Ignite Creation Date:
2025-12-25 @ 12:35 AM
Ignite Modification Date:
2025-12-25 @ 10:43 PM
Study NCT ID:
NCT00259467
Status:
COMPLETED
Last Update Posted:
2010-08-25
First Post:
2005-11-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Project TAP: Tailored Activities Project
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000544', 'term': 'Alzheimer Disease'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D003704', 'term': 'Dementia'}], 'ancestors': [{'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'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2004-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-08', 'completionDateStruct': {'date': '2007-01'}, 'lastUpdateSubmitDate': '2010-08-24', 'studyFirstSubmitDate': '2005-11-28', 'studyFirstSubmitQcDate': '2005-11-28', 'lastUpdatePostDateStruct': {'date': '2010-08-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-11-29', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Behavioral occurrence'}, {'measure': 'Care recipient depressive mood'}, {'measure': 'Caregiver upset'}], 'secondaryOutcomes': [{'measure': 'Activity engagement and vigilance'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Activity, Dementia, Caregiving'], 'conditions': ["Alzheimer's Disease"]}, 'referencesModule': {'references': [{'pmid': '19420314', 'type': 'DERIVED', 'citation': 'Gitlin LN, Winter L, Vause Earland T, Adel Herge E, Chernett NL, Piersol CV, Burke JP. The Tailored Activity Program to reduce behavioral symptoms in individuals with dementia: feasibility, acceptability, and replication potential. Gerontologist. 2009 Jun;49(3):428-39. doi: 10.1093/geront/gnp087. Epub 2009 May 6.'}]}, 'descriptionModule': {'briefSummary': 'Specific Aims\n\n1. Establish a preliminary effect size for the impact of the intervention on depressive affect and agitated behaviors in persons with dementia in 4 months\n2. Evaluate acceptance of and engagement in activities in persons with dementia\n3. Establish a preliminary effect size for the impact of the intervention on caregiver burden, depressive symptoms, and mastery at 4 months.\n4. Evaluate caregiver skills acquisition, acceptance of and compliance to intervention techniques.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Care Recipient\n* English Speaking\n* NINCDS-ADRDA diagnosis\\[physician generated of dementia or mini-mental state examination score of less than or equal to 23;3\\] Able to feel self; and participates in at least 2 other activities of daily living\\[ADLs-Bathing, Dressing, Grooming, Toileting, Transferring from bed to chair\\] As reported by caregiver.\n* Caregiver\n* English Speaking\n* Family member 21 years of age or older \\[male or female\\]\n* Lives with Care Recipient\n* Has telephone in the home\n* Plans to live in area for 8 months\n* Indicated willingness to learn new approaches by which to engage care recipient in meaningful activities\n* Provides 4 or more hours a day directly caring or providing for care recipient\n\nExclusion Criteria:\n\n* Care Recipient\n* Has Schizophrenia or Bi-Polar Disorder\n* Their Dementia is secondary to probable head trauma\n* Their MMSE score is equal to zero and they are bed bound, defined as confinement to bed or chair for at least 22 hours a day for at least 4 of 7 days\n* They are not responsive to their environment\n* Caregiver\n* Are currently involved in another clinical trial of psycho-social or educational interventions for caregivers\n* Are planning to place their family member in a nursing home within the next 8 months. Also, the care recipient/caregiver dyad will be excluded if either caregiver or care recipient: 1) has a terminal illness with life expectancy less than 8 months 2)is in active treatment for cancer or 3) has had greater than 3 acute medical hospitalizations within the past year.'}, 'identificationModule': {'nctId': 'NCT00259467', 'briefTitle': 'Project TAP: Tailored Activities Project', 'organization': {'class': 'OTHER', 'fullName': 'Thomas Jefferson University'}, 'officialTitle': 'Tailored Activity to Improve Affect in Dementia', 'orgStudyIdInfo': {'id': 'R21MH069425', 'link': 'https://reporter.nih.gov/quickSearch/R21MH069425', 'type': 'NIH'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Home-Based Behavorial Intervention', 'type': 'BEHAVIORAL'}]}, 'contactsLocationsModule': {'locations': [{'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson University', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Laura N Gitlin, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Thomas Jefferson University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Thomas Jefferson University', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Laura N. Gitlin, Ph.D', 'oldOrganization': 'Jefferson Center for Applied Research on Aging and Health'}}}}