Ignite Creation Date:
2025-12-24 @ 11:06 PM
Ignite Modification Date:
2025-12-25 @ 8:38 PM
Study NCT ID:
NCT06301269
Status:
RECRUITING
Last Update Posted:
2024-03-08
First Post:
2024-03-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study on Self-Compassion,Depression,and Quality of Life Among Primary Caregivers of People With Dementia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003704', 'term': 'Dementia'}], 'ancestors': [{'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'FAMILY_BASED'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-03-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-07-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-03-03', 'studyFirstSubmitDate': '2024-03-03', 'studyFirstSubmitQcDate': '2024-03-03', 'lastUpdatePostDateStruct': {'date': '2024-03-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-03-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-05-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Self-Compassion Scale', 'timeFrame': 'The participants will spend 5-10 minutes completing the questionnaire during the study', 'description': 'The self-compassion score, measured using the Self-Compassion Scale, reflects the level of self-compassion among primary caregivers of people with dementia.'}, {'measure': 'PHQ-9 Scale', 'timeFrame': 'The participants will spend 5-10 minutes completing the questionnaire during the study', 'description': 'The PHQ-9 Scale, measured using the PHQ-9 Scale, reflects the level of depression among primary caregivers of people with dementia.'}, {'measure': 'Quality-of-Life Scale', 'timeFrame': 'The participants will spend 5-10 minutes completing the questionnaire during the study', 'description': 'The Quality-of-Life Scale , measured using the Quality-of-Life Scale , reflects the level of Quality-of-Life among primary caregivers of people with dementia.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['dementia', 'self-compassion', 'Primary Caregivers'], 'conditions': ['Dementia']}, 'descriptionModule': {'briefSummary': 'The goal of this observational study is to investigate the correlation between self-compassion, depression, and quality of life among primary caregivers of persons with dementia.\n\nThe main questions it aims to answer are:\n\n1. What is the current status of self-compassion, depression, and quality of life among primary caregivers of persons with dementia?\n2. Are there differences in self-compassion, depression, and quality of life among primary caregivers of persons with dementia based on different background variables?\n3. What is the correlation between self-compassion, depression, and quality of life among primary caregivers of persons with dementia?\n\nParticipants will fill out the questionnaire to complete the study.', 'detailedDescription': 'The study design of this research is cross-sectional. The participants are primary caregivers of dementia patients diagnosed by specialists, aged 18 and above, who spend 8 hours or more daily (including overnight caregivers) providing care. Data is collected using instruments including the Self-Compassion Scale, the PHQ-9 Scale (Patient Health Questionnaire,PHQ-9）, and the Quality-of-Life Scale to investigate the relationship between self-compassion, depression, and quality of life among primary caregivers of dementia patients.\n\nThe study uses independent samples t-tests and one-way ANOVA( analysis of variance,ANOVA) to explore differences in self-compassion, depression, and quality of life among primary caregivers of dementia patients based on different background variables. Pearson correlation is used to analyze the relationships between these variables. Finally, linear regression is used to predict the performance of primary caregivers of dementia patients in self-compassion, depression, and quality of life.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study will include primary caregivers of people with dementia. Participants will be adults aged 18 years and older who are currently providing care for a family member , Participants will be recruited from NTUH Neurology ward and Out-Patient Departments (OPD).', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. primary caregivers of dementia patients diagnosed by specialists\n2. aged 18 and above\n3. who spend 8 hours or more daily (including overnight caregivers) providing care\n\nExclusion Criteria:\n\n1. Those who do not agree to participate in the research\n2. Caregivers in a paid relationship with dementia patients, such as foreign domestic helpers and government-provided resident care attendant'}, 'identificationModule': {'nctId': 'NCT06301269', 'briefTitle': 'A Study on Self-Compassion,Depression,and Quality of Life Among Primary Caregivers of People With Dementia', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'A Study on Self-Compassion,Depression,and Quality of Life Among Primary Caregivers of People With Dementia', 'orgStudyIdInfo': {'id': '202312124RINA'}}, 'armsInterventionsModule': {'interventions': [{'type': 'OTHER'}]}, 'contactsLocationsModule': {'locations': [{'zip': '100', 'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'wen lin YE', 'role': 'CONTACT', 'email': 'vovo951357@ntuh.gov.tw', 'phone': '+886-2312-3456'}], 'facility': 'National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Wen Lin Ye', 'role': 'CONTACT', 'email': 'vovo951357@ntuh.gov.tw', 'phone': '02-2312 3456', 'phoneExt': '262788'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}