Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2025-12-26 @ 3:04 AM
Study NCT ID:
NCT03489720
Status:
COMPLETED
Last Update Posted:
2020-04-14
First Post:
2018-03-29
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Evaluation of a Daily Brief Exercise Intervention on Resident Physician Personal Resiliency and Burnout
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002055', 'term': 'Burnout, Professional'}, {'id': 'D000077062', 'term': 'Burnout, Psychological'}], 'ancestors': [{'id': 'D000073397', 'term': 'Occupational Stress'}, {'id': 'D009784', 'term': 'Occupational Diseases'}, {'id': 'D013315', 'term': 'Stress, Psychological'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'uma.shastri@vumc.org', 'phone': '615-936-3198', 'title': 'Dr. Uma Shastri', 'organization': 'Vanderbilt University Medical Center'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '16 weeks of study participation', 'eventGroups': [{'id': 'EG000', 'title': 'Exercise Intervention', 'description': 'Prescribed Exercise Program: Brief cardiovascular exercise training (\\>70% of maximum heart rate) for 15 minutes a day, 5 days a week for 8 weeks.\n\nThe exercise intervention will be a 15-minute per day of vigorous exercise that as monitored by a Fitbit Charge 2.\n\nExamples of possible 15-minute exercise regimens to be used include:\n\n* Walking quickly or running up and down stairs\n* Plyometric exercises such as jumping jacks, high knees, squats, lunges, speed skaters, froggers, etc\n* Walking up an incline on a treadmill\n* Jogging or running on a treadmill or elliptical\n* Stationary cycling or rowing', 'otherNumAtRisk': 46, 'deathsNumAtRisk': 46, 'otherNumAffected': 0, 'seriousNumAtRisk': 46, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Usual Exercise Program', 'description': 'Usual Exercise Program: Usual exercise activity for 8 weeks', 'otherNumAtRisk': 44, 'deathsNumAtRisk': 44, 'otherNumAffected': 0, 'seriousNumAtRisk': 44, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'The Change in the Emotional Exhaustion (EE) Burnout Score(as Measured by the Maslach Burnout Inventory (MBI)From Baseline to End of Each Exercise Phase.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exercise Intervention', 'description': 'Prescribed Exercise Program: Brief cardiovascular exercise training (\\>70% of maximum heart rate) for 15 minutes a day, 5 days a week for 8 weeks.\n\nThe exercise intervention will be a 15-minute per day of vigorous exercise that as monitored by a Fitbit Charge 2.\n\nExamples of possible 15-minute exercise regimens to be used include:\n\n* Walking quickly or running up and down stairs\n* Plyometric exercises such as jumping jacks, high knees, squats, lunges, speed skaters, froggers, etc\n* Walking up an incline on a treadmill\n* Jogging or running on a treadmill or elliptical\n* Stationary cycling or rowing\n\nUsual Exercise Program: Usual exercise activity for 8 weeks'}, {'id': 'OG001', 'title': 'Usual Exercise Program', 'description': 'Usual Exercise Program: Usual exercise activity for 8 weeks'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20.95348837', 'spread': '9.756447168', 'groupId': 'OG000'}, {'value': '20.93023256', 'spread': '10.40694674', 'groupId': 'OG001'}]}]}, {'title': 'Change after 8 weeks of exercise phase', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '42', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.976190476', 'spread': '7.416159335', 'groupId': 'OG000'}, {'value': '-0.095238095', 'spread': '6.472491599', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 8 weeks', 'description': 'The change in the Emotional Exhaustion (EE) burnout score(as measured by the Maslach Burnout Inventory (MBI)from baseline to end of each exercise phase.\n\nMBI-HSS is a survey to measure burnout in professionals in human services. MBI-HSS EE score includes 9 items to evaluate emotional exhaustion (EE), with scores ranging from 0 to 6 on the Likert scale. MBI-HSS EE total score ranges from 0 to 54 points. We consider a high degree of burnout in the case of EE ≥ 27 points. Moderate burnout will be considered in the case of 26\\<EE\\<19 points. Low levels will be considered for EE≤18 points.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was not available for analysis of baseline data for 1 participant in each exercise phase.