Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-27 @ 10:54 PM
Study NCT ID:
NCT06040294
Status:
COMPLETED
Last Update Posted:
2025-08-01
First Post:
2023-09-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dementia and Disability Simulation for College Nursing Students' Senior Activity Facilitation Skills
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'two-group randomised controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-09-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2024-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-29', 'studyFirstSubmitDate': '2023-09-09', 'studyFirstSubmitQcDate': '2023-09-09', 'lastUpdatePostDateStruct': {'date': '2025-08-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dementia Knowledge Assessment Scale (DKAS)', 'timeFrame': 'Baseline, week 12, week 18', 'description': 'score of knowledge about dementia (0\\~50) higher scores indicate more knowledge about dementia'}, {'measure': 'Approaches to Dementia Questionnaire (ADQ)', 'timeFrame': 'Baseline, week 12, week 18', 'description': 'score of attitude toward people with dementia (19\\~95) higher scores indicate more positive attitude towards dementia'}, {'measure': 'Jefferson Scale of Empathy (JSE)', 'timeFrame': 'Baseline, week 12, week 18', 'description': 'score of empathy (20\\~140) higher scores indicate more empathy for people with dementia'}, {'measure': 'Rubrics of activity design skills for seniors', 'timeFrame': 'Baseline, week 12, week 18', 'description': 'score of activity design skills for seniors (0\\~45) higher scores indicate better skills of designing activities for seniors'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['dementia', 'disability', 'simulation', 'nursing student'], 'conditions': ['Dementia']}, 'descriptionModule': {'briefSummary': 'This study aims to evaluate the effectiveness of a dementia and disability simulation (DDS) program on dementia knowledge, attitude, empathy, and activity design skills for seniors among college nursing students.', 'detailedDescription': 'This two-group randomised controlled trial aims to evaluate the effectiveness of a dementia and disability simulation program on dementia knowledge, attitude, empathy, and activity design skills for seniors among college nursing students.\n\nThe interventional group will receive a 6-week dementia and disability simulation program of activity design for seniors.\n\nThe control group will receive 6 weeks of regular dementia course and group discussion of activity design for seniors with no dementia and disability simulation.\n\nBoth groups will be assessed for their dementia knowledge, attitude, empathy and activity design skills for seniors at baseline, week 12, and week 18.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* college nursing students with age ranged from 19 to 40 years,\n* Taiwanese nationality,\n* Sophomore and above\n* provide informed consent to participate in the study.\n\nExclusion Criteria:\n\n-college nursing students who do not meet the inclusion criteria'}, 'identificationModule': {'nctId': 'NCT06040294', 'briefTitle': "Dementia and Disability Simulation for College Nursing Students' Senior Activity Facilitation Skills", 'organization': {'class': 'OTHER', 'fullName': 'Tzu Chi University'}, 'officialTitle': 'Evaluation of a Dementia and Disability Simulation Program for Senior Activity Facilitation Skills Among College Nursing Students', 'orgStudyIdInfo': {'id': 'YLH-IRB-11210'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'dementia and disability simulation program (DDS)', 'description': 'DDS program consists of dementia virtual reality and disability simulation of activity design for seniors', 'interventionNames': ['Other: DDS program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'dementia course with no DDS', 'description': 'Regular dementia course and group discussions of activity design for seniors with no DDS', 'interventionNames': ['Other: dementia course with no DDS']}], 'interventions': [{'name': 'DDS program', 'type': 'OTHER', 'description': 'dementia virtual reality and disability simulation of activity design for seniors', 'armGroupLabels': ['dementia and disability simulation program (DDS)']}, {'name': 'dementia course with no DDS', 'type': 'OTHER', 'description': 'Regular dementia course and group discussions of activity design for seniors with no DDS', 'armGroupLabels': ['dementia course with no DDS']}]}, 'contactsLocationsModule': {'locations': [{'zip': '970', 'city': 'Hualien City', 'country': 'Taiwan', 'facility': 'Tzu Chi University', 'geoPoint': {'lat': 23.97694, 'lon': 121.60444}}], 'overallOfficials': [{'name': 'Huei-Chuan Sung, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tzu Chi University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tzu Chi University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Huei-Chuan Sung', 'investigatorAffiliation': 'Tzu Chi University'}}}}