| CTRI Number |
CTRI/2025/02/080969 [Registered on: 20/02/2025] Trial Registered Prospectively |
| Last Modified On: |
19/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Quality of Life and Factors Affecting Community Participation Among Elderly |
|
Scientific Title of Study
|
Quality of Life and Factors Affecting Community Participation Among Elderly in Trivandrum: A Mixed-Method Study |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Anjali Krishnan |
| Designation |
Post Graduate Student |
| Affiliation |
K.S. Hegde Medical Academy Nitte(Deemed to be University) |
| Address |
Department of Public Health
K.S. Hegde Medical Academy Nitte(Deemed to be University)
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
7026230636 |
| Fax |
|
| Email |
dr.anjalikrishnan.ph@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr Prajwal Jupiter Lobo |
| Designation |
Assistant Professor |
| Affiliation |
K S Hegde Medical Academy Nitte(Deemed to be University) |
| Address |
Department of Public Health
K S Hegde Medical Academy Nitte(Deemed to be University)
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8828224857 |
| Fax |
|
| Email |
prajwal.lobo@nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Mr Prajwal Jupiter Lobo |
| Designation |
Assistant Professor |
| Affiliation |
K S Hegde Medical Academy Nitte(Deemed to be University) |
| Address |
Department of Public Health
K S Hegde Medical Academy Nitte(Deemed to be University)
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
8828224857 |
| Fax |
|
| Email |
prajwal.lobo@nitte.edu.in |
|
|
Source of Monetary or Material Support
|
| K S Hegde Medical Academy, Mangalore, Dakshina Kannada, India
575018 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 |
| Dr Anjali Krishnan |
Department of Public Health, K S Hegde Medical Academy, Nitte(Deemed to be University) |
Derlakatte
Mangalore
Dakshina Kannada
KARNATAKA |
7026230636
dr.anjalikrishnan.ph@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| K S Hegde Medical Academy |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
NIL |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Individuals aged 60 years and above who are residents of selected Panchayats. |
|
| ExclusionCriteria |
| Details |
Individuals who are unable to speak, hear and comprehend at the time of data collection. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Quality of life among elderly population |
8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Barriers & facilitators of participation in community engaging activities among elderly population |
Eight weeks |
|
|
Target Sample Size
|
Total Sample Size="640"
Sample Size from India="640"
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)
|
03/03/2025 |
| 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="0"
Months="2"
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 - NO
|
|
Brief Summary
|
This is mixed-method study. Community-based descriptive cross-sectional study, to estimate the quality of life among elderly population and in-depth interview to gather qualitative insights into the experiences and perspectives of the elderly regarding their community participation. The study will be conducted in selected panchayat of Nedumangad Taluk in Trivandrum. The WHOQOL-BREF questionnaire consists of 26 items that assess quality of life across four domains: Physical health, psychological health, social relationships and environment. Each item is scored on a 5-point Likert scale, with higher scores indicating better quality of life. In-depth interview for assessing the barriers and facilitators of participation in community engaging activities among elderly population. Quantitative Data will be collected using Epicollect5. Data analysis will be done using Jamovi version 2.3.28 (or an updated version). |