Ignite Creation Date:
2025-12-25 @ 4:05 AM
Ignite Modification Date:
2025-12-26 @ 3:01 AM
Study NCT ID:
NCT05475002
Status:
COMPLETED
Last Update Posted:
2025-12-19
First Post:
2022-07-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Care Empowerment Program Using Virtual Reality for Family Caregivers of People With Dementia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D000079102', 'term': 'Empowerment'}], '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'}, {'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'two-group randomised controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 92}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-12-13', 'studyFirstSubmitDate': '2022-07-18', 'studyFirstSubmitQcDate': '2022-07-24', 'lastUpdatePostDateStruct': {'date': '2025-12-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2022-07-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dementia Knowledge Assessment Scale (DKAS)', 'timeFrame': 'baseline', 'description': 'score of knowledge about dementia'}, {'measure': 'Dementia Knowledge Assessment Scale (DKAS)', 'timeFrame': 'month 3', 'description': 'score of knowledge about dementia'}, {'measure': 'Dementia Knowledge Assessment Scale (DKAS)', 'timeFrame': 'month 4', 'description': 'score of knowledge about dementia'}, {'measure': 'Approaches to Dementia Questionnaire (ADQ)', 'timeFrame': 'baseline', 'description': 'score of attitude toward people with dementia'}, {'measure': 'Approaches to Dementia Questionnaire (ADQ)', 'timeFrame': 'month 3', 'description': 'score of attitude toward people with dementia'}, {'measure': 'Approaches to Dementia Questionnaire (ADQ)', 'timeFrame': 'month 4', 'description': 'score of attitude toward people with dementia'}, {'measure': 'Family Caregiver Competence Questionnaire (FACCQ)', 'timeFrame': 'baseline', 'description': 'score of FACCQ'}, {'measure': 'Family Caregiver Competence Questionnaire (FACCQ)', 'timeFrame': 'month 3', 'description': 'score of FACCQ'}, {'measure': 'Family Caregiver Competence Questionnaire (FACCQ)', 'timeFrame': 'month 4', 'description': 'score of FACCQ'}, {'measure': 'Revised Interpersonal Reactivity Index (R-IRI)', 'timeFrame': 'baseline', 'description': 'empathy toward people with dementia'}, {'measure': 'Revised Interpersonal Reactivity Index (R-IRI)', 'timeFrame': 'month 3', 'description': 'empathy toward people with dementia'}, {'measure': 'Revised Interpersonal Reactivity Index (R-IRI)', 'timeFrame': 'month 4', 'description': 'empathy toward people with dementia'}], 'secondaryOutcomes': [{'measure': 'Caregiver Burden Inventory (CBI)', 'timeFrame': 'baseline', 'description': 'score of caregiver burden for caring for people with dementia'}, {'measure': 'Caregiver Burden Inventory (CBI)', 'timeFrame': 'month 3', 'description': 'score of caregiver burden for caring for people with dementia'}, {'measure': 'Caregiver Burden Inventory (CBI)', 'timeFrame': 'month 4', 'description': 'score of caregiver burden for caring for people with dementia'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['family caregiver', 'dementia', 'virtual reality', 'empowerment'], 'conditions': ['Dementia Family Caregiver']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate a care empowerment program using virtual reality on dementia knowledge, attitude, self-efficacy in managing BPSD, empathy and caregiver burden of family caregivers of people with dementia.', 'detailedDescription': 'The majority of patients with dementia live at home and cared by their families in Taiwan. Most of family caregivers have limited knowledge and care skills of dementia, therefore they experience great stress and caregiver burden which may have negative impact on their physical and mental health.\n\nThis two-group randomised controlled trial aims to evaluate a care empowerment program using virtual reality on dementia knowledge, attitude, care self-efficacy in managing BPSD, empathy and caregiver burden of family caregivers of people with dementia.\n\nThe intervention group will receive the Care Empowerment Program, which consists of dementia care e-books and virtual reality-based dementia activities, in addition to the routine dementia care manual and family support group.\n\nThe control group will only receive routine dementia care manual and family support group with no dementia virtual reality activity.\n\nBoth groups will be assessed for their dementia knowledge, attitudes, self-efficacy in managing BPSD, empathy and caregiver burden at baseline, month 3, and 4.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 20 to 90 years,\n* Taiwanese nationality,\n* have provided care for relatives with dementia or cognitive impairment for at least three months,\n* have a mobile phone or tablet and regular access to the internet,\n* provide informed consent to participate in the study.\n\nExclusion Criteria:\n\n* family members who do not meet the inclusion criteria,\n* can not provide informed consent.'}, 'identificationModule': {'nctId': 'NCT05475002', 'briefTitle': 'A Care Empowerment Program Using Virtual Reality for Family Caregivers of People With Dementia', 'organization': {'class': 'OTHER', 'fullName': 'Tzu Chi University'}, 'officialTitle': 'A Randomized Controlled Trial of a Care Empowerment Program Using Virtual Reality for Family Caregivers of People With Dementia', 'orgStudyIdInfo': {'id': 'YLH-IRB-11104'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'care empowerment program', 'interventionNames': ['Other: care empowerment program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'routine family support', 'interventionNames': ['Other: Routine family support']}], 'interventions': [{'name': 'care empowerment program', 'type': 'OTHER', 'description': 'dementia care e-books and dementia virtual reality activity in addition to the routine dementia care manual and family support group', 'armGroupLabels': ['Intervention group']}, {'name': 'Routine family support', 'type': 'OTHER', 'description': 'routine dementia care manual and family support group', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '970', 'city': 'Hualien City', 'country': 'Taiwan', 'facility': 'TCU dementia day center', 'geoPoint': {'lat': 23.97694, 'lon': 121.60444}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tzu Chi University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Huei-Chuan Sung', 'investigatorAffiliation': 'Tzu Chi University'}}}}