\n\nData was not available for analysis of change in MBI-EE for 2 participants in each exercise phase.'}, {'type': 'PRIMARY', 'title': 'The Change in the Depersonalization (DP) Burnout Score(as Measured by the Maslach Burnout Inventory (MBI))From Baseline to End of Each Exercise Phase.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exercise Intervention', 'description': 'Prescribed Exercise Program: Brief cardiovascular exercise training (\\>70% of maximum heart rate) for 15 minutes a day, 5 days a week for 8 weeks.\n\nThe exercise intervention will be a 15-minute per day of vigorous exercise that as monitored by a Fitbit Charge 2.\n\nExamples of possible 15-minute exercise regimens to be used include:\n\n* Walking quickly or running up and down stairs\n* Plyometric exercises such as jumping jacks, high knees, squats, lunges, speed skaters, froggers, etc\n* Walking up an incline on a treadmill\n* Jogging or running on a treadmill or elliptical\n* Stationary cycling or rowing'}, {'id': 'OG001', 'title': 'Usual Exercise Program', 'description': 'Usual Exercise Program: Usual exercise activity for 8 weeks'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '8.465116279', 'spread': '4.762696501', 'groupId': 'OG000'}, {'value': '8.181818182', 'spread': '5.077413402', 'groupId': 'OG001'}]}]}, {'title': 'Change after 8 weeks of usual exercise program', 'denoms': [{'units': 'Participants', 'counts': [{'value': '42', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.139534884', 'spread': '3.412731034', 'groupId': 'OG000'}, {'value': '-0.727272727', 'spread': '3.743916842', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 8 weeks', 'description': 'The change in the Depersonalization (DP) burnout score(as measured by the Maslach Burnout Inventory (MBI))from baseline to end of each exercise phase.\n\nMBI-HSS is a survey to measure burnout in professionals in human services. MBI-HSS DP score includes 5 items to evaluate depersonalization (DP) with scores ranging from 0 to 6 on the Likert scale. MBI-HSS DP total score ranges from 0 to 30 points. We consider a high degree of burnout in the case of DP≥ 13 points. Moderate burnout will be considered in the case of 7-12 DP points. 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MBI-HSS PA score includes 8 items to evaluate Personal Accomplishment (PA) with scores ranging from 0 to 6 on the Likert scale. MBI-HSS PA total score ranges from 0 to 48 points. We consider a high degree of burnout in the case of PA≥ 39 points. Moderate burnout will be considered in the case of 32-38 PA points. Low levels will be considered for PA ≤31 points.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Data was available for analysis of change for 43 (exercise intervention) and 42 (usual exercise)'}, {'type': 'PRIMARY', 'title': 'Change in the Emotional Exhaustion (EE) Burnout Score(as Measured by MBI From Baseline to End of Each Exercise Phase Stratified by Training Level (Post Graduate Year 1 (PGY1), Post Graduate Year 2 (PGY2), and Post Graduate Year 3 (PGY3))', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exercise Intervention', 'description': 'Prescribed Exercise Program: Brief cardiovascular exercise training (\\>70% of maximum heart rate) for 15 minutes a day, 5 days a week for 8 weeks.\n\nThe exercise intervention will be a 15-minute per day of vigorous exercise that as monitored by a Fitbit Charge 2.\n\nExamples of possible 15-minute exercise regimens to be used include:\n\n* Walking quickly or running up and down stairs\n* Plyometric exercises such as jumping jacks, high knees, squats, lunges, speed skaters, froggers, etc\n* Walking up an incline on a treadmill\n* Jogging or running on a treadmill or elliptical\n* Stationary cycling or rowing'}, {'id': 'OG001', 'title': 'Usual Exercise Program', 'description': 'Usual Exercise Program: Usual exercise activity for 8 weeks'}], 'classes': [{'title': 'Post graduate year 1: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21.2', 'spread': '10.37992568', 'groupId': 'OG000'}, {'value': '20.125', 'spread': '11.43022309', 'groupId': 'OG001'}]}]}, {'title': 'Post graduate year 1: Change after 8 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.266666667', 'spread': '5.66274374', 'groupId': 'OG000'}, {'value': '-2.0625', 'spread': '6.287222492', 'groupId': 'OG001'}]}]}, {'title': 'Post graduate year 2: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20.84615385', 