| CTRI Number |
CTRI/2023/11/059977 [Registered on: 17/11/2023] Trial Registered Prospectively |
| Last Modified On: |
10/11/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Relationship between caregiver burden and fatigue in participants with stroke |
|
Scientific Title of Study
|
Relationship between Caregiver burden and fatigue in Stroke survivors: 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 |
Ashveya Joylin Dias |
| Designation |
Intern |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Physiotherapy, Manipal College of Health Professions, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
6360290617 |
| Fax |
|
| Email |
ashveyajoylin100@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Manikandan Natarajan |
| Designation |
Additional Professor |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Physiotherapy, Manipal College of Health Professions, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9886898064 |
| Fax |
|
| Email |
mani.kandan@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Manikandan Natarajan |
| Designation |
Additional Professor |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Physiotherapy, Manipal College of Health Professions, MAHE, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9886898064 |
| Fax |
|
| Email |
mani.kandan@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Physiotherapy, Manipal College of Health Professions, MAHE, Manipal |
|
|
Primary Sponsor
|
| Name |
Ashveya Joylin Dias |
| Address |
Department of Physiotherapy, Manipal College of Health Professions, MAHE, Manipal |
| 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 |
| Ashveya Joylin Dias |
Kasturba Medical College and Kasturba Hospital |
Neuromotor control training unit, Department of Physiotherapy, Kasturba Hospital, Udupi- Hebri road, Madhav Nagar, Manipal-576104, Udupi, Karnataka Udupi
Udupi
KARNATAKA |
6360290617
ashveyajoylin100@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee-2 (Student Research) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I63||Cerebral infarction, |
|
|
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 |
For post-stroke patients
1)Age greater than 18years.
2)Any sex.
3)Post onset stroke duration between two weeks to 2 years.
4)Individuals who report fatigue (VAFS greater than and equal to 4)
5)Able to read and comprehend Kannada/English.
6)Cognitively sound (MMSE greater than 23)
For Caregiver
1)Aged greater than 18 years.
2)Any sex.
3)Participants who can read and comprehend Kannada/English.
4)Participants who can understand simple instructions.
|
|
| ExclusionCriteria |
| Details |
For post-stroke patients
1)Individuals who also have problems affecting other systems that contribute to fatigue.
2)Individuals undergoing immune modulatory drugs.
3)Individuals who underwent surgical procedures for stroke.
4)Individuals with recurrent stroke.
5)Individuals who had pre-existing daily activity impairment before their stroke.
For caregivers
1)Individuals having communication problems.
2)Individuals taking care of more than one family members with disability.
3)Caregivers already having a disability that may influence their level of burden. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Fatigue Severity Scale
Zarit Caregiver Burden Interview |
1st: Seven days post-stroke or on the day of discharge
2nd: 1 month post discharge
3rd: 3 months post discharge |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
20/11/2023 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/11/2023 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
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
|
This study is an observational cross-sectional design. Permission to use Fatigue Severity Scale and Zarit Burden Interview scale has been obtained from the respective authors. Approval from the Institutional Research Committee MCHP MAHE and Institutional Ethics Committee Kasturba Hospital Manipal has been obtained. This study will be registered under the Clinical Trial Registry - India. Stroke survivors who are referred to the Department of Physiotherapy Kasturba Hospital Manipal and their caregivers will be screened for Inclusion and Exclusion Criteria. The selected participants will be provided with detailed instructions regarding the study procedure after which a written informed consent will be obtained. Demographic characteristics of the participants (stroke survivors and caregivers) and clinical characteristics will be documented. For assessment of caregiver burden English or Kannada version of the Zarit Caregiver Burden Interview will be administered to the caregivers. They will be asked to read the components and score from 0(never) to 4(nearly always) according to the level of burden they feel. For assessment of fatigue, English or Kannada version of the Fatigue Severity Scale will be administered to assess the level of fatigue. Participants will be asked to read the components in the scale and circle the number from 1 (strongly disagree) to 7 (strongly agree) based on how accurately it reflects their condition in the past one week. The scales will be administered to stroke survivors and caregivers post seven days of admission to the hospital or on the day of discharge in separate rooms to prevent any administration bias and data contamination. Through a telephonic interview, the participants will be reassessed for the caregiver burden and post stroke-fatigue at 1 month and 3-month post discharge. Data collected from stroke survivors and caregiver will be stored appropriately and analyzed to determine the correlation. |