 		 Baseline assessment at the beginning of trial (Pre test assessment)
At beginning of 3rd month (1st Post test assessment) and at the end of 4th month ( 2nd Post test assessment) 
 
Secondary Outcome  
Outcome  TimePoints 
significant relationship between older adults loneliness level, self-esteem and subjective well-being  4 months 
 
Target Sample Size   Total Sample Size="176"
Sample Size from India="176" 
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)   01/11/2024 
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="3"
Months="6"
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 - 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 -  Study Protocol
    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 (Others) -  Guide Dr.Linu Sara George Co guide Dr Arunansu Talukdar

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Data are available indefinitely at (Link to be included in).

  6. For how long will this data be available start date provided 01-02-2026 and end date provided 31-12-2027?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This study is an interventional trial, the design being Non-Randomized Active Controlled trial. It is a single centered study in India. The main objective of the trial is to evaluate the effect of an empowerment program on loneliness, self-esteem and subjective well being of the older adults living in old age home. The total 50 hours of empowerment program includes the domains of physical, psychological, social empowerment and self monitoring of activities administered for 3 months and final post test evaluation will be commence on 4th month. The hypothesis of the study is: there is  significant difference in loneliness, self-esteem and subjective well-being of the older adults after participating in the empowerment intervention. The expected outcomes of the study are reduced level of loneliness, increased in self-esteem and subjective well-being of the older adults. 
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