Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2025-12-25 @ 11:21 PM
Study NCT ID:
NCT05411393
Status:
COMPLETED
Last Update Posted:
2025-07-20
First Post:
2022-06-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Synergizing Home Health Rehabilitation Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-12-05', 'releaseDate': '2025-11-24'}, {'releaseDate': '2025-12-11'}], 'estimatedResultsFirstSubmitDate': '2025-11-24'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D000073496', 'term': 'Frailty'}], 'ancestors': [{'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2024-01-30', 'size': 204001, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-07-16T15:25', 'hasProtocol': True}, {'date': '2024-01-30', 'size': 251758, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2025-01-24T12:21', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'The outcome assessor will be blinded to the group allocation of the patients.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Experimental arm versus the control arm'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 47}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-10-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-16', 'studyFirstSubmitDate': '2022-06-06', 'studyFirstSubmitQcDate': '2022-06-06', 'lastUpdatePostDateStruct': {'date': '2025-07-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-01-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Self-care items from the Outcome and Assessment Information Set', 'timeFrame': 'Two months', 'description': 'The self-care items evaluate the degree of independence in seven activities: eating, oral hygiene, toileting hygiene, upper body dressing, lower body dressing, shower/bathe, and putting on/removing footwear.'}], 'primaryOutcomes': [{'measure': 'The Assessment of Motor and Process Skills Assessment of Motor and Process Skills', 'timeFrame': 'Three months', 'description': 'A performance-based measure of activities of daily living.'}, {'measure': 'Activity Measure Post Acute Care: Home Care Short Form', 'timeFrame': 'six months', 'description': 'A patient-report outcome measure in mobility and self-care activities.'}], 'secondaryOutcomes': [{'measure': 'Box and Block Test', 'timeFrame': 'Three months', 'description': 'The test measures motor coordination of the upper extremity through moving small wooden blocks.'}, {'measure': 'Jebsen Hand Function Test', 'timeFrame': 'Three months', 'description': 'The test measures upper extremity function in seven tasks: sentence writing, card turning, moving small common objects (e.g., pennies), simulated feeding, stacking checkers, moving light objects, and moving heavy objects.'}, {'measure': 'Timed-Up-and-Go Test', 'timeFrame': 'Three months', 'description': 'The test measures functional mobility from getting up from a chair, walking, and returning to the chair.'}, {'measure': 'Short Physical Performance Battery', 'timeFrame': 'Three months', 'description': 'The test measures balance, walking speed and chair stand.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Rehabilitation'], 'conditions': ['Frailty', 'Frail Elderly', 'Occupational Therapy', 'Activities of Daily Living', 'Home Health Care', 'Functional Status', 'Physical Functional Performance', 'Rehabilitation', 'Treatment Outcome', 'Health Services for the Aged']}, 'descriptionModule': {'briefSummary': 'The objective of this project is to pilot test an ADL (activities of daily living)-enhanced program as an adjuvant therapy to usual home health rehabilitation to improve patient outcomes. The project will compare the ADL-enhanced program plus usual care with usual care using an RCT design in home health patients.', 'detailedDescription': "Regaining the ability to take care of oneself after an illness or medical episode is critical for home health patients to maintain independent living at home. An ADL-enhanced program may augment the effect of home health rehabilitation therapy to support patients' self-care outcomes. Patients will be randomly assigned to two groups: one will receive the ADL-enhanced program with usual home health care, and the other will receive usual home health care. Researchers will compare outcomes in self-care activities and physical performance between the two groups to determine the effect of the ADL-enhanced program."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Patients are eligible if they\n\n* are 65 years of age over older\n* are Medicare beneficiaries\n* are referred for skilled rehabilitation services at the partnered home health agency\n* have three or more comorbidities\n\nPatients are ineligible if they have\n\n* acute fractures with surgical or weight-bearing restrictions,\n* elective joint replacement surgery\n* lower-extremity amputation\n* active treatment for cancer diagnosis\n* ongoing dialysis treatment\n* acute cardiac surgery,\n* acute stroke or a major neurologic disorder limiting motor movements\n* terminal stage of congestive heart failure\n* a referral to hospice care\n* severe cognitive deficits limiting verbal communication.'}, 'identificationModule': {'nctId': 'NCT05411393', 'briefTitle': 'Synergizing Home Health Rehabilitation Therapy', 'organization': {'class': 'OTHER', 'fullName': 'University of Florida'}, 'officialTitle': "Synergizing Home Health Rehabilitation Therapy to Optimize Patients' Activities of Daily Living", 'orgStudyIdInfo': {'id': 'IRB202102816 -N'}, 'secondaryIdInfos': [{'id': 'R21AG076972', 'link': 'https://reporter.nih.gov/quickSearch/R21AG076972', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental arm', 'description': 'Research participants in this arm will receive the ADL-enhanced program and usual home health care rehabilitation. The ADL-enhanced program consists of six home visits delivered by a study occupational therapist.', 'interventionNames': ['Other: ADL-enhanced program', 'Other: Usual home health rehabilitation therapy']}, {'type': 'OTHER', 'label': 'Control arm', 'description': 'Research participants in this arm will receive usual home health care rehabilitation.', 'interventionNames': ['Other: Usual home health rehabilitation therapy']}], 'interventions': [{'name': 'ADL-enhanced program', 'type': 'OTHER', 'description': "The ADL-enhanced program consists of six home visits delivered by a study occupational therapy staff. The study therapy staff will use the compensatory approach and the restorative approach during the visits to enhance patients' activity engagement. The compensatory approach uses strategies to reduce the activity demand to make every task easier. For example, using the sitting position to perform self-care tasks. The restorative approach uses strategies to increase the demand of the task to increase the patient's functional capacity. For example, carrying a full-load laundry basket versus an empty laundry basket.", 'armGroupLabels': ['Experimental arm']}, {'name': 'Usual home health rehabilitation therapy', 'type': 'OTHER', 'description': 'Usual home health rehabilitation therapy is prescribed by the home health agency. It often includes occupational therapy and physical therapy delivered in one to three home visits per week for one to two months.', 'armGroupLabels': ['Control arm', 'Experimental arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32610', 'city': 'Gainesville', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Florida', 'geoPoint': {'lat': 29.65163, 'lon': -82.32483}}], 'overallOfficials': [{'name': 'Chiung-ju Liu, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Florida'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Florida', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute on Aging (NIA)', 'class': 'NIH'}], 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-11-24', 'type': 'RELEASE'}, {'date': '2025-12-05', 'type': 'RESET'}], 'unpostedResponsibleParty': 'University of Florida'}}}}