| CTRI Number |
CTRI/2024/04/064949 [Registered on: 01/04/2024] Trial Registered Prospectively |
| Last Modified On: |
26/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Quality of life and coping strategies among caregivers |
|
Scientific Title of Study
|
Quality of life and Coping strategies among caregivers of children with Intellectual disabilities in Bantwal |
| 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 Amritha Sindhu D Jalageri |
| Designation |
Post Graduate Student |
| Affiliation |
K. S. Hegde Medical Academy |
| Address |
Department of Public Health
K. S. Hegde Medical Academy
Nitte (Deemed to be University)
Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9632158022 |
| Fax |
|
| Email |
amrithasindhu95@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. MACKWIN D’MELLO |
| Designation |
Associate Professor |
| Affiliation |
K. S. Hegde Medical Academy |
| Address |
Department of Public Health
K. S. Hegde Medical Academy
Nitte (Deemed to be University)
Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9844460590 |
| Fax |
|
| Email |
mackwin@nitte.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr. MACKWIN D’MELLO |
| Designation |
Associate Professor |
| Affiliation |
K. S Hegde Medical Academy |
| Address |
Department of of Public Health K. S. Hegde Medical Academy
Nitte (Deemed to be University)
Deralakatte, Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
09844460590 |
| Fax |
|
| Email |
mackwin@nitte.edu.in |
|
|
Source of Monetary or Material Support
|
| K. S. Hegde Medical Academy
Nitte (Deemed to be University) Deralakatte, Mangaluru |
|
|
Primary Sponsor
|
| Name |
Dr Amritha Sindhu D Jalageri |
| Address |
Shivam Nilaya
Mudipu Kurnadu Bantwal Taluk
Dakshina Kannada
Karnataka, India
574153 |
| Type of Sponsor |
Other [Principal Investigator] |
|
|
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 Amritha Sindhu D Jalageri |
Department of Public Health |
K. S. HEGDE MEDICAL ACADEMY, NITTE (DEEMED TO BE UNIVERSITY),
DERALAKATTE, MANGALURU
Dakshina Kannada
KARNATAKA |
9632158022
amrithasindhu95@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| K. S Hegde Medical Academy, Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Caregivers of children with Intellectual Disabilities |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Anyone who is with the child for more than 6 months |
|
| ExclusionCriteria |
| Details |
paid caretaker who is not the family member |
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Quality of Life Score
Coping strategy
Factors associated with Quality of Life |
Two Months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Factors determining Quality of life |
two months |
|
|
Target Sample Size
|
Total Sample Size="228"
Sample Size from India="228"
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)
|
03/04/2024 |
| 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="2"
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
|
This study is been done for
determining Quality of life and Coping strategies, can help determine which
methods are most effective in managing the unique stressors caregivers face.
This knowledge can help develop skills training programs, support groups and
interventions to help caregivers better manage their role. |