| CTRI Number |
CTRI/2024/03/063660 [Registered on: 06/03/2024] Trial Registered Prospectively |
| Last Modified On: |
28/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Association between strain on informal caregiver and quality of life of stroke patient |
|
Scientific Title of Study
|
Correlation between strain on informal caregiver and quality of life of stroke patient |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Subrat Tripathi |
| Designation |
PG Scholar |
| Affiliation |
Amity Institute of Health Allied Sciences |
| Address |
F-1 Block Lower Ground Floor, Amity Institute Of Health Allied Sciences,Amity University Noida Uttar Pradesh Sector-125 Noida 201301
Gautam Buddha Nagar
UTTAR PRADESH
201313
India |
| Phone |
8004073441 |
| Fax |
|
| Email |
Subrattripathi782728@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Neha Gupta |
| Designation |
Associate professor |
| Affiliation |
Amity Institute of health allied sciences |
| Address |
F-1 Block Lower Ground Floor, Amity Institute Of Health Allied Sciences,Amity University Noida Uttar Pradesh Sector-125 Noida 201301
Gautam Buddha Nagar
UTTAR PRADESH
201313
India |
| Phone |
9810280418 |
| Fax |
|
| Email |
ngupta4@amity.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Neha Gupta |
| Designation |
Associate professor |
| Affiliation |
Amity Institute of health allied sciences |
| Address |
F-1 Block Lower Ground Floor, Amity Institute Of Health Allied Sciences,Amity University Noida Uttar Pradesh Sector-125 Noida 201301
Gautam Buddha Nagar
UTTAR PRADESH
201313
India |
| Phone |
9810280418 |
| Fax |
|
| Email |
ngupta4@amity.edu |
|
|
Source of Monetary or Material Support
|
| Neuro Rehab- Dr. Krishan Mohan Physiotherapy Clinic |
|
|
Primary Sponsor
|
| Name |
Subrat Tripathi |
| Address |
Amity Institute of Health Allied Sciences, Amity University Noida Uttar Pradesh |
| Type of Sponsor |
Other [Self] |
|
|
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 Krishan Mohan |
Neuro Rehab- Dr. Krishan Mohan Physiotherapy Clinic |
Room no.-101,C-74,Block C,Sector 100,Noida
Gautam Buddha Nagar
UTTAR PRADESH |
9899938240
drkrishanmohanpt@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| Neuro Rehab- Dr. Krishan Mohan Physiotherapy Clinic |
No Objection Certificate |
| NTCC committee Amity Institute of Health Allied Sciences , Amity University Uttar Pradesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G811||Spastic hemiplegia, |
|
|
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 |
1) Stroke Survivor: Participants must be individuals who have been diagnosed with a stroke.
2) Family Involvement: Participants should have family members(e.g., spouses, children, caregivers) actively involved in their care.
3) Consent: Participants or their legal representatives must provide informed consent to participate in the study.
4) Health Status: Participants should be stable in terms of their medical condition at the time of enrollment to minimize confounding variables.
5) 6 Months of stroke
6) Care taker must be in good health
7) Both caregivers and stroke patients should be willing and able to participate in the study |
|
| ExclusionCriteria |
| Details |
1) Other Significant Medical Conditions: Individuals with severe, uncontrolled comorbid medical conditions apart from stroke may be excluded.
2) Cognitive Impairment: Participants with severe cognitive impairments that prevent them from engaging in the activity.
3) Language Barrier: Those who do not have sufficient language skills to understand the educational materials may be excluded.
4) Lack of Family Involvement: If there is no active family involvement in the care of the stroke survivor, these individuals
might be excluded.
5) Unwillingness to Participate: Individuals who decline to provide informed consent or actively refuse participation are typically excluded.
6) Other Research Participation: Participants currently involved in other conflicting research studies may be excluded to avoid data contamination.
7) Caregivers with severe psychological or physical health conditions that may interfere with their ability to participate.
8) Patients or caregivers who have experienced recent major life events that could significantly impact their quality of life or caregiving burden (e.g., recent bereavement, divorce, etc.). |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Zarit caregiver burden assessment.
5 dimensions of SF-36 |
1 time |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Stroke specific quality of life (SSQOL) |
1 time |
|
|
Target Sample Size
|
Total Sample Size="44"
Sample Size from India="44"
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)
|
09/03/2024 |
| 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="1"
Months="0"
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 aims to study the relationship between caregiver burden and stroke patient quality of life. One of the most important aspects of stroke treatment and management is the relationship between carer stress and the quality of life of stroke patients. The quality of life and carer burden of stroke survivors are measured using multiple scales. Zarit Caregiver Burden Assessment Scale: This scale is frequently used to gauge the degree of load that carers bear, including financial, physical, and emotional strain. Conversely, quality of life assessments tailored specifically for stroke victims, like the Stroke-Specific Quality of Life Scale (SS-QOL), offer valuable information about the distinct life domains impacted by stroke, such as the physical, psychosocial, and cognitive domains. Furthermore, a popular tool for evaluating many aspects of quality of life, such as social functioning, emotional stability, and physical functioning, is the SF-36 Quality of Life Scale. With this study the relationship between carer stress and stroke patient’s quality of life will be examined and correlation will observed. |