| CTRI Number |
CTRI/2024/05/067694 [Registered on: 21/05/2024] Trial Registered Prospectively |
| Last Modified On: |
17/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
To investigate the stigma faced by caregivers of patients with severe mental illness getting treatment at tertiary care hospital by using sets of questionnaire & to understand how this stigma influences their quality of life and coping strategies |
|
Scientific Title of Study
|
A study to assess the association of perceived stigma with quality of life and coping strategies, among caregivers of patients with severe mental illness getting treatment at tertiary care hospital |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sarala Gaur |
| Designation |
M.sc. 1st year student |
| Affiliation |
AIIMS,New Delhi |
| Address |
Pota cabin 2,2nd floor College of Nursing All India Institute of Medical Science Ansari Nagar South Delhi 110029
New Delhi
DELHI
110029
India |
| Phone |
8279525488 |
| Fax |
|
| Email |
saraifan2017@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Mr. Ajesh Kumar TK |
| Designation |
Associate Professor |
| Affiliation |
AIIMS, |
| Address |
Room No. 2 2nd floor College Of Nursing Near Pota Cabin 2
AIIMS New ,Delhi
New Delhi
DELHI
110029
India |
| Phone |
9729389569 |
| Fax |
|
| Email |
ajesh.ktk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mr. Ajesh Kumar TK |
| Designation |
Associate Professor |
| Affiliation |
AIIMS,New Delhi |
| Address |
Room No 1, 2nd floor near, College of Nursing, All India Institute of Medical Science Ansari Nagar South Delhi 110029
New Delhi
DELHI
110029
India |
| Phone |
9729389569 |
| Fax |
|
| Email |
ajesh.ktk@gmail.com |
|
|
Source of Monetary or Material Support
|
| College of Nursing, AIIMS New Delhi Ansari Nagar south Delhi India pin code 110029 |
|
|
Primary Sponsor
|
| Name |
College of Nursing ALL INDIA INSTITUTE OF MEDICAL SCIENCE |
| Address |
College of nursing, ALL INDIA INSTITUTE OF MEDICAL SCIENCE, ANSARI NAGAR, NEW DELHI-110029 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nishtha Chawla |
ALL INDIA INSTITUTE OF MEDICAL SCIENCE NEW DELHI |
C1 WARD(PSYCHIATRIC WARD) 1st FLOOR MAIN BUILDING,ALL INDIA INSTITUTE OF MEDICAL SCIENCE ANSARI NAGAR NEW DELHI PIN CODE 110029
South
DELHI |
9013331056
nishtha.chawla@gmail.com |
| Dr Nishtha Chawla |
NEW RAJKUMARI AMRITKAUR OPD AIIMS NEW DELHI |
NEW RAJ KUMARI AMRIT KAUR OPD BUILDING PSYCHIATRIC OPD 1ST FLOOR A WING ANSARI NAGAR NEW DELHI 110029
South
DELHI |
9013331056
nishtha.chawla@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute ethics committee for post graduate research AIIMS new Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
caregivers of mentally ill patients |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
A family member of patient with severe mental illness which includes bi-polar affective disorders, psychosis, mood disorders and severe depressive disorders mention as per diagnostic criteria.
Parent, spouse, children, siblings.
Had most frequent contact with the patient.• Willing to participate in the study.
Caregivers aged between 18 to 60 years.
|
|
| ExclusionCriteria |
| Details |
Inability to Provide Informed Consent.
Care giver who is not able to follow the instructions.
Care giver suffering from a significant psychiatric disorder (as per known history).
Any condition interfering comprehension and cooperativeness.
Care givers of patient having comorbid psychiatric illness like substance abuse disorders (except tobacco dependence).
Care giver of patient having major medical illness requiring additional care due to frequent hospitalization or immobility for medical reasons.
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To assess the association of perceived stigma on quality of life of caregivers of patients with severe mental disorders.
2. To assess the association of perceived stigma on coping mechanism of caregivers of patients with severe mental disorders
|
baseline
|
|
|
Secondary Outcome
|
|
|
Target Sample Size
|
Total Sample Size="300"
Sample Size from India="300"
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)
|
01/06/2024 |
| 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 researcher aims to explore how perceived stigma is linked to the quality of life. Also wants to address the knowledge gap and emphases the necessity for targeted interventions to better support these caregivers. This investigation seeks to understand how caregivers can effectively manage the challenges they encounter. Hence, the researcher aims to explore how perceived stigma is linked to the quality of life. Also wants to address the knowledge gap and emphases the necessity for targeted interventions to better support these caregivers. This investigation seeks to understand how caregivers can effectively manage the challenges they encounter. |