Ignite Creation Date:
2025-12-25 @ 2:44 AM
Ignite Modification Date:
2025-12-30 @ 11:43 AM
Study NCT ID:
NCT04507633
Status:
COMPLETED
Last Update Posted:
2022-03-21
First Post:
2020-07-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ROMA (Reminiscence, Reality Orientation, Music and Art ) Therapy, Cognition, Depression and Behavioral Problems in the Population 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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D027724', 'term': 'Reproductive Techniques, Assisted'}], 'ancestors': [{'id': 'D012099', 'term': 'Reproductive Techniques'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'independent researchers will perform intervention and data collection.'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 45}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-08-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2021-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-18', 'studyFirstSubmitDate': '2020-07-25', 'studyFirstSubmitQcDate': '2020-08-09', 'lastUpdatePostDateStruct': {'date': '2022-03-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'cognitive functions', 'timeFrame': 'cognitive functions at baseline', 'description': 'Short Portable Mental Status Questionnaire(SPMSQ)'}, {'measure': 'cognitive functions', 'timeFrame': 'cognitive functions after the completion of intervention', 'description': 'Short Portable Mental Status Questionnaire(SPMSQ)'}, {'measure': 'cognitive functions', 'timeFrame': 'cognitive functions at 4 weeks after the completion of intervention', 'description': 'Short Portable Mental Status Questionnaire(SPMSQ)'}, {'measure': 'depressive symptoms', 'timeFrame': 'depressive symptoms at baseline', 'description': 'Cornell Scale for Depression in Dementia(CSDD)'}, {'measure': 'depressive symptoms', 'timeFrame': 'depressive symptoms after the completion of intervention', 'description': 'Cornell Scale for Depression in Dementia(CSDD)'}, {'measure': 'depressive symptoms', 'timeFrame': 'depressive symptoms at 4 weeks after the completion of intervention', 'description': 'Cornell Scale for Depression in Dementia(CSDD)'}, {'measure': 'behavioral problems', 'timeFrame': 'behavioral problems at baseline', 'description': 'Neuropsychiatric Inventory-Questionnaire(NPI-Q)'}, {'measure': 'behavioral problems', 'timeFrame': 'behavioral problems after the completion of intervention', 'description': 'Neuropsychiatric Inventory-Questionnaire(NPI-Q)'}, {'measure': 'behavioral problems', 'timeFrame': 'behavioral problems at 4 weeks after the completion of intervention', 'description': 'Neuropsychiatric Inventory-Questionnaire(NPI-Q)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dementia']}, 'referencesModule': {'references': [{'pmid': '36495795', 'type': 'DERIVED', 'citation': 'Tz-Han L, Wan-Ru W, I-Hui C, Hui-Chuan H. Reminiscence music intervention on cognitive, depressive, and behavioral symptoms in older adults with dementia. Geriatr Nurs. 2023 Jan-Feb;49:127-132. doi: 10.1016/j.gerinurse.2022.11.014. Epub 2022 Dec 8.'}]}, 'descriptionModule': {'briefSummary': 'This study aimed to conduct a randomized controlled trial to examine the effectiveness of ROMA therapy( Reminiscence, Reality Orientation, Music, and Art) on improving cognitive function, behavioral and psychological symptoms in population with dementia. The hypotheis of this study is that these patients with dementia receiving ROMA therapy featuring reminiscence, reality orientation, music, and art would improve their cognition, depressive symptoms, and behavioral symptoms.', 'detailedDescription': 'This study aimed to conduct a randomized controlled trial to examine the effectiveness of ROMA therapy( Reminiscence, Reality Orientation, Music, and Art) on improving cognitive function, behavioral and psychological symptoms in demented population. A total of 60 patients with mild to moderate dementia will be recruited and randomly assigned to two groups: experimental group and control group. The experimental group will undergo ROMA therapy with a 60 minute per week for eight weeks. The control group will receive three times ROMA therapy after completing outcome measurements. Two groups will receive questionnaire interview at pre-test, post-test, and at 4 weeks after intervention. The measurements comprises: Short Portable Mental Status Questionnaire(SPMSQ), Cornell Scale for Depression in Dementia(CSDD),and Neuropsychiatric Inventory-Questionnaire(NPI-Q). By identifying the effectiveness of ROMA therapy, suitable intervention can be suggested for those demented population to improve cognitive function, behavioral and psychological symptoms.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Been diagnosed as mild to moderate dementia and CDR score between 0.5\\~2\n2. can communicate in Chinese or Taiwanese\n3. without visual or auditory impairment after equipping assist devices\n\nExclusion Criteria:\n\n1. severe dementia and Clinical Dementia Rating (CDR) score more than 2 points\n2. functional dependence\n3. incapable of expressing their feelings'}, 'identificationModule': {'nctId': 'NCT04507633', 'briefTitle': 'ROMA (Reminiscence, Reality Orientation, Music and Art ) Therapy, Cognition, Depression and Behavioral Problems in the Population With Dementia', 'organization': {'class': 'OTHER', 'fullName': 'Taipei Medical University'}, 'officialTitle': 'The Effect of ROMA Therapy on Improving Cognitive Functions, Depressive Symptoms and Behavioral Problems in the Population With Dementia', 'orgStudyIdInfo': {'id': 'N202005108'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ROMA therapy', 'description': 'ROMA therapy combines four elements including reminiscence, reality orientation, music, and art in the intervention.', 'interventionNames': ['Behavioral: ROMA therapy(reminiacence therpy, orientation, music, and art)']}, {'type': 'NO_INTERVENTION', 'label': 'control group', 'description': 'usual care'}], 'interventions': [{'name': 'ROMA therapy(reminiacence therpy, orientation, music, and art)', 'type': 'BEHAVIORAL', 'description': 'An intervention comprising reminiscence of annual festivals, orientation, and familiar music listening and singing, and animation interaction to improve cognitive functions, depressive symptoms and behaviors problems.', 'armGroupLabels': ['ROMA therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '234', 'city': 'New Taipei City', 'country': 'Taiwan', 'facility': 'Yonghe Zhongxing Public Seniors Center', 'geoPoint': {'lat': 25.06199, 'lon': 121.45703}}], 'overallOfficials': [{'name': 'Hui-Chuan Huang, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'School of Nursing, Taipei Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taipei Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Huang, Hui-Chuan', 'investigatorAffiliation': 'Taipei Medical University'}}}}