| CTRI Number |
CTRI/2023/03/050621 [Registered on: 13/03/2023] Trial Registered Prospectively |
| Last Modified On: |
17/10/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
A study of Depression, Burden of Care and Health behaviors in caregivers of patients admitted in Intensive care units. |
|
Scientific Title of Study
|
A study of psychological consequences in caregivers of patients admitted in intensive care units. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Dheeraj Mewara |
| Designation |
P.G Resident doctor M.D. Psychiatry |
| Affiliation |
Pacific medical college and hospital |
| Address |
Department Of Psychiatry, Unit: I, Room No.:07, PMCH, Bhilon ka Bedla, Udaipur, Rajasthan
Department Of Psychiatry, PMCH, Bhilon ka Bedla, Udaipur, Rajasthan
Udaipur
RAJASTHAN
313011
India |
| Phone |
8112298306 |
| Fax |
|
| Email |
drdheerajmewara@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr SG Mehta |
| Designation |
Professor & HOD, M.D. (Psychiatry) |
| Affiliation |
Pacific medical college and hospital |
| Address |
Department Of Psychiatry, Room No.:07, PMCH, Bhilon ka Bedla, Udaipur, Rajasthan
Department Of Psychiatry, PMCH, Bhilon ka Bedla, Udaipur, Rajasthan
Udaipur
RAJASTHAN
313011
India |
| Phone |
9116476422 |
| Fax |
|
| Email |
drsureshmehta@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Dheeraj Mewara |
| Designation |
P.G Resident doctor M.D. Psychiatry |
| Affiliation |
Pacific medical college and hospital |
| Address |
Department Of Psychiatry, Unit: I, Room No.:07, PMCH, Bhilon ka Bedla, Udaipur, Rajasthan
Department Of Psychiatry, PMCH, Bhilon ka Bedla, Udaipur, Rajasthan
Udaipur
RAJASTHAN
313011
India |
| Phone |
8112298306 |
| Fax |
|
| Email |
drdheerajmewara@gmail.com |
|
|
Source of Monetary or Material Support
|
| Pacific Medical College and Hospital, Bhilon Ka Bedla, Udaipur, Rajasthan |
|
|
Primary Sponsor
|
| Name |
Not applicable |
| Address |
Not applicable |
| 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 Dheeraj Mewara |
Pacific Medical College and Hospital, Bhilon Ka Bedla, Udaipur, Rajasthan |
Room No.: 07, Department of Psychiatry, Unit: I
Udaipur
RAJASTHAN |
8112298306
drdheerajmewara@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Pacific Medical College and Hospital, Udaipur, Rajasthan |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
ICU admitted patients family caregivers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
A) For patients: 1) Admitted in MICU or SICU for 7 or more days.
2) vitals stable at the time of interview.
For Caregivers: 1) Who will give consent to participate in the study.
2) Age group between 18 to 55 years, both genders. |
|
| ExclusionCriteria |
| Details |
A) For patients: Vitals unstable or prognosis guarded.
B) For Caregivers: 1) Those who have a history of major psychiatric disorder.
2) History of significant head injury or major medical illness. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Depression |
At Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Burden of care
Health behavior |
At Baseline |
|
|
Target Sample Size
|
Total Sample Size="240"
Sample Size from India="240"
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)
|
15/03/2023 |
| 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="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Open to Recruitment |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Not yet applicable |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This study is expected to elicit the various psychological sequelae of caregiving in family caregivers of ICU patients in form of depression, high perceived burden of care and negative health behaviors. Inclusion criteria for caregivers is who will give consent to participate in the study and age group between 18 to 55 years, both genders. Exclusion criteria for caregivers who have history of major psychiatric disorder and had history of significant head injury or major medical illness in which study instruments to be used is ZBI (Zarit burden interview) scale, CESD (Center of epidemiologic studies depression scale) scale, SAQ (Self-Assessment Questionnaire) scale. Based on the findings, we hope to increase awareness of these psychological phenomenon and screen for them. When dealing with such patients this will also help in providing early intervention, reducing morbidity and taking preventive measures for safeguarding mental health of caregivers of ICU patients, so that they can better support their family members. |