Ignite Creation Date:
2025-12-25 @ 2:52 AM
Ignite Modification Date:
2025-12-30 @ 4:38 PM
Study NCT ID:
NCT01576133
Status:
COMPLETED
Last Update Posted:
2018-07-02
First Post:
2012-04-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reducing Disability Via a Bundled Bio-Behavioral-Environmental Approach
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C113562', 'term': 'CAPABLE protocol'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'Outcomes assessor did not know which study group the person they visited was in and told participant not to reveal it.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Time limited home based intervention of a Nurse, Occupational Therapist, and a "handyman" to work with low income older adults to assess, prioritize and meet their functional goals.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 300}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-06', 'completionDateStruct': {'date': '2017-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-06-28', 'studyFirstSubmitDate': '2012-04-04', 'studyFirstSubmitQcDate': '2012-04-10', 'lastUpdatePostDateStruct': {'date': '2018-07-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-04-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Activities of Daily Living (ADLs)', 'timeFrame': '5 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Quality of Life'], 'conditions': ['Quality of Life']}, 'referencesModule': {'references': [{'pmid': '30615024', 'type': 'DERIVED', 'citation': 'Szanton SL, Xue QL, Leff B, Guralnik J, Wolff JL, Tanner EK, Boyd C, Thorpe RJ Jr, Bishai D, Gitlin LN. Effect of a Biobehavioral Environmental Approach on Disability Among Low-Income Older Adults: A Randomized Clinical Trial. JAMA Intern Med. 2019 Feb 1;179(2):204-211. doi: 10.1001/jamainternmed.2018.6026.'}, {'pmid': '28007445', 'type': 'DERIVED', 'citation': 'Waldersen BW, Wolff JL, Roberts L, Bridges AE, Gitlin LN, Szanton SL. Functional Goals and Predictors of Their Attainment in Low-Income Community-Dwelling Older Adults. Arch Phys Med Rehabil. 2017 May;98(5):896-903. doi: 10.1016/j.apmr.2016.11.017. Epub 2016 Dec 19.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine whether a combination of occupational therapy visits, nursing visits, and handyman repair are effective in helping low income older adults avoid costly health care services', 'detailedDescription': "We will recruit low-income age 65 or older\n\n-principally African-American, adults from the Baltimore Department of Housing Energy Assistance Program.\n\n-We will interview them at home and randomize participants to either the treatment (CAPABLE intervention) or control (attention-control) group. Participants in the treatment group will receive up to 10 in-home sessions -- 6 visits with an occupational therapist and 4 visits from a nurse - and $1200 in safety and modification services from a licensed handyman. Each treatment participant will receive each intervention component but interventionists will systematically tailor content to the participants' risk profile and goals based on protocols."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* at least 65 years old\n* cognitively intact\n* difficulty with at least one activity of daily living or two instrumental activities of daily living\n* less than 175% of the Federal Poverty level\n* be able to stand with or without assistance\n* agree to study participation\n\nExclusion Criteria:\n\n* hospitalized more than three times in the last year\n* receiving in home rehabilitation\n* have a terminal diagnosis with less than one year life expectancy\n* plan to move in less than one year'}, 'identificationModule': {'nctId': 'NCT01576133', 'acronym': 'CAPABLE', 'briefTitle': 'Reducing Disability Via a Bundled Bio-Behavioral-Environmental Approach', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'Reducing Disability Via a Bundled Bio-Behavioral-Environmental Approach', 'orgStudyIdInfo': {'id': 'NA_00031539'}, 'secondaryIdInfos': [{'id': 'R01AG040100', 'link': 'https://reporter.nih.gov/quickSearch/R01AG040100', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CAPABLE', 'description': 'Experimental group participants received up to 10 sessions; up to 6 with an OT, and up to 4 sessions with an RN, and ≤ $1200 of safety and functional modifications from a licensed handyman. These sessions happened in coordinated fashion over the course of 4 months.', 'interventionNames': ['Behavioral: CAPABLE']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Attention visits', 'description': 'Participants in the attention visit arm received 10 visits of one hour length spaced across 16 weeks. These visits included sedentary activities of their choice based on their goals and interests.', 'interventionNames': ['Behavioral: Attention visits']}], 'interventions': [{'name': 'CAPABLE', 'type': 'BEHAVIORAL', 'description': 'Occupational therapy visits plus nursing visits plus handyman repair', 'armGroupLabels': ['CAPABLE']}, {'name': 'Attention visits', 'type': 'BEHAVIORAL', 'description': 'Participants in the attention control arm will receive 10 one hour visits over the course of 16 weeks. These visits will consist of sedentary activities', 'armGroupLabels': ['Attention visits']}]}, 'contactsLocationsModule': {'locations': [{'zip': '21205', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University School of Nursing', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}], 'overallOfficials': [{'name': 'Sarah Szanton, PhD, ANP', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University School of Nursing'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}}