Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2025-12-27 @ 9:10 AM
Study NCT ID:
NCT04788992
Status:
COMPLETED
Last Update Posted:
2025-08-06
First Post:
2021-03-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dementia Care Training With Virtual Reality and Support for Home Care Staff
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'two-group cluster randomised controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 124}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-03-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2021-10-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-31', 'studyFirstSubmitDate': '2021-03-02', 'studyFirstSubmitQcDate': '2021-03-04', 'lastUpdatePostDateStruct': {'date': '2025-08-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dementia Knowledge Assessment Scale', 'timeFrame': '6 months', 'description': "To evaluate care staff's knowledge of dementia, range from 0-50"}, {'measure': 'Approach to Dementia Questionnaire', 'timeFrame': '6 moths', 'description': "To evaluate care staff's attitude toward Dementia, range from 19-95"}, {'measure': 'Sense of Competence in Dementia Care Staff Scale', 'timeFrame': '6 months', 'description': "To evaluate care staff's competence of caring for people with dementia, range from 16-68"}, {'measure': 'Jefferson Scale of Empathy', 'timeFrame': '6 months', 'description': "To evaluate care staff's level of empathy toward patients, score range from 20-140"}], 'secondaryOutcomes': [{'measure': 'Simple Work Stress Scale', 'timeFrame': '6 moths', 'description': 'To evaluate level of work stress of care staff'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Home care staff', 'dementia care', 'virtual reality'], 'conditions': ['Dementia']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate a dementia care training with virtual reality and peer support program on dementia care knowledge, attitude, care competence, work stress, and empathy of home care staff.', 'detailedDescription': 'Home care staff often have insufficient knowledge and skills of caring people with dementia at home. Many lack empathy for those with dementia. Training courses for home care staff often are not developed according to their educational background and workplace needs.\n\nThis two-group cluster randomised controlled trial aims to evaluate a dementia care training with virtual reality and peer support program on dementia care knowledge, attitude, care competence, work stress, and empathy of home care staff.\n\nThe dementia care training consists of dementia care e-books, dementia virtual reality activity and peer support program.\n\nThe interventional group will receive a dementia care training using dementia care e-books, dementia virtual reality activity and peer support program.\n\nThe control group will only receive dementia care e-books and peer support with no dementia virtual reality activity.\n\nBoth groups will be assessed for their dementia care knowledge, attitudes, care competence, work stress and empathy at baseline, month 3, and 6.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age 20 to 65 years\n* Taiwanese nationality\n* had worked as a home care staff for at least three months\n* had experience in providing home care for patients with dementia\n* had a mobile phone or tablet and regular access to the internet\n\nExclusion Criteria:\n\n* Home care staff who do not meet the inclusion criteria\n* can not provide informed consent.'}, 'identificationModule': {'nctId': 'NCT04788992', 'briefTitle': 'Dementia Care Training With Virtual Reality and Support for Home Care Staff', 'organization': {'class': 'OTHER', 'fullName': 'Tzu Chi University'}, 'officialTitle': 'Evaluation of a Dementia Care Training With Virtual Reality and Support Program for Home Care Staff', 'orgStudyIdInfo': {'id': 'YLH-IRB-10815'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention group', 'description': 'receive dementia care training', 'interventionNames': ['Other: Intervention group']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'receive dementia care training without virtual reality activity', 'interventionNames': ['Other: Control group']}], 'interventions': [{'name': 'Intervention group', 'type': 'OTHER', 'description': 'Dementia care training consists of dementia care e-books, dementia virtual reality activity and peer support program.', 'armGroupLabels': ['Intervention group']}, {'name': 'Control group', 'type': 'OTHER', 'description': 'Dementia care training consists of dementia care e-books and peer support program without dementia virtual reality activity', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '970', 'city': 'Hualien City', 'country': 'Taiwan', 'facility': 'Mennonite Social Welfare foundation', 'geoPoint': {'lat': 23.97694, 'lon': 121.60444}}], 'overallOfficials': [{'name': 'Huei-Chuan Sung, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tzu Chi University'}]}, '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'}}}}