'spread': '9.948585778', 'groupId': 'OG000'}, {'value': '20.84615385', 'spread': '10.07344822', 'groupId': 'OG001'}]}]}, {'title': 'Post graduate year 2: Change after 8 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1.846153846', 'spread': '8.434513954', 'groupId': 'OG000'}, {'value': '0.833333333', 'spread': '5.89067059', 'groupId': 'OG001'}]}]}, {'title': 'Post graduate year 3: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '20.8', 'spread': '9.637723501', 'groupId': 'OG000'}, {'value': '21.92857143', 'spread': '10.17889435', 'groupId': 'OG001'}]}]}, {'title': 'Post graduate year 3: Change after 8 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-2.214285714', 'spread': '7.856193749', 'groupId': 'OG000'}, {'value': '2.071428571', 'spread': '6.521730371', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 8 weeks', 'description': 'The change in the Emotional Exhaustion burnout score(as measured by the Maslach Burnout Inventory (MBI)from baseline to end of each exercise phase stratified by training level.\n\nMBI-HSS is a survey to measure burnout in professionals in human services. MBI-HSS includes 9 items to evaluate emotional exhaustion (EE) with scores ranging from 0 to 6 on the Likert scale. MBI-HSS EE total score ranges from 0 to 54 points. We consider a high degree of burnout in the case of EE ≥ 27 points. Moderate burnout will be considered in the case of 26\\<EE\\<19 points. Low levels will be considered for EE≤18 points.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': '16 PGY1, 13 PGY2, \\&15 PGY3 participated in study. Data not available in 1 PGY1 participant in exercise intervention period. Data not available to assess change after usual exercise period for 1 PGY2 participant. Data not available for 1 PGY3 participnt for baseline or change in usual exercise period, \\& change in 1 participant exercise intervention.'}, {'type': 'PRIMARY', 'title': 'The Change in the Depersonalization (DP) Burnout Score(as Measured by the Maslach Burnout Inventory (MBI))From Baseline to End of Each Exercise Phase Stratified by Training Level.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '44', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exercise Intervention', 'description': 'Prescribed Exercise Program: Brief cardiovascular exercise training (\\>70% of maximum heart rate) for 15 minutes a day, 5 days a week for 8 weeks.\n\nThe exercise intervention will be a 15-minute per day of vigorous exercise that as monitored by a Fitbit Charge 2.\n\nExamples of possible 15-minute exercise regimens to be used include:\n\n* Walking quickly or running up and down stairs\n* Plyometric exercises such as jumping jacks, high knees, squats, lunges, speed skaters, froggers, etc\n* Walking up an incline on a treadmill\n* Jogging or running on a treadmill or elliptical\n* Stationary cycling or rowing'}, {'id': 'OG001', 'title': 'Usual Exercise Program', 'description': 'Usual Exercise Program: Usual exercise activity for 8 weeks'}], 'classes': [{'title': 'Post graduate year 1: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '6.866666667', 'spread': '4.596064569', 'groupId': 'OG000'}, {'value': '6.3125', 'spread': '5.055937104', 'groupId': 'OG001'}]}]}, {'title': 'Post graduate year 1: Change after 8 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-1.266666667', 'spread': '2.865226659', 'groupId': 'OG000'}, {'value': '-1.8125', 'spread': '4.354595274', 'groupId': 'OG001'}]}]}, {'title': 'Post graduate year 2: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.461538462', 'spread': '4.502136245', 'groupId': 'OG000'}, {'value': '9.615384615', 'spread': '4.233565509', 'groupId': 'OG001'}]}]}, {'title': 'Post graduate year 2: Change after 8 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.846153846', 'spread': '3.262058497', 'groupId': 'OG000'}, {'value': '-0.076923077', 'spread': '2.985005261', 'groupId': 'OG001'}]}]}, {'title': 'Post graduate year 3: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.2', 'spread': '5.031330412', 'groupId': 'OG000'}, {'value': '8.933333333', 'spread': '5.470265946', 'groupId': 'OG001'}]}]}, {'title': 'Post graduate year 3: Change after 8 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.933333333', 'spread': '3.788453636', 'groupId': 'OG000'}, {'value': '0.4', 'spread': '3.581699517', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 8 weeks', 'description': 'The change in the Depersonalization (DP) burnout score(as measured by the Maslach Burnout Inventory (MBI))from baseline to end of each exercise phase stratified by training level.