| CTRI Number |
CTRI/2023/03/051138 [Registered on: 28/03/2023] Trial Registered Prospectively |
| Last Modified On: |
28/03/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Behavioral and attitude changes in stroke survivors after stroke. |
|
Scientific Title of Study
|
Assessment of health seeking behavior in stroke survivor: A mixed method study in selected areas of Udupi district, Karnataka, India |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dalraj Singh Bajwa |
| Designation |
Postgraduate Student |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Community Medicine
3rd floor, KASTURBA MEDICAL COLLEGE, MANIPAL MAHE MANIPAL, Tiger Cricle Madhav Nagar, Manipal Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
08391800007 |
| Fax |
|
| Email |
dalraj.aherwan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Divya Arvind Prabhu |
| Designation |
Associate professor |
| Affiliation |
Kasturba Medical College, Manipal, MAHE |
| Address |
Department of Community Medicine
3rd floor, KASTURBA MEDICAL COLLEGE, MANIPAL MAHE MANIPAL, Tiger Cricle Madhav Nagar, Manipal Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
09916281108 |
| Fax |
|
| Email |
DV.PAI@MANIPAL.EDU |
|
Details of Contact Person
Public Query
|
| Name |
Dr Divya Arvind Prabhu |
| Designation |
Associate professor |
| Affiliation |
Kasturba Medical College, Manipal, MAHE |
| Address |
Department of Community Medicine
3rd floor, KASTURBA MEDICAL COLLEGE, MANIPAL MAHE MANIPAL, Tiger Cricle Madhav Nagar, Manipal Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
09916281108 |
| Fax |
|
| Email |
DV.PAI@MANIPAL.EDU |
|
|
Source of Monetary or Material Support
|
| KASTURBA MEDICAL COLLEGE, MANIPAL MAHE MANIPAL, Tiger Cricle Madhav Nagar, Manipal Udupi 576104 Karnataka, India. |
|
|
Primary Sponsor
|
| Name |
Kasturba Medical College |
| Address |
KASTURBA MEDICAL COLLEGE, MANIPAL MAHE MANIPAL, Tiger Cricle Madhav Nagar, Manipal Udupi |
| Type of Sponsor |
Private medical college |
|
|
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 Dalraj Singh Bajwa |
Kasturba medical college |
Department of Community Medicine
3rd floor, KASTURBA MEDICAL COLLEGE, MANIPAL MAHE MANIPAL, Tiger Cricle Madhav Nagar, Manipal Udupi
Udupi
KARNATAKA |
08391800007
dalraj.aherwan@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 |
| Healthy Human Volunteers |
Stroke Survivors. |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
99.00 Year(s) |
| Gender |
Both |
| Details |
Stroke survivor with onset of stroke of more than three months
Stroke cases detected after 2017.
Those aged more than 18 years and residing in the field practice area.
Those who are willing to participate in the study and ready to provide informed consent. |
|
| ExclusionCriteria |
| Details |
Stroke survivors with aphasia where the bystander/ caregiver is not present at the time of acute stroke.
Patients diagnosed with Transient Ischemic attack (TIA)
Patient with any known pre-existing disabilities like.
Diagnosed neuromusculoskeletal conditions.
Diagnosed psychiatric illness.
Intellectual disability
Congenital disabilities
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Quantitative study:
Data will be obtained regarding the factors affecting health seeking behavior of stroke survivors and the association of health seeking behavior with stroke recovery
Qualitative study:
Facilitators and barriers for seeking health services among stroke survivors at the time of acute stroke and follow up thereafter
|
2 Years
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Facilitators and barriers for seeking health services among stroke survivors at the time of acute stroke and follow up thereafter. |
2 years |
|
|
Target Sample Size
|
Total Sample Size="260"
Sample Size from India="260"
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)
|
06/04/2023 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
Not Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Stroke is the second leading cause of death worldwide accounting for nearly 5.5 million deaths every year. The burden of stroke lies in the high mortality, but the high morbidity also results in up to 50% of survivors being chronically disabled. Whereas almost half of them suffer from long term disabilities which has detrimental effect on the physical, mental, social, and economic status of not only the stroke survivors but also their family and friends. Stroke is a disease of immense public health importance with serious economic and social consequences. The public health burden of stroke is set to rise over future decades because of demographic transitions of populations, particularly in developing countries. Quantitative study: Data will be obtained regarding the factors affecting health seeking behavior of stroke survivors and the association of health seeking behavior with stroke recovery using Predesigned questionnaire and Scales in 260 stroke survivors. Qualitative study: A minimum of 2-3 FGDs will be carried out among stroke caregivers and community health workers. One FGD will be conducted among health care providers (occupational therapist, speech therapist, neurologist, physiotherapist, AYUSH specialist). Facilitators and barriers for seeking health services among stroke survivors at the time of acute stroke and follow up thereafter.
|