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CTRI Number  CTRI/2021/09/036443 [Registered on: 13/09/2021] Trial Registered Prospectively
Last Modified On: 09/09/2021
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Qualitative study 
Study Design  Other 
Public Title of Study   To understand attitudes of family members regarding older adults participation in household chores in an urban area 
Scientific Title of Study   Understanding the attitudes of family members regarding older adults participation in home management and meal preparation in an Indian metropolis- A qualitative study  
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Nil  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Tanvi Sandeep Kambli  
Designation  MOT Neuro Rehabilitation  
Affiliation  Manipal Academy of Higher Education  
Address  3rd floor, Department of Occupational Therapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9619382102  
Fax    
Email  tanvi.kambli@learner.manipal.edu  
 
Details of Contact Person
Scientific Query  
Name  Dr Sebestina Anita Dsouza  
Designation  Professor 
Affiliation  Manipal Academy of Higher Education  
Address  3rd floor, Department of Occupational Therapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9448152143  
Fax    
Email  sebestina.dsouza@manipal.edu  
 
Details of Contact Person
Public Query  
Name  Dr Sebestina Anita Dsouza  
Designation  Professor 
Affiliation  Manipal Academy of Higher Education  
Address  3rd floor, Department of Occupational Therapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal

Udupi
KARNATAKA
576104
India 
Phone  9448152143  
Fax    
Email  sebestina.dsouza@manipal.edu  
 
Source of Monetary or Material Support  
Self funded  
 
Primary Sponsor  
Name  Tanvi Sandeep Kambli  
Address  3rd floor, Department of Occupational Therapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal  
Type of Sponsor  Other [Self funded ] 
 
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 
Tanvi Sandeep Kambli  Manipal Academy of Higher Education  3rd floor, Department of Occupational Therapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal.
Udupi
KARNATAKA 		 9619382102

tanvi.kambli@learner.manipal.edu 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  Healthy Individuals 
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Family members (aged 18-60 years) having at least one older adult (aged 60 years or above, who is ambulatory independently or with modified independence) residing with them.
2. Participants residing in Mumbai and those who can speak and understand English, Hindi and Marathi language.
 
 
ExclusionCriteria 
Details  1. Family members diagnosed with mental heath conditions like schizophrenia, bipolar disorders, major depressive disorders, and intellectual disabilities.
2. Family members having older adults that are diagnosed with mental health conditions like schizophrenia, bipolar disorders, major depressive disorders, and intellectual disabilities.  
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Themes that would be generated based on the Focus Group Discussions  Approximately after 6 months 
 
Secondary Outcome  
Outcome  TimePoints 
NA  NA 
 
Target Sample Size   Total Sample Size="48"
Sample Size from India="48" 
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)   15/09/2021 
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="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

Considering the rising population of the elderly in India, understanding the factors that could influence older adults’ participation in Instrumental Activities of Daily Living (IADLs), especially home management and meal preparation activities, is important to facilitate their performance. Majority of Indian elders today, as in the past, continue to live in a multigenerational family setting, and hence it is crucial to understand if and how the family members could influence their participation. Occupational therapy intervention commonly addresses IADLs, an essential indicator of healthy aging. However, as there is limited information available regarding older adults’ participation in IADLs, this study could help us to plan culturally tailored intervention programs for older adults taking into consideration their family members too.

It is a qualitative study; hence the recorded focus group discussion will be transcribed and transliterated into English. Each transcript will be considered as a unit of analysis and the transcripts will then be read several times to identify codes. Using thematic analysis, themes and sub-themes will be formulated.

The study participants will be recruited using the purposive sampling method based on the eligibility criteria from an Indian metropolis, Mumbai. An informed consent will be obtained from all the interested participants via telephonic interview and will also be sent via email along with the Participant Information Sheet. Once consent is obtained, online FGDs will be scheduled with the participants. After recruiting participants, they will be allocated to the appropriate focus groups to which they belong based on their relationship with the older adult, i.e., son, daughter, son-in-law, daughter-in-law, spouse, grandson, granddaughter. Each focus group discussion will have 4-6 participants and will be conducted on Google meet or Zoom which will be audio recorded. Field notes will also be taken during the interview.

 


 
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