Ignite Creation Date:
2025-12-24 @ 9:54 PM
Ignite Modification Date:
2025-12-25 @ 7:32 PM
Study NCT ID:
NCT05537532
Status:
COMPLETED
Last Update Posted:
2022-09-13
First Post:
2022-09-09
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intern Health Study 2021
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D055991', 'term': 'Health Records, Personal'}], 'ancestors': [{'id': 'D008499', 'term': 'Medical Records'}, {'id': 'D011996', 'term': 'Records'}, {'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomization scheme'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1486}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-09', 'studyFirstSubmitDate': '2022-09-09', 'studyFirstSubmitQcDate': '2022-09-09', 'lastUpdatePostDateStruct': {'date': '2022-09-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-06-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Average daily step count', 'timeFrame': 'Daily, throughout intern year (1 year)', 'description': "Participants' daily step counts are recorded through a Fitbit or an apple watch. High step counts are considered a positive outcome as it indicates more physical activity.\n\nFor teams randomized into competition arm and randomized to compete on step count, their average daily step count is compared with the average step count of the opponent team."}], 'secondaryOutcomes': [{'measure': 'Average daily mood score', 'timeFrame': 'Daily, throughout intern year (1 year)', 'description': 'Through the study mobile app, participants enter a mood score (scale 1-10) every day of the study. 1 corresponds to lowest mood and 10 corresponds to highest mood.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Telemedicine']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the efficacy of gamified competition (delivered through a smartphone) for improving the physical activity and sleep of medical interns.', 'detailedDescription': "Due to their high-stress workloads, medical interns tend to have lower sleep and decreased physical activity. The goal of this study is to evaluate the efficacy of gamified competition (delivered through a smartphone) for improving the physical activity and sleep of medical interns. During the study, they are teamed up by programs and institutions and compete with other teams, which aim to motivate them to have more physical activity and sleep duration during their internship year.\n\nThe primary aim of this study is to investigate whether introducing competition mechanisms into mobile health (mHealth) interventions can improve a medical intern's activity-related behavioral outcomes: daily step counts and sleep duration. The first secondary aim is to assess the time-varying competition effect on their behavioral outcomes. The first exploratory aim is to assess the competition effect on study engagement and the second exploratory aim is to evaluate the competition effect on mental outcome, mood score."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Medical intern during the 2021-2022 internship year\n* Enrolled in study by the start of internship (7/1/22)\n\nExclusion Criteria:\n\n* None'}, 'identificationModule': {'nctId': 'NCT05537532', 'acronym': 'IHS 2021', 'briefTitle': 'Intern Health Study 2021', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Intern Health Study: 2021 Micro-Randomized Trial', 'orgStudyIdInfo': {'id': 'HUM00033029.21'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Competition group', 'description': 'Programs with at least five interns were grouped into program-based teams. Interns within the same residency institution in programs that did not meet this criterion were grouped into institution-based teams, with a minimum of five participants per team.\n\nFor each week, an eligible team is randomized to either a steps competition or non-competition group with 50/50 chance. For those randomized to competition arm, teams were assigned an opponent team by total randomization, by which the opponent team was assigned regardless of institution and specialty.', 'interventionNames': ['Behavioral: Intern Health Study competition-related mobile notification', 'Behavioral: Intern Health Study mobile app', 'Behavioral: Intern Health Study mobile app competition scoreboard and history']}, {'type': 'EXPERIMENTAL', 'label': 'Non-competition group', 'description': 'For each week, an eligible team is randomized to either competition or non-competition group with 50/50 chance.', 'interventionNames': ['Behavioral: Intern Health Study mobile app']}], 'interventions': [{'name': 'Intern Health Study competition-related mobile notification', 'type': 'BEHAVIORAL', 'description': 'Participants will receive three types of push notifications: 1. Alert of competition type (steps or sleep) and opponent (Sunday 9pm), 2. Competition score status update (Wednesday 9pm, Saturday 11am), and 3. Competition final results (Monday 12pm).', 'armGroupLabels': ['Competition group']}, {'name': 'Intern Health Study mobile app', 'type': 'BEHAVIORAL', 'description': 'The Intern Health Study mobile app is able to conduct a daily mood survey. It also aggregates and visualizes historical data on intern mood, activity, and sleep.', 'armGroupLabels': ['Competition group', 'Non-competition group']}, {'name': 'Intern Health Study mobile app competition scoreboard and history', 'type': 'BEHAVIORAL', 'description': 'Participant can view their current competition scoreboard and competition history at any time via the study app.', 'armGroupLabels': ['Competition group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}]}, 'ipdSharingStatementModule': {'url': 'https://www.openicpsr.org/openicpsr/project/129225/version/V1/view', 'infoTypes': ['ICF'], 'timeFrame': 'Data will be made available 12 months after the end of the trial. It will be made available indefinitely after that date.', 'ipdSharing': 'YES', 'description': 'De-identified genomic and survey information (baseline survey, plus quarterly survey which contains the PHQ-9) will be shared with the National Institute for Mental Health (NIMH).', 'accessCriteria': 'The data will be shared directly with the NIMH. NIMH will apply their criteria for qualified researchers and analyses.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Research Professor', 'investigatorFullName': 'Srijan Sen', 'investigatorAffiliation': 'University of Michigan'}}}}