Ignite Creation Date:
2025-12-25 @ 4:02 AM
Ignite Modification Date:
2025-12-26 @ 2:55 AM
Study NCT ID:
NCT05510102
Status:
UNKNOWN
Last Update Posted:
2022-08-24
First Post:
2022-08-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Characterization of Medical Student Burnout Using Remote Physiologic Monitoring
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000077062', 'term': 'Burnout, Psychological'}], 'ancestors': [{'id': 'D013315', 'term': 'Stress, Psychological'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR'], 'maskingDescription': 'Investigators are blinded to subject intervention group (data blinded versus data unblinded)'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Subjects will be randomized to a treatment group (full remote monitoring data) versus a control arm (blinded data).'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2022-08-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2023-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-08-23', 'studyFirstSubmitDate': '2022-08-18', 'studyFirstSubmitQcDate': '2022-08-18', 'lastUpdatePostDateStruct': {'date': '2022-08-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-08-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-02-22', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Total sleep hours per night', 'timeFrame': '180 days', 'description': 'Sleep (hours per night) will be objectively measured nightly.'}, {'measure': 'Medical Student Well-Being Index (MSWBI)', 'timeFrame': '180 days', 'description': 'The MSWBI consists of 7 items, scored 0-7, with lower scores indicative of better medical student wellbeing. This survey will be administered biweekly.'}], 'secondaryOutcomes': [{'measure': 'REM sleep hours, nightly', 'timeFrame': '180 days', 'description': 'REM sleep hours will be measured nightly by the WHOOP strap 4.0.'}, {'measure': 'Deep sleep hours, nightly', 'timeFrame': '180 days', 'description': 'Deep sleep hours will be measured nightly by the WHOOP strap 4.0.'}, {'measure': 'Resting heart rate, nightly', 'timeFrame': '180 days', 'description': 'Resting heart rate will be measured nightly by the WHOOP strap 4.0.'}, {'measure': 'Heart rate variability, nightly', 'timeFrame': '180 days', 'description': 'Heart rate variability will be measured nightly by the WHOOP strap 4.0.'}, {'measure': 'Respiration rate, nightly', 'timeFrame': '180 days', 'description': 'Respiration rate will be measured nightly by the WHOOP strap 4.0.'}, {'measure': 'Pulse oximetry, nightly', 'timeFrame': '180 days', 'description': 'Pulse oximetry will be measured nightly by the WHOOP strap 4.0.'}, {'measure': 'Body temperature, nightly', 'timeFrame': '180 days', 'description': 'Body temperature will be measured nightly by the WHOOP strap 4.0.'}, {'measure': 'Average duty hours per week', 'timeFrame': '180 days', 'description': 'Duty hours will be self-reported every week'}, {'measure': 'Perceived Stress Scale-4', 'timeFrame': '180 days', 'description': 'The PSS-4 consists of 4 items that assess perceived stress. The items are scored on a 4-point scale. This survey will be administered biweekly.'}, {'measure': 'Patient Health Questionnaire-9 (PHQ-9)', 'timeFrame': '180 days', 'description': 'The (Patient Health Questionnaire-9) PHQ-9 consists of 9 items that assess major depressive disorder. This survey will be administered biweekly. It is scored on a 0-27 scale with 27 representing most severe depression (worse outcomes).'}, {'measure': 'Scores on shelf examinations', 'timeFrame': '180 days', 'description': 'Subjects will self-report examination scores for shelf exams administered after each clinical rotation. Scores are reported on a 0-100 scale with 100 being the best score possible.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['WHOOP strap 4.0'], 'conditions': ['Wellness', 'Burnout', 'Remote Monitoring']}, 'descriptionModule': {'briefSummary': 'A reliable method for monitoring stress and burnout among medical students is critically needed. To address this gap, our team aims to utilize the cost-effective WHOOP strap 4.0 wearable device to continuously capture stress-relevant physiologic data (i.e., sleep hours, heart rate variability, respiration rate, resting heart rate) among up to 50 third-year medical students at 24 Sidney Kimmel Medical College at Thomas Jefferson University for 6 months.', 'detailedDescription': 'Aim 1: To determine whether physiologic metrics of sleep and heart rate variability correlate with subjective assessments of medical student wellness in a 6-month period.\n\nHypothesis: Less total sleep hours will correlate with higher scores for Perceived Stress Scale-4, Medical Student Well-Being Index, and Patient Health Questionnaire-9, but lower heart rate variability will correlate with higher scores on Perceived Stress Scale-4, Medical Student Well Being Index, and Patient Health Questionnaire-9.\n\nAim 2: To determine whether physiologic metrics of sleep and heart rate variability correlate with performance on shelf examinations for clinical rotations in a 6-month period.\n\nHypothesis: Less total sleep hours and lower heart rate variability will correlate with poorer performance on shelf examinations.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Third-year medical student at Thomas Jefferson University\n* ≥18 years of age\n* Actively participating in family medicine, internal medicine, neurology, obstetrics/gynecology, pediatrics, psychiatry, surgery, or emergency medicine rotations\n* Own a smart phone for Bluetooth pairing with WHOOP strap 4.0\n\nExclusion Criteria:\n\n* Allergies, contraindications, or unwillingness to wear a wrist device for the study period'}, 'identificationModule': {'nctId': 'NCT05510102', 'briefTitle': 'Characterization of Medical Student Burnout Using Remote Physiologic Monitoring', 'organization': {'class': 'OTHER', 'fullName': 'Thomas Jefferson University'}, 'officialTitle': 'Characterization of Medical Student Burnout Using Remote Physiologic Monitoring', 'orgStudyIdInfo': {'id': '21D.754'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment group', 'description': 'Subjects will have full remote monitoring data access throughout the entirety of the study (6 months).', 'interventionNames': ['Device: WHOOP strap 4.0 (full data access)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Subjects will be blinded to remote monitoring data for the first 3 months of the study followed by an unblinding and full access to remote monitoring data at the 3 month mark (continued for the remainder of the study).', 'interventionNames': ['Device: WHOOP strap 4.0 (partial data access)']}], 'interventions': [{'name': 'WHOOP strap 4.0 (full data access)', 'type': 'DEVICE', 'description': 'The WHOOP strap 4.0 provides continuous physiologic data via remote monitoring. Subjects will have full remote monitoring data access throughout the entirety of the study (6 months).', 'armGroupLabels': ['Treatment group']}, {'name': 'WHOOP strap 4.0 (partial data access)', 'type': 'DEVICE', 'description': 'The WHOOP strap 4.0 provides continuous physiologic data via remote monitoring. Subjects will be blinded to remote monitoring data for the first 3 months of the study followed by an unblinding and full access to remote monitoring data at the 3 month mark (continued for the remainder of the study).', 'armGroupLabels': ['Control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Sidney Kimmel Medical College at Thomas Jefferson University', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}], 'overallOfficials': [{'name': 'Alexander Hajduczok, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Thomas Jefferson University Hospital, Department of Cardiology'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Thomas Jefferson University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Alexander Hajduczok', 'investigatorAffiliation': 'Thomas Jefferson University'}}}}