\n\nMBI-HSS is a survey to measure burnout in professionals in human services. DP MBI-HSS includes 5 items to evaluate depersonalization (DP) with scores ranging from 0 to 6 on the Likert scale. MBI-HSS DP total score ranges from 0 to 30 points. We consider a high degree of burnout in the case of DP ≥ 10. Moderate burnout will be considered in the case of 6\\<DP\\<9 points. Low levels will be considered for DP≤5 points.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'There were 16 PGY1, 13 PGY2, and 15 PGY3 participants in study. Data available in 15 PGY1 participants in exercise intervention period.'}, {'type': 'PRIMARY', 'title': 'The Change in the Personal Accomplishment (PA) Burnout Score(as Measured by the Maslach Burnout Inventory (MBI))From Baseline to End of Each Exercise Phase Stratified by Training Level.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '44', 'groupId': 'OG000'}, {'value': '43', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Exercise Intervention', 'description': 'Prescribed Exercise Program: Brief cardiovascular exercise training (\\>70% of maximum heart rate) for 15 minutes a day, 5 days a week for 8 weeks.\n\nThe exercise intervention will be a 15-minute per day of vigorous exercise that as monitored by a Fitbit Charge 2.\n\nExamples of possible 15-minute exercise regimens to be used include:\n\n* Walking quickly or running up and down stairs\n* Plyometric exercises such as jumping jacks, high knees, squats, lunges, speed skaters, froggers, etc\n* Walking up an incline on a treadmill\n* Jogging or running on a treadmill or elliptical\n* Stationary cycling or rowing'}, {'id': 'OG001', 'title': 'Usual Exercise Program', 'description': 'Usual Exercise Program: Usual exercise activity for 8 weeks'}], 'classes': [{'title': 'Post graduate year 1: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '16', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33', 'spread': '7.456540753', 'groupId': 'OG000'}, {'value': '34.2', 'spread': '7.775419144', 'groupId': 'OG001'}]}]}, {'title': 'Post graduate year 1: Change after 8 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '-0.2', 'spread': '6.635402884', 'groupId': 'OG000'}, {'value': '1.428571429', 'spread': '5.243520334', 'groupId': 'OG001'}]}]}, {'title': 'Post graduate year 2: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '36.15384615', 'spread': '6.2695847', 'groupId': 'OG000'}, {'value': '36.38461538', 'spread': '6.776656766', 'groupId': 'OG001'}]}]}, {'title': 'Post graduate year 2: Change after 8 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '13', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '1', 'spread': '4.795831523', 'groupId': 'OG000'}, {'value': '1', 'spread': '5.016638981', 'groupId': 'OG001'}]}]}, {'title': 'Post graduate year 3: Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '33.6', 'spread': '6.344851681', 'groupId': 'OG000'}, {'value': '34.46666667', 'spread': '6.998639324', 'groupId': 'OG001'}]}]}, {'title': 'Post graduate year 3: Change after 8 weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '0.466666667', 'spread': '7.199867724', 'groupId': 'OG000'}, {'value': '-0.133333333', 'spread': '5.962581735', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to 8 weeks', 'description': 'The change in the PA burnout score(as measured by the Maslach Burnout Inventory (MBI))from baseline to end of each exercise phase stratified by training level.\n\nMBI-HSS is a survey to measure burnout in professionals in human services. PA MBI-HSS includes 8 items to evaluate personal accomplishment (PA), with scores ranging from 0 to 6 on the Likert scale. MBI-HSS PA total score ranges from 0 to 48 points. We consider a high degree of burnout in the case of PA≥ 39 points. Moderate burnout will be considered in the case of 32-38 PA points. Low levels will be considered for PA ≤31 points.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'There were 16 PGY1, 13 PGY2, and 15 PGY3 participants in study. Data available in 15 PGY1 participants for change in exercise intervention period and baseline in usual exercise period, and change in 13 participants after usual exercise program.'