| CTRI Number |
CTRI/2025/09/094247 [Registered on: 04/09/2025] Trial Registered Prospectively |
| Last Modified On: |
27/01/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Qualitative Descriptive Study |
| Study Design |
Other |
|
Public Title of Study
|
“Understanding Knowledge of Fatigue and Depression After Stroke Among Patients and Caregivers”-A Qualitative descriptive study |
|
Scientific Title of Study
|
Exploring the Knowledge of Post-Stroke Fatigue and Post-Stroke Depression in Patients with Stroke and Their Caregivers: A Qualitative Descriptive Study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Khadeejath Shahila |
| Designation |
Post Graduate Student |
| Affiliation |
Yenepoya Physiotherapy College |
| Address |
Yenepoya Physiotherapy College, Naringana Deralakatte, Mangalore
Dakshina Kannada
KARNATAKA
575018
India
Yenepoya Physiotherapy College, Naringana Deralakatte, Mangalore
Dakshina Kannada
KARNATAKA
575018
India
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
7902313013 |
| Fax |
|
| Email |
Shahilagafoor56@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms Shifali |
| Designation |
Assistant Professor |
| Affiliation |
Yenepoya Physiotherapy College |
| Address |
Yenepoya Physiotherapy College, Naringana Deralakatte, Mangalore
Dakshina Kannada
KARNATAKA
575018
India
Yenepoya Physiotherapy College, Naringana Deralakatte, Mangalore
Dakshina Kannada
KARNATAKA
575018
India
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
9353899352 |
| Fax |
|
| Email |
shifalikotian@yenepoya.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Khadeejath Shahila |
| Designation |
Post Graduate Student |
| Affiliation |
Yenepoya Physiotherapy College |
| Address |
Yenepoya Phsyiotherapy College
University road, Derlakatte
Mangaluru
Yenepoya Phsyiotherapy College
University road, Derlakatte
Mangaluru
Dakshina Kannada
KARNATAKA
575018
India |
| Phone |
7902313013 |
| Fax |
|
| Email |
Shahilagafoor56@gmail.com |
|
|
Source of Monetary or Material Support
|
| Yenepoya Physiotherapy College |
|
|
Primary Sponsor
|
| Name |
Khadeejath Shahila |
| Address |
Yenepoya Phsyiotherapy College
University road, Derlakatte
Mangaluru-575018 |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Khadeejath Shahila |
Yenepoya Ayurveda Medical College and Hospital |
Physiotherapy Departemnt 4 th floor,
Naringana, Derlakatte (Post), Mangaluru, Karnataka, India - 575018
Dakshina Kannada
KARNATAKA |
7902313013
Shahilagafoor56@gmail.com |
| Khadeejath Shahila |
Yenepoya Medical College and Hospital |
Physiotherapy Department (OPD) 7th floor,
University road , Derlakatte
Mangaluru-575018
Dakshina Kannada
KARNATAKA |
7902313013
Shahilagafoor56@gmail.comp |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Yenepoya Ethics Committe -3 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G819||Hemiplegia, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Stroke Patients:
1. Diagnosed with stroke (acute, subacute, or chronic).
2. Aged 18 years or older.
3. Able to communicate in the language used for the interview (for example, English or regional language).
4. Stroke survivors at different stages:
• Acute: 0 to 7 days post stroke
• Subacute: 7 days to 6 months post stroke
• Chronic: more than 6 months post stroke
5. Willing to participate in a semi structured interview.
Caregivers:
1. Primary caregivers (family members, relatives, or friends) who are responsible for the care of the stroke patient.
2. Aged 18 years or older.
3. Able to communicate in the language used for the interview.
4. Caregivers who have been assisting the stroke patient for at least one month post stroke.
5. Willing to participate in a semi structured interview.
|
|
| ExclusionCriteria |
| Details |
Stroke Patients:
1. Patients with severe cognitive impairment or mental health conditions (for example, dementia or acute psychiatric disorders) that would prevent meaningful participation in the interview.
2. Patients unable to communicate or understand the study due to language barriers or physical limitations (for example, aphasia).
3. Patients with a history of neurological conditions unrelated to stroke.
4. Patients in the acute phase of stroke who are unable to participate due to severe medical instability.
Caregivers:
1. Caregivers who are not directly involved in providing care (for example, distant relatives or professionals).
2. Caregivers who cannot communicate or understand the study due to language barriers or physical or mental impairments.
3. Caregivers who have less than one month of caregiving experience. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess Knowledge and understanding of post-stroke fatigue and post-stroke depression among patients with stroke and their caregivers. |
At the time of the semi-structured interview (single time point).
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Nil |
Nil |
|
|
Target Sample Size
|
Total Sample Size="15"
Sample Size from India="15"
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)
|
15/09/2025 |
| 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)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
Publication Details
Modification(s)
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
This qualitative descriptive study aims to explore the knowledge of post-stroke fatigue (PSF) and post-stroke depression (PSD) among patients with stroke and their caregivers. Using semi-structured interviews, the study seeks to identify awareness, understanding, and informational gaps related to PSF and PSD. The findings may help inform the development of rehabilitation strategies and contribute to improving post-stroke care and recovery outcomes.
|