Ignite Creation Date:
2025-12-25 @ 3:27 AM
Ignite Modification Date:
2026-02-25 @ 9:47 PM
Study NCT ID:
NCT03595605
Status:
COMPLETED
Last Update Posted:
2020-05-29
First Post:
2018-05-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Association Between Inpatient Steps Per Day and Patient Functional Status/Disposition
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016138', 'term': 'Walking'}, {'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D008124', 'term': 'Locomotion'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 51}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-05-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-05', 'completionDateStruct': {'date': '2019-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-05-28', 'studyFirstSubmitDate': '2018-05-22', 'studyFirstSubmitQcDate': '2018-07-12', 'lastUpdatePostDateStruct': {'date': '2020-05-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-07-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Determine how many steps patients admitted to the medicine units are taking at baseline', 'timeFrame': '1 Day', 'description': 'Steps will be measured using a wearable device (FitBit) designed to track number of steps for the duration of their hospital stay'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Physical Medicine']}, 'descriptionModule': {'briefSummary': "This study will incorporate the use of wearable actigraphy devices (Fitbit) on research participants admitted to medicine inpatient units at Tisch Hospital and/or NYU Brooklyn. The investigator's sample size will be 600 randomized into two groups, with basic inclusion criteria including age greater than 65 years and pre-hospital ambulatory status. While both groups will be monitored in terms of their activity (specifically pedometer data), the intervention group will have twice daily encouragement of ambulation. Once a subject is enrolled, data will be collected daily and at time of discharge."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '66 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Admitted to acute inpatient medicine unit\n* Ambulatory without assistive device prior to hospitalization\n* Medical clearance to ambulate on the unit\n* Active MyChart account or willing to activate MyChart account\n* iOS or Android device\n\nExclusion Criteria:\n\n* Patients less than or equal to 65 years old\n* Not Admitted to acute inpatient medicine unit\n* Ambulatory with assistive device prior to hospitalization\n* No Medical clearance to ambulate on the unit\n* Inactive MyChart account and not willing to activate MyChart account\n* No iOS or Android device\n\nIn addition, an individual who meets any of the following criteria will be excluded from participation in this study:\n\n* Oxygen requirement at rest\n* Lower extremity prosthesis\n* Admitted for joint replacement surgery\n* History of frequent falls\n* Admitted for syncope.\n* If patients have specifically opted out of being contacted about research (visible in the Epic header while in their chart)\n* Admitted from nursing home'}, 'identificationModule': {'nctId': 'NCT03595605', 'briefTitle': 'Association Between Inpatient Steps Per Day and Patient Functional Status/Disposition', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'Association Between Inpatient Steps Per Day and Patient Functional Status/Disposition', 'orgStudyIdInfo': {'id': '17-01792'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'FitBit Group', 'description': 'Will receive a wearable device (FitBit) designed to track number of steps for the duration of their hospital stay. They will receive nudges twice/day to ambulate', 'interventionNames': ['Behavioral: Ambulation']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control Group-Standard of Care', 'description': '300 subjects who will receive usual standard of care on a general inpatient medicine unit with the addition of a wearable device (FitBit) to track usual mobility in this setting. will complete their admission without push for increased activity (although having the device may influence their steps taken).', 'interventionNames': ['Other: Standard of Care']}], 'interventions': [{'name': 'Ambulation', 'type': 'BEHAVIORAL', 'description': 'This group will be encouraged twice daily to ambulate', 'armGroupLabels': ['FitBit Group']}, {'name': 'Standard of Care', 'type': 'OTHER', 'description': 'Care as usual at inpatient NYU Langone', 'armGroupLabels': ['Control Group-Standard of Care']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York University School of Medicine', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Gavriil Ilizarov', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYU Langone Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}