| CTRI Number |
CTRI/2025/09/094878 [Registered on: 16/09/2025] Trial Registered Prospectively |
| Last Modified On: |
15/09/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Behavioral |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Community based socialization intervention to address social isolation and loneliness among elderly |
|
Scientific Title of Study
|
Community-Based Group Intervention to Address Social Isolation and Loneliness Among the Elderly in a Rural Community in Tiruvallur District, Tamil Nadu |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vijayaprasad Gopichandran |
| Designation |
Head |
| Affiliation |
Omayal Achi College of Nursing |
| Address |
Omayal Achi Community Health Center
Department of Community Health Nursing
Room Number 2
1 69 Anna Salai Arakkampakkam Village Pandeswaram Post Ambattur Taluk Chennai
No 45 Ambattur Road Puzhal Chennai 600066
Chennai
TAMIL NADU
600055
India |
| Phone |
9445226806 |
| Fax |
|
| Email |
vijay.gopichandran@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Vijayaprasad Gopichandran |
| Designation |
Head |
| Affiliation |
Omayal Achi College of Nursing |
| Address |
Omayal Achi Community Health Center
Department of Community Health Nursing
Room Number 2
1 69 Anna Salai Arakkampakkam Village Pandeswaram Post Ambattur Taluk Chennai
No 45 Ambattur Road Puzhal Chennai 600066
TAMIL NADU
600055
India |
| Phone |
9445226806 |
| Fax |
|
| Email |
vijay.gopichandran@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Vijayaprasad Gopichandran |
| Designation |
Head |
| Affiliation |
Omayal Achi College of Nursing |
| Address |
Omayal Achi Community Health Center
Department of Community Health Nursing
Room Number 2
1 69 Anna Salai Arakkampakkam Village Pandeswaram Post Ambattur Taluk Chennai
No 45 Ambattur Road Puzhal Chennai 600066
TAMIL NADU
600055
India |
| Phone |
9445226806 |
| Fax |
|
| Email |
vijay.gopichandran@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Omayal Achi College of Nursing |
| Address |
No 45 Ambattur Road Puzhal Chennai 600066 |
| Type of Sponsor |
Other [Nursing College] |
|
|
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 Vijayaprasad Gopichandran |
Omayal Achi Community Health Centre |
Department of Community Health Nursing
Room Number 2
1 69 Anna Salai Arakkampakkam Village Pandeswaram Post Ambattur Taluk Chennai 600055
Chennai
TAMIL NADU |
9445226806
vijay.gopichandran@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ICCR Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Elderly with social isolation and loneliness |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Community-Based Elderly Social Support Intervention |
The community-based monthly group intervention will consist of:
• Social activities and group discussions on various health related topics
• Creative arts and recreational activities including music, drawing, dance and drama
• Health education and awareness sessions.
• Peer support for medical conditions like type 2 diabetes, hypertension, heart disease
• Cultural activities and celebrations.
The intervention will be designed to promote social interaction, enhance social skills, foster a sense of belonging, and improve mental well-being.
The intervention will last for one year.
|
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
60.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Men and women
Aged above 60 years
Living in the selected villages |
|
| ExclusionCriteria |
| Details |
Persons with disabilities limiting active participation in the group intervention
Persons with serious and terminal illnesses |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Effectiveness of the community-based group intervention on the mental health and well-being of the elderly participants Reach, utilization, acceptability, and sustainability of the community-based group intervention.
|
The effectiveness will be assessed at endline in comparison with baseline data.
reach, utilization, acceptability, sustainability will be assessed at endline. |
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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)
|
15/10/2025 |
| 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 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
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [vijay.gopichandran@gmail.com].
- For how long will this data be available start date provided 31-10-2026 and end date provided 31-10-2040?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
· Baseline assessment of social isolation and loneliness among the elderly in the community will be done. Baseline assessment of mental wellbeing using the PHQ9 tool for depression and anxiety will also be used. Implementation of a community based group intervention involving monthly get together in a central location will be organized. Various activities will be conducted to promote physical and mental health healthy food health awareness programs games and cultural activities for a period of 1 year. The community-based monthly group intervention will consist of: Social activities and group discussions on various health related topics Creative arts and recreational activities including music, drawing, dance and drama Health education and awareness sessions. Peer support for medical conditions like type 2 diabetes, hypertension, heart disease Cultural activities and celebrations. The intervention will be designed to promote social interaction, enhance social skills, foster a sense of belonging, and improve mental well-being. Endline assessment of social isolation and loneliness among the elderly in the community will be done. Also, mental health and wellbeing assessment will be done. Assessment of implementation outcomes such as reach, utilization, acceptability, and sustainability by conducting qualitative in-depth interviews among participants and local village leaders. |