Ignite Creation Date:
2025-12-25 @ 12:28 AM
Ignite Modification Date:
2025-12-25 @ 10:34 PM
Study NCT ID:
NCT00824967
Status:
TERMINATED
Last Update Posted:
2012-03-26
First Post:
2009-01-16
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Non Pharmacological Management of Behavioural Symptoms in Nursing Home
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}], 'ancestors': [{'id': 'D003704', 'term': 'Dementia'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D024801', 'term': 'Tauopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 306}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-01', 'completionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-23', 'studyFirstSubmitDate': '2009-01-16', 'studyFirstSubmitQcDate': '2009-01-16', 'lastUpdatePostDateStruct': {'date': '2012-03-26', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-01-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes at the behavioural assessment (CMAI, OS, NPI) after 8 weeks of intervention', 'timeFrame': '8 weeks after intervention'}], 'secondaryOutcomes': [{'measure': 'Changes at the behavioural assessment (CMAI, OS, NPI) 16 weeks after the end of the intervention', 'timeFrame': '16 weeks after intervention'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['ALZHEIMER Disease']}, 'descriptionModule': {'briefSummary': 'Background: Behavioural and psychological symptoms of dementia (BPSD) are often reported in institutions for the elderly.\n\nObjective: To evaluate the effectiveness of a staff education intervention to manage BPSD in older people with a diagnosis of dementia.', 'detailedDescription': "Background: Behavioural and psychological symptoms of dementia (BPSD) are often reported in institutions for the elderly.\n\nObjective: To evaluate the effectiveness of a staff education intervention to manage BPSD in older people with a diagnosis of dementia.\n\nMethods: The trial was conducted in 16 nursing homes; 306 patients with a diagnosis of dementia and presenting BPSD were selected. Nursing homes were randomly allocated to an intervention group or a control group. An eight-week staff education and training programme was conducted in the nursing homes in the intervention group. The main outcome measures were the Cohen-Mansfield Agitation Inventory (CMAI) and an observation scale score. Assessments were done at baseline (W0), at the end of the 'intervention' period (W8) and 12 weeks after (W20)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '60 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Alzheimer disease\n\nExclusion Criteria:\n\n* Not alzheimer disease'}, 'identificationModule': {'nctId': 'NCT00824967', 'briefTitle': 'Non Pharmacological Management of Behavioural Symptoms in Nursing Home', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Universitaire de Nice'}, 'officialTitle': 'Not Pharmacologic Treatment Has Illness of Alzheimer and Pathologies Related. Application in Disturbances of Behaviour in EHPAD', 'orgStudyIdInfo': {'id': '07-PP-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': '1- The reference group', 'description': 'one will take care of the patient in a habitual way: no consultation additional, step of exam on top of that...'}, {'type': 'OTHER', 'label': '2- The intervention group', 'description': 'Training and valuation of the treating personnel', 'interventionNames': ['Other: Training and valuation of the treating personnel']}], 'interventions': [{'name': 'Training and valuation of the treating personnel', 'type': 'OTHER', 'description': 'Training and valuation of the treating personnel', 'armGroupLabels': ['2- The intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06001', 'city': 'Nice', 'state': 'Alpes-Maritimes', 'country': 'France', 'facility': 'CHU de Nice - 4 avenue Reine Victoria', 'geoPoint': {'lat': 43.70313, 'lon': 7.26608}}], 'overallOfficials': [{'name': 'Philippe ROBERT, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHU de Nice - CM2R - Hôpital de Cimiez - 4 avenue reine victoria - 06 003 Nice cedex 1'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Universitaire de Nice', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}