| CTRI Number |
CTRI/2024/05/066968 [Registered on: 07/05/2024] Trial Registered Prospectively |
| Last Modified On: |
04/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Perceived stress, burden and quality of life in caregivers of schizophrenic and major depressive patients |
|
Scientific Title of Study
|
A comparative study of perceived stress, burden and quality of life in caregivers of patients with schizophrenia and depression |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Pulkit Mutreja |
| Designation |
Junior Resident |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Room Number T 13, Raghobaji Boys Hostel, Datta Meghe Institute of Higher Education and Research, Sawangi (M), Wardha, Maharashtra
Wardha
MAHARASHTRA
442001
India |
| Phone |
6295070390 |
| Fax |
|
| Email |
mutrejapulkit@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ragini Patil |
| Designation |
Professor and Head |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Datta Meghe Institute of Higher Education and Research, Sawangi (M), Wardha, Maharashtra
Wardha
MAHARASHTRA
442001
India |
| Phone |
6295070390 |
| Fax |
|
| Email |
ragini.tushar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Pulkit Mutreja |
| Designation |
Junior Resident |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Room Number T13, Raghobaji Hostel, Datta Meghe Institute of Higher Education and Research, Sawangi (M), Wardha, Maharashtra
Wardha
MAHARASHTRA
442001
India |
| Phone |
6295070390 |
| Fax |
|
| Email |
mutrejapulkit@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research |
| Address |
Datta Meghe Institute of Higher Education and Research, Sawangi (Meghe), Wardha, Maharashtra |
| Type of Sponsor |
Private medical 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 Pulkit Mutreja |
Datta Meghe Institute of Higher Education and Research |
Seminar Room, Department of Psychiatry, Acharya Vinoba Bhave Rural Hospital
Wardha
MAHARASHTRA |
6295070390
mutrejapulkit@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Higher Education and Research Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Stress, anxiety, care giver burden |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1)Age: 18-60 years
2)Staying the patient currently and for greater than or equal to 3 years prior to the assessment with the patient
3)Accompanying the patient more than 2 hours a day
4)Having meals together with the patient more than four times a week
5)Doing leisure activities, such as going to the movies or taking a walk together, more than once a week
6)Helping the patient with daily activities, such as with taking medicine, more than four times a week on average during the previous year.
|
|
| ExclusionCriteria |
| Details |
Caregivers suffering from disabling psychiatric or physical illnesses (including but not limited to schizophrenia, bipolar affective disorder, major depressive disorder, cerebrovascular accidents, myocardial infarction, neoplasms) |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Perceived stress, burden and quality of life expected worse in caregivers of schizophrenia compared to caregivers of depression |
6 months, 1 year, 18 months, 2 years |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Perceived stress, burden & quality of life expected worse in caregivers of depression compared to caregivers of schizophrenia |
6 months, 1 year, 18 months, 2 years |
|
|
Target Sample Size
|
Total Sample Size="290"
Sample Size from India="290"
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)
|
15/05/2024 |
| 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="2"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
There is an abundance of studies pertaining to the factors associated with morbidity and mortality in patients of schizophrenia and depression, however the members of the family who care for the patient principally, seem to not be given an apropos modicum of scientific and rigorous attention vis-Ã -vis research. Needless to say, there is a dearth of studies making a direct comparison of the strain sustained by caregivers in the psychiatric illnesses mentioned above, even though they are two of the most common and prevalent conditions attended to by psychiatrists. And lesser still are the number of studies of the above mentioned issue which address these illnesses in the Indian context. By undertaking the current study, the researchers intend not only to understand and compare, but also elucidate the changes that occur, burden imposed and stresses perceived by the caregivers of individuals suffering from schizophrenia and those suffering from depression. |