| CTRI Number |
CTRI/2025/07/090899 [Registered on: 15/07/2025] Trial Registered Prospectively |
| Last Modified On: |
15/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A cross-sectional study on the influence of Social isolation, life satisfaction, and religiosity in diabetic older adults |
|
Scientific Title of Study
|
Exploring the interplay of Social isolation, life satisfaction, and religiosity in older adults with diabetes: A Community-based Cross-sectional 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 Shivani Rao |
| Designation |
Associate Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room no 343,
Department of Community Medicine, Maulana Azad Medical College and Associated Hospitals
Central
DELHI
110002
India |
| Phone |
9650729724 |
| Fax |
|
| Email |
shivani.idsp@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shivani Rao |
| Designation |
Associate Professor |
| Affiliation |
Maulana Azad Medical College |
| Address |
Room no 343,
Department of Community Medicine, Maulana Azad Medical College and Associated Hospitals
Central
DELHI
110002
India |
| Phone |
9650729724 |
| Fax |
|
| Email |
shivani.idsp@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Praveenkumar K R |
| Designation |
Junior Resident |
| Affiliation |
Maulana Azad Medical College |
| Address |
A 13/14, Feroz Shah Kotla, Vikram Nagar, Delhi-110002
Central
DELHI
110002
India |
| Phone |
8072377805 |
| Fax |
|
| Email |
praveensda95@gmail.com |
|
|
Source of Monetary or Material Support
|
| Maulana Azad Medical College, Delhi |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
N/A |
| Type of Sponsor |
Other [] |
|
|
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 Praveenkumar K R |
Urban Health Centre, Gokalpuri |
Urban Health Centre(field practice area), Maulana Azad Medical College, Gokalpuri-110094
North East
DELHI |
8072377805
praveensda95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Maulana Azad Medical College and Associated Hospitals Institutional Ethics Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E00-E89||Endocrine, nutritional and metabolic diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
45.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Adults aged more than or equal to 45 years of age with Diabetes Mellitus diagnosed for at least 12 months who have been residing in the study area for at least 1 year before the study |
|
| ExclusionCriteria |
| Details |
Any person not in a position to communicate due to ill health |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1) The proportion of patients with Diabetes Mellitus detected having social isolation |
1) The proportion of patients with Diabetes Mellitus detected having social isolation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Association of social isolation with Diabetes distress, life satisfaction & religiosity |
Association of social isolation with Diabetes distress, life satisfaction & religiosity |
|
|
Target Sample Size
|
Total Sample Size="262"
Sample Size from India="262"
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)
|
28/07/2025 |
| 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="0"
Months="6"
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
|
The study aims to find adult diabetes mellitus patients who suffer from social isolation and the inclination towards religiosity |