}, {'type': 'PRIMARY', 'title': 'The Degree of Burnout Among VUMC Anesthesia Interns and Residents as Quantified by Baseline Emotional Exhaustion (EE) MBI-HSS Scores Broken Down by Level of Residency Training Completed.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Post Graduate Year 1', 'description': 'VUMC anesthesia post medical school graduate year 1'}, {'id': 'OG001', 'title': 'Post Graduate Year 2', 'description': 'VUMC anesthesia post medical school graduate year 2'}, {'id': 'OG002', 'title': 'Post Graduate Year 3', 'description': 'VUMC anesthesia post medical school graduate year 3'}], 'classes': [{'categories': [{'measurements': [{'value': '20.29412', 'spread': '8.858363', 'groupId': 'OG000'}, {'value': '16.80000', 'spread': '10.255312', 'groupId': 'OG001'}, {'value': '27.64286', 'spread': '12.481415', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'The degree of burnout among VUMC anesthesia interns and residents as quantified by baseline Emotional Exhaustion MBI-HSS scores broken down by level of residency training completed.\n\nMBI-HSS is a survey to measure burnout in professionals in human services. MBI-HSS EE score includes 9 items to evaluate emotional exhaustion (EE), with scores ranging from 0 to 6 on the Likert scale. MBI-HSS EE total score ranges from 0 to 54 points. We consider a high degree of burnout in the case of EE ≥ 27 points. Moderate burnout will be considered in the case of 26\\<EE\\<19 points. Low levels will be considered for EE≤18 points.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'The Degree of Burnout Among VUMC Anesthesia Interns and Residents as Quantified by Baseline Depersonalization MBI-HSS Scores Broken Down by Level of Residency Training Completed.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Post Graduate Year 1', 'description': 'VUMC anesthesia post medical school graduate year 1'}, {'id': 'OG001', 'title': 'Post Graduate Year 2', 'description': 'VUMC anesthesia post medical school graduate year 2'}, {'id': 'OG002', 'title': 'Post Graduate Year 3', 'description': 'VUMC anesthesia post medical school graduate year 3'}], 'classes': [{'categories': [{'measurements': [{'value': '7.647059', 'spread': '5.086025', 'groupId': 'OG000'}, {'value': '6.266667', 'spread': '4.817626', 'groupId': 'OG001'}, {'value': '9.357143', 'spread': '6.570413', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'The degree of burnout among VUMC anesthesia interns and residents as quantified by baseline Depersonalization MBI-HSS scores broken down by level of residency training completed.\n\nMBI-HSS is a survey to measure burnout in professionals in human services. MBI-HSS DP score includes 5 items to evaluate depersonalization (DP) with scores ranging from 0 to 6 on the Likert scale. MBI-HSS DP total score ranges from 0 to 30 points. We consider a high degree of burnout in the case of DP≥ 13 points. Moderate burnout will be considered in the case of 7-12 DP points. Low levels will be considered for DP ≤6 points.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'The Degree of Burnout Among VUMC Anesthesia Interns and Residents as Quantified by Baseline Personal Accomplishment (PA) MBI-HSS Scores Broken Down by Level of Residency Training Completed.', 'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}, {'value': '14', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Post Graduate Year 1', 'description': 'VUMC anesthesia post medical school graduate year 1'}, {'id': 'OG001', 'title': 'Post Graduate Year 2', 'description': 'VUMC anesthesia post medical school graduate year 2'}, {'id': 'OG002', 'title': 'Post Graduate Year 3', 'description': 'VUMC anesthesia post medical school graduate year 3'}], 'classes': [{'categories': [{'measurements': [{'value': '34.41176', 'spread': '6.828788', 'groupId': 'OG000'}, {'value': '34.60000', 'spread': '8.584038', 'groupId': 'OG001'}, {'value': '33.35714', 'spread': '9.352969', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline', 'description': 'The degree of burnout among VUMC anesthesia interns and residents as quantified by baseline Personal Accomplishment MBI-HSS scores broken down by level of residency training completed.\n\nMBI-HSS is a survey to measure burnout in professionals in human services. MBI-HSS PA score includes 8 items to evaluate Personal Accomplishment (PA) with scores ranging from 0 to 6 on the Likert scale. MBI-HSS PA total score ranges from 0 to 48 points. We consider a high degree of burnout in the case of PA≥ 39 points. Moderate burnout will be considered in the case of 32-38 DP points. Low levels will be considered for DP ≤31 points.