| CTRI Number |
CTRI/2024/02/062528 [Registered on: 12/02/2024] Trial Registered Prospectively |
| Last Modified On: |
06/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Assessment of careburden amoung caregivers of patients with neurological disorder: A cross sectional study |
|
Scientific Title of Study
|
Assessment of Burden on Caregivers of Patients with Neurological Disorders : A 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 |
Ashwini Mistry |
| Designation |
PG student |
| Affiliation |
College of Physiotherapy Sumandeep Vidyapeeth Deemed to be University |
| Address |
PG classroom on ground floor of college of physiotherapy
sumandeep vidyapeeth deemed to be university at and post pipariya taluka waghodiya vadodara gujarat india
Vadodara
GUJARAT
391760
India |
| Phone |
9021697841 |
| Fax |
|
| Email |
ashwinimistry1899@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ashwini Mistry |
| Designation |
PG student |
| Affiliation |
College of Physiotherapy Sumandeep Vidyapeeth Deemed to be University |
| Address |
PG classroom on ground floor of college of physiotherapy
sumandeep vidyapeeth deemed to be university at and post pipariya taluka waghodiya vadodara gujarat india
Vadodara
GUJARAT
391760
India |
| Phone |
9021697841 |
| Fax |
|
| Email |
ashwinimistry1899@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr G P Kumar |
| Designation |
Dean |
| Affiliation |
College of Physiotherapy Sumandeep Vidyapeeth Deemed to be University |
| Address |
Dean Office on ground floor college of physiotherapy sumandeep vidyapeeth deemed to be university at and post pipariya taluka waghodiya vadodara gujrat india
Vadodara
GUJARAT
391760
India |
| Phone |
8238034454 |
| Fax |
|
| Email |
principal.physiotherapy@sumandeepvidyapeethdu.edu.in |
|
|
Source of Monetary or Material Support
|
| Ashwini Mistry college of physiotherapy sumandeep vidyapeeth deemed to be university |
|
|
Primary Sponsor
|
| Name |
Ashwini Mistry |
| Address |
PG classroom on ground floor of college of physiotherapy
sumandeep vidyapeeth deemed to be university at and post pipariya taluka waghodiya vadodara gujarat india |
| Type of Sponsor |
Other [Self-funded] |
|
|
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 |
| Ashwini Mistry |
Dhiraj Hospital |
General medicine ward and Neurosurgery ward sumandeep vidyapeeth deemed to be university at and post pipariya taluka waghodiya vadodara gujarat india
Vadodara
GUJARAT |
9021697841
ashwinimistry1899@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sumandeep Vidyapeeth Institutional Ethics Committee( SVIEC) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G00-G99||Diseases of the nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Both patient and caregiver of any gender of 18 year to 99 year.
Principal Caregivers of patient with neurological disorders who is staying with the hospitalised patient most of the time.
|
|
| ExclusionCriteria |
| Details |
Professional caregivers.
Caregiver who already having neurological disorder and mental illness.
|
|
|
Method of Generating Random Sequence
|
Other |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Zarit Caregiver Burden Assessment Scale (Revised,22 items) |
At baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Barthal Index |
At baseline |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="85" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/02/2024 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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 proposed study will be submitted to Sumandeep Vidyapeeth Institutional Ethical Committee (SVIEC) for ethical approval. After obtaining approval from the committee, the study will be commenced by approaching the concerned authority of Dhiraj General Hospital for taking the permission to carry out this study in the hospital. Consecutive patients with neurological disorders referred for physiotherapy treatment will be approached . Those who are willing to participate will be explained in detail about the study and written informed consent (Annexure â… ) will be taken. The participation information sheet (Annexure II) will be given to the patients and caregivers. Patients and caregivers will be screened according to the inclusion and exclusion criteria and recruitment will be done. Then complete neurological assessment of patients will be done according to Assessment format (Annexure III).The assessment of physical disability of patients will be done using Barthal index (Annexure â…£). Demographic data of the caregivers will be collected (Annexure â…¤ ) . Caregivers will be asked fill Zarit Burden Interview Scale ( Annexure â…¥ ) which will be translated to Hindi and Gujrati language . Any queries in filling ZBI will be solved by the principal investigator. If required, an one to one interview shall be conducted with the caregivers who finds difficulty to fill ZBI. Scoring will be noted according to the interpretation of scale. Results will be noted. |