Ignite Creation Date:
2025-12-24 @ 5:14 PM
Ignite Modification Date:
2025-12-28 @ 5:02 PM
Study NCT ID:
NCT05463250
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2022-07-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Smartwatch and Physician Well-Being
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002055', 'term': 'Burnout, Professional'}], 'ancestors': [{'id': 'D000073397', 'term': 'Occupational Stress'}, {'id': 'D009784', 'term': 'Occupational Diseases'}, {'id': 'D000077062', 'term': 'Burnout, Psychological'}, {'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': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 184}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-03', 'studyFirstSubmitDate': '2022-07-14', 'studyFirstSubmitQcDate': '2022-07-14', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Burnout', 'timeFrame': 'Up to 12 months', 'description': 'The Maslach Burnout Inventory measures emotional exhaustion, depersonalization, and low sense of personal accomplishment. Possible scores range from 0-27 (emotional exhaustion subscale), 0-10 (depersonalization subscale), and 0-40 (personal accomplishment subscale). Higher scores on the emotional exhaustion and depersonalization subscales and lower scores on the personal accomplishment subscale indicates worse outcome.'}], 'secondaryOutcomes': [{'measure': 'Physician Well-Being Index', 'timeFrame': 'Up to 12 months', 'description': 'The Physician Well-Being Index measures multiple dimensions of distress (burnout, fatigue, quality of life, stress) and satisfaction with work-life integration and meaning in work. The total score ranges from -2 to 9, with higher scores indicating a greater degree of distress, lower meaning in work, and less satisfaction with work-life integration.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Professional Burnout']}, 'referencesModule': {'references': [{'pmid': '40824640', 'type': 'DERIVED', 'citation': 'Dyrbye LN, West CP, Wilton AR, Satele DV, Athreya AP. Smartwatch Use and Physician Well-Being: A Randomized Clinical Trial. JAMA Netw Open. 2025 Aug 1;8(8):e2527275. doi: 10.1001/jamanetworkopen.2025.27275.'}]}, 'descriptionModule': {'briefSummary': "The prevalence of burnout and other forms of distress among physicians is alarmingly high. This clinical trial is being conducted to learn more about if wearing a Smartwatch and having access to its data improves physicians' sense of well-being and if data measured from Smartwatches contain a 'signal' that predicts well-being", 'detailedDescription': "We will conduct a randomized controlled trail to evaluate if wearing a Smartwatch improves overall well-being among physicians, and if so, in which dimension of well-being (e.g., fatigue, stress, overall quality of life, burnout). Additionally, we will explore if data from Smartwatches can predict subsequent well-being among physicians.\n\nStudy Aims:\n\n1. To determine if wearing a Smartwatch and having access to its physiological data (e.g., sleep, step count, activity, breathing reminders) improves well-being, and if so which well-being dimensions.\n2. To determine whether continuous physiological measures (measured from Smartwatches) contain a 'signal' that predicts physician well-being, and if so in which dimensions."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Physician\n\nExclusion Criteria:\n\n* non physicians'}, 'identificationModule': {'nctId': 'NCT05463250', 'briefTitle': 'Smartwatch and Physician Well-Being', 'organization': {'class': 'OTHER', 'fullName': 'University of Colorado, Denver'}, 'officialTitle': 'Smartwatch and Physician Well-being: Are Wearables Part of the Solution?', 'orgStudyIdInfo': {'id': '22-0799'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Smart Watch, then no intervention', 'description': 'Physicians will be asked to wear a Smartwatch for 6 months, and then will be monitored for the following 6 months without wearing a Smartwatch. Physicians will complete surveys about their experiences', 'interventionNames': ['Device: Smartwatch']}, {'type': 'EXPERIMENTAL', 'label': 'No intervention, then Smart Watch', 'description': 'Physicians will be monitored for the first 6 months without wearing a Smartwatch, and then will be asked to wear a Smartwatch for the following 6 months. Physicians will complete surveys about their experiences', 'interventionNames': ['Device: Smartwatch']}], 'interventions': [{'name': 'Smartwatch', 'type': 'DEVICE', 'description': 'Wearing a smartwatch and having access to its data', 'armGroupLabels': ['No intervention, then Smart Watch', 'Smart Watch, then no intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'country': 'United States', 'facility': 'Lotte Dyrbye', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}], 'overallOfficials': [{'name': 'Liselotte N Dyrbye, MD MHPE', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Colorado School of Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Colorado, Denver', 'class': 'OTHER'}, 'collaborators': [{'name': 'Physicians Foundation', 'class': 'UNKNOWN'}, {'name': 'Mayo Clinic', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}