| CTRI Number |
CTRI/2025/07/089908 [Registered on: 01/07/2025] Trial Registered Prospectively |
| Last Modified On: |
26/06/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Ageism and the Everyday Lives of Older People in Udupi |
|
Scientific Title of Study
|
A cross-sectional study to determine ageism and participation among older adults in Udupi |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sushma R |
| Designation |
Post graduate student |
| Affiliation |
Manipal College of Health Professions |
| Address |
3rd floor, Department of Occupational Therapy, MCHP, MAHE, Manipal, Karnataka
Udupi KARNATAKA 576104 India |
| Phone |
8122339411 |
| Fax |
|
| Email |
sushma.mchpmpl2024@learner.manipal.edu |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sebestina Anita Dsouza |
| Designation |
Professor |
| Affiliation |
Manipal College of Health Professions |
| Address |
Room no. 305, 3rd floor, Department of Occupational Therapy, MCHP, MAHE, Manipal
Udupi KARNATAKA 576104 India |
| Phone |
8122339411 |
| Fax |
|
| Email |
sebestina.dsouza@manipal.edu |
|
Details of Contact Person Public Query
|
| Name |
Dr Sebestina Anita Dsouza |
| Designation |
Professor |
| Affiliation |
Manipal College of Health Professions |
| Address |
Room no. 305, 3rd floor, Department of Occupational Therapy, MCHP, MAHE, Manipal
Udupi KARNATAKA 576104 India |
| Phone |
8122339411 |
| Fax |
|
| Email |
sebestina.dsouza@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal College of Health Professions, MAHE, Madhav nagar, Manipal-576104, Karnataka, India |
|
|
Primary Sponsor
|
| Name |
Manipal College of Health Professions |
| Address |
Manipal College of Health Professions, MAHE, Madhav nagar, Manipal-576104, Karnataka, India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Sushma R |
Kasturba Hospital |
Department of Occupational therapy, baliga block, Kasturba Hospital , MAHE, Madhav nagar, Manipal-576104, Karnataka Udupi KARNATAKA |
08122339411
sushma.mchpmpl2024@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- 2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Community-dwelling adults aged 60 and above of all genders, perform activities of daily living independently, and have adequate functional vision and hearing (with or without aids) |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Community-dwelling adults aged 60 and above of all genders, who are literate in English or Kannada, perform activities of daily living independently, and have adequate functional vision and hearing (with or without aids) as self-reported, caregiver-reported, or researcher-observed. |
|
| ExclusionCriteria |
| Details |
Older adults who are diagnosed with medical and psychiatric conditions that affect their ability to comprehend and understand, as self-reported, reported by caregivers, or observed by researchers |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To evaluate ageism among older adults in Udupi.
2. To evaluate IADLs and Social participation of older adults in Udupi.
|
1 day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To determine the relationship between ageism, IADLs, & social participation among older adults in Udupi. |
1 day |
|
|
Target Sample Size
|
Total Sample Size="107" Sample Size from India="107"
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)
|
14/07/2025 |
| 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="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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 - NO
|
|
Brief Summary
|
After the approval from the Clinical Trial registry, India registration is obtained. individuals who are 60 years and older will be approached for data collection using the convenience sampling method. Participants will be recruited from health camps, public places, the Department of Occupational Therapy, and through the researcher’s personal contacts. Eligibility will be determined based on the inclusion criteria. An elaborated participant information sheet will be provided to each potential participant, and informed consent will be obtained before participation. Participants’ demographic details will be collected. For the data collection, participants will then be provided with the Ageism Survey, the Lawton-Brody Instrumental Activities of Daily Living Scale, and the Participation scale, which are self-administered, pen-and-paper-based scales to gather data, which will take around 10 -15 minutes to complete. |