| CTRI Number |
CTRI/2024/11/077339 [Registered on: 25/11/2024] Trial Registered Prospectively |
| Last Modified On: |
24/11/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Factors Affecting Stroke Patients, Families, and Doctors During Treatment |
|
Scientific Title of Study
|
Assessing the Barriers and Facilitators for Rehabilitation and Post-Stroke Recovery Among Stroke Survivors, Caregivers, and Healthcare Providers |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kirthinath Ballala |
| Designation |
Associate Professor, Community Medicine |
| Affiliation |
|
| Address |
Room No. N/A, 3rd Floor,
Community Medicine Department Kasturba Medical College, Tiger Circle Road, Madhav Nagar, Eshwar Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9844270050 |
| Fax |
|
| Email |
kirthinath.ballala@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Chythra R Rao |
| Designation |
Additional Professor, Community Medicine |
| Affiliation |
Kasturba Medical College |
| Address |
Room no. N/A, 3rd Floor, Community Medicine Department, Kasturba Medical College, Tiger Circle Road, Madhav Nagar, Eshwar Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
919448857793 |
| Fax |
|
| Email |
chythra.raj@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Chythra R Rao |
| Designation |
Additional Professor, Community Medicine |
| Affiliation |
Kasturba Medical College |
| Address |
Room no. N/A, 3rd Floor, Community Medicine Department, Kasturba Medical College, Tiger Circle Road, Madhav Nagar, Eshwar Nagar, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
919448857793 |
| Fax |
|
| Email |
chythra.raj@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Kasturba Medical College
Tiger Circle Road, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka, India 576104 |
|
|
Primary Sponsor
|
| Name |
Kirthinath Ballala |
| Address |
3rd Floor, Community Medicine Department, Tiger Circle Road, Madhav Nagar, Eshwar Nagar, Manipal, Karnataka 576104 |
| 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 Kirthinath Ballala |
Kasturba Medical College |
3rd Floor, Community Medicine, Kasturba Medical College, Tiger Circle Road, Madhav Nagar, Eshwar Nagar, Manipal
Udupi
KARNATAKA |
09844270050
kirthinath.ballala@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Caregivers and Healthcare Providers of Stroke Survivors |
| Patients |
(1) ICD-10 Condition: I61||Nontraumatic intracerebral hemorrhage, (2) ICD-10 Condition: I60||Nontraumatic subarachnoid hemorrhage, (3) 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 |
Stroke Survivors
i. Able to provide consent (written or thumb impression)
ii. Experienced an ischemic or hemorrhagic stroke between 6 months to 36
months prior to enrollment
iii. Admitted to Kasturba Hospital after experiencing a stroke
iv. Able to travel to the hospital to complete the questionnaires and interview
v. 18 years and older
Caregivers
i. Able to provide consent (written or thumb impression)
ii. Family member/caregiver to someone who has experienced a stroke between 6 months to 36 months prior to enrollment
iii. Family member/primary caregiver to someone who was admitted for a stroke at Kasturba Hospital
iv. Able to travel to the hospital to complete the interview
v. 18 years and older
Healthcare Providers
i. 3 years of experience treating stroke survivors
ii. Treated someone who has experienced a stroke between 6 months to 36 months prior to enrollment |
|
| ExclusionCriteria |
| Details |
Stroke Survivors
i. Unable to communicate in English or Kannada
ii. Prior stroke
iii. Neurological condition that impacts their mobility
Caregivers
i. A family member/caregiver not permanently residing with the stroke survivor
ii. Unable to communicate in English or Kannada |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
Phase 2:
Identify the coping mechanisms employed by stroke survivors and their caregivers
Identify facilitators and barriers impacting stroke survivors and caregivers
Assess the perspectives of healthcare providers
Phase 3:
Types of barriers and facilitators faced by stroke survivors and caregivers
Association between barriers/facilitators and sociodemographic factors and stroke severity
|
Phase 2: Dec to Feb
Phase 3: Feb to May |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| None |
None |
|
|
Target Sample Size
|
Total Sample Size="148"
Sample Size from India="148"
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)
|
09/12/2024 |
| 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="7"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Open to Recruitment |
| 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
|
With a diverse population of 1.4 billion people and a growing double burden of disease, India provides the unique opportunity to examine how individuals with disabilities navigate their community and medical care. In India, stroke is the fifth leading cause of disability. Stroke affects individuals differently, and rehabilitation is critical to restoring motor function and independence. This is a cross-sectional, mixed methods study that aims to explore the various barriers and facilitators involved in post-stroke recovery. The goal of this research is to provide information that can guide public policy and post-stroke recovery tools |