Evaluation of Caregiver Burden and Depression Severity in Patients With Hemiplegia

June 12, 2024 updated by: Serdar Kilinc, Abant Izzet Baysal University

Evaluation of Caregiver Burden and Depression Severity in Patients With Right and Left Hemiplegia

This study aimed to evaluate the caregiving burden and severity of depression in patients with right hemiplegia and left hemiplegia.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Stroke is a disease characterized by neurological symptoms and signs lasting more than 24 hours, which can lead to death after the interruption of brain blood flow or due to focal brain damage. Post-stroke disability affects the patient's quality of life, makes the patient dependent on the caregiver, creates a caregiver burden, and brings socioeconomic and social consequences. Different hemispheres of the brain undertake different tasks. Different clinical conditions may occur in stroke patients with right or left hemiplegia following cerebrovascular infarction. This may affect the care burden of caregivers and the severity of depression. It was thought that knowing the care burden of patients with right and left hemiplegia would positively contribute to the quality of care given to patients.This study aimed to evaluate the caregiving burden and severity of depression in patients with right hemiplegia and left hemiplegia.

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Bolu, Turkey, 14100
        • Abant Izzet Baysal University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Hemiplegia patients treated in our outpatient and inpatient physical therapy and rehabilitation units and their first- or second-degree relatives who care for these patients constitute the 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Right Hemiplegia
Other: Survey Study

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
Other: Survey Study

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

This is where you will find people and organizations involved with this study.

Sponsor

Abant Izzet Baysal University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2023

Primary Completion (Actual)

April 1, 2024

Study Completion (Actual)

May 1, 2024

Study Registration Dates

First Submitted

June 10, 2024

First Submitted That Met QC Criteria

June 12, 2024

First Posted (Actual)

June 13, 2024

Study Record Updates

Last Update Posted (Actual)

June 13, 2024

Last Update Submitted That Met QC Criteria

June 12, 2024

Last Verified

June 1, 2024

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)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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