Ignite Creation Date:
2025-12-24 @ 11:51 AM
Ignite Modification Date:
2025-12-31 @ 3:57 PM
Study NCT ID:
NCT06457061
Status:
COMPLETED
Last Update Posted:
2024-06-13
First Post:
2024-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Caregiver Burden and Depression Severity in Patients With Hemiplegia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006429', 'term': 'Hemiplegia'}, {'id': 'D000084802', 'term': 'Caregiver Burden'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D010243', 'term': 'Paralysis'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D013315', 'term': 'Stress, Psychological'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008137', 'term': 'Longitudinal Studies'}], 'ancestors': [{'id': 'D015331', 'term': 'Cohort Studies'}, {'id': 'D016021', 'term': 'Epidemiologic Studies'}, {'id': 'D016020', 'term': 'Epidemiologic Study Characteristics'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2024-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-06-12', 'studyFirstSubmitDate': '2024-06-10', 'studyFirstSubmitQcDate': '2024-06-12', 'lastUpdatePostDateStruct': {'date': '2024-06-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Beck's Depression Inventory", 'timeFrame': 'Day 1', 'description': '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.'}, {'measure': 'Zarit Caregiver Burden', 'timeFrame': 'Day 1', 'description': "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"}], 'secondaryOutcomes': [{'measure': 'Barthel Index for Activities of Daily Living Scale', 'timeFrame': 'Day 1', 'description': '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.'}, {'measure': 'Star Cancellation test', 'timeFrame': 'Day 1', 'description': 'The Star Cancellation Test is a screening tool developed to detect the presence of unilateral spatial neglect'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hemiplegia', 'Caregiver Burden', 'Depression']}, 'descriptionModule': {'briefSummary': 'This study aimed to evaluate the caregiving burden and severity of depression in patients with right hemiplegia and left hemiplegia.', 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Hemiplegia patients between the ages of 18 and 75 were included.\n* Caregivers over 18 years of age\n* At least 3 months must have passed since the patient was diagnosed.\n* Caregivers of patients should be their first and second degree relatives.\n* Caregivers must be competent to understand what they read and complete the questionnaires.\n* Caregivers must have been caring for their patients for at least 3 months.\n\nExclusion Criteria:\n\n* Patients and caregivers with a history of psychiatric illness'}, 'identificationModule': {'nctId': 'NCT06457061', 'briefTitle': 'Evaluation of Caregiver Burden and Depression Severity in Patients With Hemiplegia', 'organization': {'class': 'OTHER', 'fullName': 'Abant Izzet Baysal University'}, 'officialTitle': 'Evaluation of Caregiver Burden and Depression Severity in Patients With Right and Left Hemiplegia', 'orgStudyIdInfo': {'id': 'AIBU-FTR-SK-06'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Right Hemiplegia', 'interventionNames': ['Other: Survey Study']}, {'label': 'Left Hemiplegia', 'interventionNames': ['Other: Survey Study']}], 'interventions': [{'name': 'Survey Study', 'type': 'OTHER', 'description': 'Barthel Index for Activities of Daily Living Scale, Beck Depression Inventory and Star Cancellation Test questionnaires were applied to hemiplegia patients.\n\nBeck Depression Inventory and Zarit Caregiver Burden Interview surveys were administered to caregivers.', 'armGroupLabels': ['Left Hemiplegia', 'Right Hemiplegia']}]}, 'contactsLocationsModule': {'locations': [{'zip': '14100', 'city': 'Bolu', 'country': 'Turkey (Türkiye)', 'facility': 'Abant Izzet Baysal University', 'geoPoint': {'lat': 40.73583, 'lon': 31.60611}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Abant Izzet Baysal University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant professor', 'investigatorFullName': 'Serdar Kilinc', 'investigatorAffiliation': 'Abant Izzet Baysal University'}}}}