Ignite Creation Date:
2025-12-25 @ 1:21 AM
Ignite Modification Date:
2025-12-30 @ 4:47 PM
Study NCT ID:
NCT01382693
Status:
COMPLETED
Last Update Posted:
2012-07-04
First Post:
2011-06-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Involvement in a Group-based Creative Expression Program on Psychotropic Drug Use in Persons With Dementia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}], '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': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-03', 'studyFirstSubmitDate': '2011-06-24', 'studyFirstSubmitQcDate': '2011-06-24', 'lastUpdatePostDateStruct': {'date': '2012-07-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-06-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rates of psychotropic drug prescriptions for study participants.', 'timeFrame': 'eight months'}], 'secondaryOutcomes': [{'measure': 'Mood and behavior patterns', 'timeFrame': 'eight months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Behavioral symptoms', 'Long-term care'], 'conditions': ['Dementia']}, 'descriptionModule': {'briefSummary': 'This project, a small-scale pilot study, will attempt to determine if involvement in a group-based creative expression program may correlate with a reduction in use of psychotropic drugs for persons with dementia.', 'detailedDescription': 'The study site has two skilled-nursing dementia Special Care Units. One unit will serve as a control with residents receiving the standard care activity program. The other unit will receive the standard care activity program as well as the TimeSlips storytelling program (two hour-long sessions per week for six weeks). The behavioral symptoms and psychotropic drug usage for both cohorts will be studied for eight months, the first four months with no intervention and the last four months with or without the six-week TimeSlips intervention.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* residence in one of two dementia special-care skilled nursing units at the study site\n* clinical diagnosis of dementia'}, 'identificationModule': {'nctId': 'NCT01382693', 'briefTitle': 'Effects of Involvement in a Group-based Creative Expression Program on Psychotropic Drug Use in Persons With Dementia', 'organization': {'class': 'OTHER', 'fullName': 'Milton S. Hershey Medical Center'}, 'officialTitle': 'Effects of Involvement in a Group-based Creative Expression Program on Psychotropic Drug Use in Persons With Dementia in Long-term Care: a Cluster-randomized Pilot Study', 'orgStudyIdInfo': {'id': '36459 EP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TimeSlips group storytelling program', 'interventionNames': ['Behavioral: TimeSlips']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard care activity program', 'interventionNames': ['Behavioral: Standard care activity program']}], 'interventions': [{'name': 'TimeSlips', 'type': 'BEHAVIORAL', 'otherNames': ['creative expression program', 'storytelling program'], 'description': 'TimeSlips is a group-based creative storytelling program for people with dementia. The intervention will be held twice a week for six weeks, in hour-long sessions.', 'armGroupLabels': ['TimeSlips group storytelling program']}, {'name': 'Standard care activity program', 'type': 'BEHAVIORAL', 'description': "Standard-of-care activities for the study site's skilled-nursing dementia Special Care Units.", 'armGroupLabels': ['Standard care activity program']}]}, 'contactsLocationsModule': {'locations': [{'zip': '17543', 'city': 'Lititz', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Landis Homes', 'geoPoint': {'lat': 40.15732, 'lon': -76.3069}}], 'overallOfficials': [{'name': 'Winona S Houser, BA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Penn State College of Medicine, Penn State Milton S. Hershey Medical Center'}, {'name': 'Daniel R George, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Penn State College of Medicine, Penn State Milton S. Hershey Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Milton S. Hershey Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medical Student', 'investigatorFullName': 'Winona Houser', 'investigatorAffiliation': 'Milton S. Hershey Medical Center'}}}}