- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06457061
Evaluation of Caregiver Burden and Depression Severity in Patients With Hemiplegia
Evaluation of Caregiver Burden and Depression Severity in Patients With Right and Left Hemiplegia
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Bolu, Turkey, 14100
- Abant Izzet Baysal University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Hemiplegia patients between the ages of 18 and 75 were included.
- Caregivers over 18 years of age
- At least 3 months must have passed since the patient was diagnosed.
- Caregivers of patients should be their first and second degree relatives.
- Caregivers must be competent to understand what they read and complete the questionnaires.
- Caregivers must have been caring for their patients for at least 3 months.
Exclusion Criteria:
- Patients and caregivers with a history of psychiatric illness
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Right Hemiplegia
|
Barthel Index for Activities of Daily Living Scale, Beck Depression Inventory and Star Cancellation Test questionnaires were applied to hemiplegia patients. Beck Depression Inventory and Zarit Caregiver Burden Interview surveys were administered to caregivers. |
|
Left Hemiplegia
|
Barthel Index for Activities of Daily Living Scale, Beck Depression Inventory and Star Cancellation Test questionnaires were applied to hemiplegia patients. Beck Depression Inventory and Zarit Caregiver Burden Interview surveys were administered to caregivers. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Beck's Depression Inventory
Time Frame: Day 1
|
The Beck Depression Inventory (BDI) is a 21-item, self-report rating inventory that measures characteristic attitudes and symptoms of depression.
The score to be received varies between 0-63.
A high total score indicates a higher severity of depression.
|
Day 1
|
|
Zarit Caregiver Burden
Time Frame: Day 1
|
Zarit caregiver burden interview evaluates caregivers' caregiving burden.
It consists of 22 questions.
A minimum of 0 and a maximum of 88 points can be obtained from the scale.
A A high total score indicates a higher severity of caregiver burden
|
Day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Barthel Index for Activities of Daily Living Scale
Time Frame: Day 1
|
The Barthel index is used to assess activities of daily living.
It consists of 10 items: feeding, bathing, grooming, dressing, bowel, bladder, toilet use, transfers, mobility, stairs.
Scores range from 0-100.
A score of 100 represents complete independence, and a score of 0 represents complete dependence.
|
Day 1
|
|
Star Cancellation test
Time Frame: Day 1
|
The Star Cancellation Test is a screening tool developed to detect the presence of unilateral spatial neglect
|
Day 1
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- AIBU-FTR-SK-06
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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