Ignite Creation Date:
2025-12-26 @ 1:19 PM
Ignite Modification Date:
2025-12-29 @ 3:56 PM
Study NCT ID:
NCT00901706
Status:
COMPLETED
Last Update Posted:
2013-06-18
First Post:
2009-05-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Multidimensional Assessment and Intervention for Elder Self-Neglect
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015577', 'term': 'Geriatric Assessment'}, {'id': 'D016032', 'term': 'Randomized Controlled Trials as Topic'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D006304', 'term': 'Health Status'}, {'id': 'D003710', 'term': 'Demography'}, {'id': 'D011154', 'term': 'Population Characteristics'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D015991', 'term': 'Epidemiologic Measurements'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}, {'id': 'D018849', 'term': 'Controlled Clinical Trials as Topic'}, {'id': 'D002986', 'term': 'Clinical Trials as Topic'}, {'id': 'D000068456', 'term': 'Clinical Studies as Topic'}, {'id': 'D016020', 'term': 'Epidemiologic Study Characteristics'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2012-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-17', 'studyFirstSubmitDate': '2009-05-12', 'studyFirstSubmitQcDate': '2009-05-13', 'lastUpdatePostDateStruct': {'date': '2013-06-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-05-14', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Self-Neglect Severity Scale (SSS)', 'timeFrame': 'Baseline and 6-months'}], 'secondaryOutcomes': [{'measure': 'Functional Status', 'timeFrame': 'Baseline and 6-months'}, {'measure': 'Kohlman Evaluation of Living Skills (KELS)', 'timeFrame': 'Baseline and 6-months'}, {'measure': 'Mini-mental State Exam (MMSE)', 'timeFrame': 'Baseline and 6-months'}, {'measure': '15-item Geriatric Depression Scale', 'timeFrame': 'Baseline and 6-months'}, {'measure': 'Physical Performance Test (PPT)', 'timeFrame': 'Baseline and 6-months'}, {'measure': 'SF-36 Health Survey', 'timeFrame': 'Baseline and 6-months'}, {'measure': 'The Duke Social Support Index (DSSI)', 'timeFrame': 'Baseline and 6-months'}, {'measure': 'Client Satisfaction Questionnaire (CSQ-8)', 'timeFrame': 'Baseline and 6-months'}, {'measure': 'Costs of Social Services and Health Care Utilization and Costs', 'timeFrame': 'Months 1,2,3,4,5,6'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Self-Neglect', 'Comprehensive Geriatric Assessment (CGA)', 'Geriatric Syndromes', 'Quality of Life', 'Basic Activities of Daily Living', 'Instrumental Activities of Daily Living'], 'conditions': ['Self-Neglect', 'Cognitive Ability, General', 'Geriatric Disorder']}, 'descriptionModule': {'briefSummary': 'This study is designed to assess the best method for caring for elders reported to Adult Protective Services (APS) for self-neglect. Specifically, this study will compare APS usual care coupled with interdisciplinary comprehensive geriatric care to APS usual care alone in improving the health and quality of live among elders with substantiated self-neglect.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 65 years of age or older\n* English Speaking\n* Resident of Harris County, Houston Texas\n* Community-dwelling\n* Substantiated Self-Neglect\n\nExclusion Criteria:\n\n* No other substantiated allegations\n* Non-community dweller\n* No available for projected follow-up period\n* Impaired decision-making with no available proxy\n* Already receiving care from TEAM or within the past year\n* Terminal Illness'}, 'identificationModule': {'nctId': 'NCT00901706', 'briefTitle': 'Multidimensional Assessment and Intervention for Elder Self-Neglect', 'organization': {'class': 'OTHER', 'fullName': 'The University of Texas Health Science Center, Houston'}, 'officialTitle': 'Multidimensional Assessment and Intervention for Elder Self-Neglect', 'orgStudyIdInfo': {'id': 'HSC-MS-08-0052'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CGA plus APS Usual Care', 'description': 'Comprehensive geriatric assessment coupled with Adult Protective Services (APS) usual care for elders with self-neglect.', 'interventionNames': ['Other: Comprehensive Geriatric Assessment and APS Usual Care', 'Other: APS usual care']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'APS Usual Care', 'description': 'APS usual care consisting of social, medical, and legal interventions.', 'interventionNames': ['Other: Comprehensive Geriatric Assessment and APS Usual Care', 'Other: APS usual care']}], 'interventions': [{'name': 'Comprehensive Geriatric Assessment and APS Usual Care', 'type': 'OTHER', 'otherNames': ['Randomized Controlled Trial'], 'description': 'Comprehensive Geriatric Assessment coupled with APS usual care which collectively will consist standardized cognitive, functional, affective, social, and legal interventions.', 'armGroupLabels': ['APS Usual Care', 'CGA plus APS Usual Care']}, {'name': 'APS usual care', 'type': 'OTHER', 'otherNames': ['Randomized Controlled Trial'], 'description': 'APS usual care consists of social, medical, and legal assistance.', 'armGroupLabels': ['APS Usual Care', 'CGA plus APS Usual Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'The University of Texas Health Science Center at Houston', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'overallOfficials': [{'name': 'Carmel B. Dyer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'The University of Texas Health Science Center, Houston'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The University of Texas Health Science Center, Houston', 'class': 'OTHER'}, 'collaborators': [{'name': 'The Center for Clinical and Translational Sciences (CCTS) Clinical Research Unit at The University of Texas Health Science Center at Houston', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor, Internal Medicine, Geriatrics', 'investigatorFullName': 'Carmel Dyer', 'investigatorAffiliation': 'The University of Texas Health Science Center, Houston'}}}}