Ignite Creation Date:
2025-12-24 @ 3:06 PM
Ignite Modification Date:
2026-02-26 @ 12:21 AM
Study NCT ID:
NCT02126059
Status:
COMPLETED
Last Update Posted:
2016-02-17
First Post:
2014-04-21
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Complementary Interventions on Patients With Dementia: Comparative and Longitudinal Research
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001519', 'term': 'Behavior'}], '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': ['CARE_PROVIDER']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-02-14', 'studyFirstSubmitDate': '2014-04-21', 'studyFirstSubmitQcDate': '2014-04-27', 'lastUpdatePostDateStruct': {'date': '2016-02-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-04-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'behavioral and psychological symptoms of dementia', 'timeFrame': '2 years', 'description': "To examine if patients' behavioral and psychological symptoms decrease after the intervention.\n\nChinese version of Cohen-Mansfield Agitation Inventory (CMAI) will be used to measure this outcome.\n\nData will be analyzed through GLM repeated measure-GEE."}], 'secondaryOutcomes': [{'measure': 'quality of life', 'timeFrame': '2 years', 'description': "To examine if patients' quality of life improve after the intervention. WHO Quality of Life-brief Taiwanese version (WHOQOL-BREF) will be used to measure this outcome.\n\nData will be analyzed through GLM-repeated measure-GEE."}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['dementia', 'behavioral and psychological symptoms', 'quality of life'], 'conditions': ['Dementia']}, 'referencesModule': {'references': [{'pmid': '32813272', 'type': 'DERIVED', 'citation': 'Ball EL, Owen-Booth B, Gray A, Shenkin SD, Hewitt J, McCleery J. Aromatherapy for dementia. Cochrane Database Syst Rev. 2020 Aug 19;8(8):CD003150. doi: 10.1002/14651858.CD003150.pub3.'}]}, 'descriptionModule': {'briefSummary': 'Cognitive function, behavioral and psychological symptoms, and quality of life will improve after administration of cognitive stimulation therapy, reminiscence therapy, and aroma-massage therapy in patients with dementia.', 'detailedDescription': "This study will base on the pattern of behavioral and psychological symptoms of dementia, to verify and compare the effectiveness of the three non-pharmacological complementary interventions, cognitive stimulation therapy, reminiscence therapy, and aroma-massage therapy on patients' cognitive function, behavior and psychological symptoms, and quality of life."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* been diagnosed with dementia (all stages) or MMSE below 23 for high school educated and 17 for less than high school education\n* able to communicate verbally or nonverbally\n* able to understand short sentences\n* can sit for at least 50 mins.\n\nExclusion Criteria:\n\n* no hospitalization within the past two weeks\n* not under severe acute illness\n* no psychiatric disorders.'}, 'identificationModule': {'nctId': 'NCT02126059', 'briefTitle': 'Complementary Interventions on Patients With Dementia: Comparative and Longitudinal Research', 'organization': {'class': 'OTHER', 'fullName': 'National Cheng-Kung University Hospital'}, 'officialTitle': 'The Health Effects of Cognitive Stimulation, Reminiscence, and Aroma-massage Complementary Interventions on Different Behavior Patterns of Patients With Dementia: Comparative and Longitudinal Research', 'orgStudyIdInfo': {'id': 'Sellin127'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cognitive stimulation', 'description': 'One cognitive stimulation session per week for a continuous 10 weeks, each session contains 50 minutes, totally 10 session topics related to cognitive stimulation.', 'interventionNames': ['Behavioral: Reminiscence']}, {'type': 'EXPERIMENTAL', 'label': 'Aroma-massage', 'description': 'One hand and shoulder massage session per week for a continuous 10 weeks, each session contains 30 minutes, totally 10 session massage.', 'interventionNames': ['Behavioral: Cognitive stimulation']}, {'type': 'EXPERIMENTAL', 'label': 'reminiscence', 'description': 'One reminiscence session per week for a continuous 10 weeks, each session contains 50 minutes, totally 10 session topics related to reminiscence.', 'interventionNames': ['Behavioral: Aroma-massage']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Control group remain regular activities'}], 'interventions': [{'name': 'Reminiscence', 'type': 'BEHAVIORAL', 'otherNames': ['Reminiscence complementary therapy'], 'description': 'The 10 session topics include "Happy to seeing you", "Childhood stories", "Food flavor", "Our old songs", "Festival", "My family", "My Carrier", "Unforgettable events", "My home", and "My award".\n\nsmall group intervention (8-12 per group), expected total number of group is 5.', 'armGroupLabels': ['Cognitive stimulation']}, {'name': 'Cognitive stimulation', 'type': 'BEHAVIORAL', 'description': 'The 10 session topics include "psycial activities", "sound", "face", "food", "word association", "number and games", "being creative", "categorizing objects", "orientation", and "team qiuz".\n\nsmall group intervention (8-12 per group), total number of group is 5.', 'armGroupLabels': ['Aroma-massage']}, {'name': 'Aroma-massage', 'type': 'BEHAVIORAL', 'description': 'Researcher will conduct hand and arm massage to a patient, once a week, each time session for 30 mins with natural tested and safe aroma-essential oil.', 'armGroupLabels': ['reminiscence']}]}, 'contactsLocationsModule': {'locations': [{'zip': '701', 'city': 'Tainan', 'country': 'Taiwan', 'facility': 'National Cheng Kung University Dementia center', 'geoPoint': {'lat': 22.99083, 'lon': 120.21333}}], 'overallOfficials': [{'name': 'Jing-Jy Wang, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Cheng Kung University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Cheng-Kung University Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Science and Technology Council, Taiwan', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}