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Arm A: Exercise Intervention Then Usual Exercise Program', 'description': '8 weeks of exercise intervention followed by 8 weeks of usual exercise program'}, {'id': 'FG001', 'title': 'Arm B: Usual Exercise Program Then Exercise Intervention', 'description': '8 weeks of usual exercise program followed by 8 weeks of exercise intervention'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '24'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '22'}, {'groupId': 'FG001', 'numSubjects': '22'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'Two participants were randomized to intervention arm followed by control arm. These participants withdrew from the study after the start of the intervention arm and never started the control arm.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Exercise Intervention Then Usual Exercise Program', 'description': '8 weeks of exercise intervention followed by 8 weeks of usual exercise program'}, {'id': 'BG001', 'title': 'Usual Exercise Program Then Exercise Intervention', 'description': '8 weeks of usual exercise program followed by 8 weeks of exercise intervention'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Female', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}]}, {'title': 'Male', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '10', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}, {'title': 'Not reported', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'denoms': [{'units': 'Participants', 'counts': [{'value': '24', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '46', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-06-18', 'size': 698114, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2019-11-12T15:22', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'balanced order-randomized, 16-week within-subject crossover study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 46}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2018-12-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-01', 'studyFirstSubmitDate': '2018-03-29', 'resultsFirstSubmitDate': '2020-02-21', 'studyFirstSubmitQcDate': '2018-03-29', 'lastUpdatePostDateStruct': {'date': '2020-04-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2020-04-01', 'studyFirstPostDateStruct': {'date': '2018-04-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2020-04-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Change in the Emotional Exhaustion (EE) Burnout Score(as Measured by the Maslach Burnout Inventory (MBI)From Baseline to End of Each Exercise Phase.', 'timeFrame': 'Baseline to 8 weeks', 'description': 'The change in the Emotional Exhaustion (EE) burnout score(as measured by the Maslach Burnout Inventory (MBI)from baseline to end of each exercise phase.\n\nMBI-HSS is a survey to measure burnout in professionals in human services. MBI-HSS EE score includes 9 items to evaluate emotional exhaustion (EE), with scores ranging from 0 to 6 on the Likert scale. MBI-HSS EE total score ranges from 0 to 54 points. We consider a high degree of burnout in the case of EE ≥ 27 points. Moderate burnout will be considered in the case of 26\\<EE\\<19 points. Low levels will be considered for EE≤18 points.'}, {'measure': 'The Change in the Depersonalization (DP) Burnout Score(as Measured by the Maslach Burnout Inventory (MBI))From Baseline to End of Each Exercise Phase.', 'timeFrame': 'Baseline to 8 weeks', 'description': 'The change in the Depersonalization (DP) burnout score(as measured by the Maslach Burnout Inventory (MBI))from baseline to end of each exercise phase.\n\nMBI-HSS is a survey to measure burnout in professionals in human services. MBI-HSS DP score includes 5 items to evaluate depersonalization (DP) with scores ranging from 0 to 6 on the Likert scale. MBI-HSS DP total score ranges from 0 to 30 points. We consider a high degree of burnout in the case of DP≥ 13 points. Moderate burnout will be considered in the case of 7-12 DP points. Low levels will be considered for DP ≤6 points.'