Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2025-12-26 @ 4:05 AM
Study NCT ID:
NCT03277118
Status:
COMPLETED
Last Update Posted:
2019-10-03
First Post:
2017-05-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Quantifying Activity Using Wireless Wearable Technology
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D003693', 'term': 'Delirium'}], 'ancestors': [{'id': 'D001519', 'term': 'Behavior'}, {'id': 'D003221', 'term': 'Confusion'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 91}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2019-08-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-02', 'studyFirstSubmitDate': '2017-05-17', 'studyFirstSubmitQcDate': '2017-09-07', 'lastUpdatePostDateStruct': {'date': '2019-10-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-09-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of steps walked', 'timeFrame': 'Postoperative day 2 to Postoperative day 5', 'description': 'Number of steps walked as measured by the Wireless Wearable Device'}], 'secondaryOutcomes': [{'measure': 'Length of sleep', 'timeFrame': 'Postoperative Day 1', 'description': 'Number of hours slept with little activity as measured by the Wireless Wearable Device'}, {'measure': 'Delirium', 'timeFrame': 'Postoperative Day 2 (after extubation)', 'description': 'Occurrence of delirium with few hours slept as measured by the Wireless Wearable Device'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Activity, Motor', 'Sleep', 'Delirium']}, 'descriptionModule': {'briefSummary': 'Wireless wearable devices (WWD) have been shown to be an effective means to measure patient activity and sleep-wake cycles in the ICU. However, no current studies involving WWD have demonstrated the ability of these devices to measure adverse outcomes, including delirium in critically ill patients. This study is unique because the investigators will implement monitoring with the WWD prior to extubation in the ICU to correctly measure first mobilization, as well as capture quality of sleep and episodes of delirium for the first five postoperative days.', 'detailedDescription': 'In this single-center non-randomized prospective cohort study, cardiac surgical patients undergoing cardiac surgery with cardiopulmonary bypass will be enrolled consecutively with written informed consent from the time this protocol is approved by the IRB until 100 subjects are enrolled (expected duration of subject enrollment is 12 months). Upon arrival into the ICU, cardiac surgery subjects will have a Fitbit Charge 2 device placed on their wrist and will wear the device until the fifth post-operative day. This device will wirelessly transmit data regarding activity and sleep quality to a smartphone application for the duration of wear. No identifiable patient information will be entered into the smartphone application or transmitted to any external entity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients aged 18 years or older who are scheduled to undergo elective cardiac surgery at UT Southwestern Medical Center.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inclusion Criteria: Adult (Age \\> 18) patients undergoing scheduled, elective cardiac surgery with cardiopulmonary bypass\n\nExclusion Criteria:\n\n* Those who do not meet the inclusion criteria, pregnant women, prisoners, those with skin or systemic infections, those who are paraplegic or quadriplegic and those with allergies to the polyurethane material comprising the FitBit strap.'}, 'identificationModule': {'nctId': 'NCT03277118', 'briefTitle': 'Quantifying Activity Using Wireless Wearable Technology', 'organization': {'class': 'OTHER', 'fullName': 'University of Texas Southwestern Medical Center'}, 'officialTitle': 'Quantifying Activity After Cardiac Surgery Using Wireless Wearable Technology', 'orgStudyIdInfo': {'id': 'STU 032017-102'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Cardiac Surgery Cohort', 'description': 'Patients aged 18 years or older who are scheduled to undergo elective cardiac surgery with cardiopulmonary bypass.', 'interventionNames': ['Device: Wireless Wearable Device']}], 'interventions': [{'name': 'Wireless Wearable Device', 'type': 'DEVICE', 'description': 'Wireless Wearable Device will be placed on the wrist of the patient prior to extubation in the ICU to record patient activity in terms of steps and sleep quality.', 'armGroupLabels': ['Cardiac Surgery Cohort']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'UT Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}], 'overallOfficials': [{'name': 'Sreekanth Cheruku, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas Southwestern Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Texas Southwestern Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Sreekanth Cheruku', 'investigatorAffiliation': 'University of Texas Southwestern Medical Center'}}}}