Ignite Creation Date:
2025-12-24 @ 1:27 PM
Ignite Modification Date:
2026-01-07 @ 7:07 AM
Study NCT ID:
NCT01743495
Status:
COMPLETED
Last Update Posted:
2020-02-12
First Post:
2012-10-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CAPABLE for Frail Dually Eligible Older Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018908', 'term': 'Muscle Weakness'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 281}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2019-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-10', 'studyFirstSubmitDate': '2012-10-15', 'studyFirstSubmitQcDate': '2012-12-04', 'lastUpdatePostDateStruct': {'date': '2020-02-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-12-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cost Effective', 'timeFrame': 'one year after intervention', 'description': 'Chart review to see change between cost of intervention to medicaid before and after CAPABALE'}, {'measure': 'Cost Effective', 'timeFrame': 'two years after intervention', 'description': 'Chart review to see change between cost of intervention to medicaid before and after CAPABALE'}, {'measure': 'Cost Effective', 'timeFrame': 'one year after intervention', 'description': 'Chart review to see change between cost of intervention to medicare before and after CAPABALE'}, {'measure': 'Cost Effective', 'timeFrame': 'two years after intervention', 'description': 'Chart review to see change between cost of intervention to medicare before and after CAPABALE'}], 'secondaryOutcomes': [{'measure': 'Quality of Life as assessed by the Activities of Daily Living (ADL) Questionnaire', 'timeFrame': 'four months post intervention', 'description': 'The ADL Questionnaire will be used to assess quality of life in participants. The score ranges from 0 to 32, with 0 being no help required with activities of daily life and 32 representing that the participant is incapable of completing activities of daily life regardless of difficulty without assistance.'}, {'measure': 'Quality of Life as assessed by the ADL Questionnaire', 'timeFrame': 'eight months post intervention', 'description': 'The ADL Questionnaire will be used to assess quality of life in participants. The score ranges from 0 to 32, with 0 being no help required with activities of daily life and 32 representing that the participant is incapable of completing activities of daily life regardless of difficulty without assistance.'}, {'measure': 'Quality of Life as assessed by the ADL Questionnaire', 'timeFrame': 'twelve months post intervention', 'description': 'The ADL Questionnaire will be used to assess quality of life in participants. The score ranges from 0 to 32, with 0 being no help required with activities of daily life and 32 representing that the participant is incapable of completing activities of daily life regardless of difficulty without assistance.'}, {'measure': 'Quality of Life as assessed by the Instrumental Activities of Daily Living (IADL) Questionnaire', 'timeFrame': 'four months post intervention', 'description': 'The IADL Questionnaire will be used to assess quality of life in participants. The score ranges from 0 to 32, with 0 being no help required with activities of daily life and 32 representing that the participant is incapable of completing instrumental activities of daily life regardless of difficulty without assistance.'}, {'measure': 'Quality of Life as assessed by the IADL Questionnaire', 'timeFrame': 'eight months post intervention', 'description': 'The IADL Questionnaire will be used to assess quality of life in participants. The score ranges from 0 to 32, with 0 being no help required with activities of daily life and 32 representing that the participant is incapable of completing instrumental activities of daily life regardless of difficulty without assistance.'}, {'measure': 'Quality of Life as assessed by the IADL Questionnaire', 'timeFrame': 'twelve months post intervention', 'description': 'The IADL Questionnaire will be used to assess quality of life in participants. The score ranges from 0 to 32, with 0 being no help required with activities of daily life and 32 representing that the participant is incapable of completing instrumental activities of daily life regardless of difficulty without assistance.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Medical Costs', 'improved IADLs', "and/or ADL's", 'decreased nursing home admissions'], 'conditions': ['Muscle Weakness']}, 'referencesModule': {'references': [{'pmid': '29165789', 'type': 'DERIVED', 'citation': 'Szanton SL, Alfonso YN, Leff B, Guralnik J, Wolff JL, Stockwell I, Gitlin LN, Bishai D. Medicaid Cost Savings of a Preventive Home Visit Program for Disabled Older Adults. J Am Geriatr Soc. 2018 Mar;66(3):614-620. doi: 10.1111/jgs.15143. Epub 2017 Nov 22.'}, {'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 Johns Hopkins School of Nursing offers this research study which aims to learn more about whether services that help with medications, muscle strengthening, pain management and changes to houses can help improve older adults' ability to, walk, and take care of themselves while saving costs by reducing hospitalizations and nursing home admissions.", 'detailedDescription': '* 65yrs or older\n* Be able to stand (with or without assistance)\n* Have some difficulty with getting dressed, or preparing food, bathing\n* Receive a low monthly income\n* Have no plans to move in the next year\n* NOT be receiving home nursing or other therapy right now'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 65 or older\n* Cognitively intact (≥ 10 on Brief Interview of Mental Status)\n* Difficulty with ≥ 2 IADLS or ≥ 1 ADL\n* ≤ 199% of Federal Poverty level\n\nExclusion Criteria:\n\n* Terminally ill\n\n --Active cancer treatment\n* Hospitalized \\> 3 times in last 3 years\n* Receiving home nursing, Occupational Therapy or Physical Therapy\n* Don't have phone or do plan to move in less than a year"}, 'identificationModule': {'nctId': 'NCT01743495', 'acronym': 'CAPABLE500', 'briefTitle': 'CAPABLE for Frail Dually Eligible Older Adults', 'organization': {'class': 'OTHER', 'fullName': 'Johns Hopkins University'}, 'officialTitle': 'CAPABLE for Frail Dually Eligible Older Adults', 'orgStudyIdInfo': {'id': 'NA_00076471'}, 'secondaryIdInfos': [{'id': '1C1CMS330970-01-00', 'type': 'OTHER', 'domain': 'Centers for Medicare and Medicaid Services'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Functional Services', 'description': 'The program consists of up to 10 home-based functional services sessions over 4 months.', 'interventionNames': ['Behavioral: 10 home-based functional services sessions over 4 months.']}], 'interventions': [{'name': '10 home-based functional services sessions over 4 months.', 'type': 'BEHAVIORAL', 'description': 'The program consists of up to 10 home-based functional services sessions over 4 months.', 'armGroupLabels': ['Functional Services']}]}, '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', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Johns Hopkins University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johns Hopkins University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centers for Medicare and Medicaid Services', 'class': 'FED'}, {'name': 'Baltimore City Health Department', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}