| CTRI Number |
CTRI/2021/09/036385 [Registered on: 09/09/2021] Trial Registered Prospectively |
| Last Modified On: |
11/12/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Qualitative |
| Study Design |
Other |
|
Public Title of Study
|
Understanding how older women residing in an urban area think regarding social participation |
|
Scientific Title of Study
|
Understanding perceptions of Indian urban older women regarding social participation: 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 |
Shah Hally Dharmendra |
| Designation |
Postgraduate Occupational Therapy Student |
| Affiliation |
Manipal College of Health Professions |
| Address |
3rd floor, Occupational Therapy Department, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9920559351 |
| Fax |
|
| Email |
shah.dharmendra@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Sebestina Anita Dsouza |
| Designation |
Professor |
| Affiliation |
Manipal College of Health Professions |
| Address |
3rd floor, Occupational Therapy Department, 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 |
Shah Hally Dharmendra |
| Designation |
Postgraduate Occupational Therapy Student |
| Affiliation |
Manipal College of Health Professions |
| Address |
3rd floor, Occupational Therapy Department, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9920559351 |
| Fax |
|
| Email |
shah.dharmendra@learner.manipal.edu |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Shah Hally Dharmendra |
| Address |
3rd floor, occupational therapy department, Manipal College of Health Professions, Manipal |
| Type of Sponsor |
Other [self-funded] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Shah Hally Dharmendra |
Manipal College of Health Professions |
3rd floor, Occupational therapy Department, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA |
9920559351
shah.dharmendra@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
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy individuals who can communicate and mobilize with or without aids |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Female |
| Details |
English or Hindi speaking older women above age 60 years and residing in Mumbai from at least one year would be recruited |
|
| ExclusionCriteria |
| Details |
Older women with any severe disabling condition or mental health problem that impedes
their ability to understand and communicate appropriately and those who are unable to walk or move around independently even with mobility aids.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Themes generated during FGD |
8 weeks
|
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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)
|
18/09/2021 |
| 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="10"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The share and size
of older people’s population have increased, and this rise has been more for older women as
compared to older men. With the rise in the ageing population, promoting health and wellbeing becomes a priority for healthy ageing. Social
participation is a significant causal factor of healthy ageing and people’s perception regarding the importance of being socially involved is
an essential determinant of social participation. Considering the rise in
population of older women, especially in urban areas, and considering their vulnerability and
dependency, supporting healthy ageing in urban older women in India and understanding their
perceptions regarding social participation is essential. 24 participants (older women above the age of 60 years) will be recruited for 4-6 Focused Group Discussions (FGDs). The FGDs would be conducted online. They would be audio recorded and data analysis would be done. |