}, {'measure': 'The Change in the Personal Accomplishment (PA) Burnout Score(as Measured by the Maslach Burnout Inventory (MBI))From Baseline to End of Each Exercise Phase.', 'timeFrame': 'Baseline to 8 weeks', 'description': 'The change in the Personal Accomplishment (PA) burnout score(as measured by the Maslach Burnout Inventory (MBI))from baseline to end of each exercise phase.\n\nMBI-HSS is a survey to measure burnout in professionals in human services. MBI-HSS PA score includes 8 items to evaluate Personal Accomplishment (PA) with scores ranging from 0 to 6 on the Likert scale. MBI-HSS PA total score ranges from 0 to 48 points. We consider a high degree of burnout in the case of PA≥ 39 points. Moderate burnout will be considered in the case of 32-38 PA points. Low levels will be considered for PA ≤31 points.'}, {'measure': 'Change in the Emotional Exhaustion (EE) Burnout Score(as Measured by MBI From Baseline to End of Each Exercise Phase Stratified by Training Level (Post Graduate Year 1 (PGY1), Post Graduate Year 2 (PGY2), and Post Graduate Year 3 (PGY3))', 'timeFrame': 'Baseline to 8 weeks', 'description': 'The change in the Emotional Exhaustion burnout score(as measured by the Maslach Burnout Inventory (MBI)from baseline to end of each exercise phase stratified by training level.\n\nMBI-HSS is a survey to measure burnout in professionals in human services. MBI-HSS includes 9 items to evaluate emotional exhaustion (EE) with scores ranging from 0 to 6 on the Likert scale. MBI-HSS EE total score ranges from 0 to 54 points. We consider a high degree of burnout in the case of EE ≥ 27 points. Moderate burnout will be considered in the case of 26\\<EE\\<19 points. Low levels will be considered for EE≤18 points.'}, {'measure': 'The Change in the Depersonalization (DP) Burnout Score(as Measured by the Maslach Burnout Inventory (MBI))From Baseline to End of Each Exercise Phase Stratified by Training Level.', 'timeFrame': 'Baseline to 8 weeks', 'description': 'The change in the Depersonalization (DP) burnout score(as measured by the Maslach Burnout Inventory (MBI))from baseline to end of each exercise phase stratified by training level.\n\nMBI-HSS is a survey to measure burnout in professionals in human services. DP MBI-HSS includes 5 items to evaluate depersonalization (DP) with scores ranging from 0 to 6 on the Likert scale. MBI-HSS DP total score ranges from 0 to 30 points. We consider a high degree of burnout in the case of DP ≥ 10. Moderate burnout will be considered in the case of 6\\<DP\\<9 points. Low levels will be considered for DP≤5 points.'}, {'measure': 'The Change in the Personal Accomplishment (PA) Burnout Score(as Measured by the Maslach Burnout Inventory (MBI))From Baseline to End of Each Exercise Phase Stratified by Training Level.', 'timeFrame': 'Baseline to 8 weeks', 'description': 'The change in the PA burnout score(as measured by the Maslach Burnout Inventory (MBI))from baseline to end of each exercise phase stratified by training level.\n\nMBI-HSS is a survey to measure burnout in professionals in human services. PA MBI-HSS includes 8 items to evaluate personal accomplishment (PA), with scores ranging from 0 to 6 on the Likert scale. MBI-HSS PA total score ranges from 0 to 48 points. We consider a high degree of burnout in the case of PA≥ 39 points. Moderate burnout will be considered in the case of 32-38 PA points. Low levels will be considered for PA ≤31 points.'}, {'measure': 'The Degree of Burnout Among VUMC Anesthesia Interns and Residents as Quantified by Baseline Emotional Exhaustion (EE) MBI-HSS Scores Broken Down by Level of Residency Training Completed.', 'timeFrame': 'Baseline', 'description': 'The degree of burnout among VUMC anesthesia interns and residents as quantified by baseline Emotional Exhaustion MBI-HSS scores broken down by level of residency training completed.\n\nMBI-HSS is a survey to measure burnout in professionals in human services. MBI-HSS EE score includes 9 items to evaluate emotional exhaustion (EE), with scores ranging from 0 to 6 on the Likert scale. MBI-HSS EE total score ranges from 0 to 54 points. We consider a high degree of burnout in the case of EE ≥ 27 points. Moderate burnout will be considered in the case of 26\\<EE\\<19 points. Low levels will be considered for EE≤18 points.'}, {'measure': 'The Degree of Burnout Among VUMC Anesthesia Interns and Residents as Quantified by Baseline Depersonalization MBI-HSS Scores Broken Down by Level of Residency Training Completed.', 'timeFrame': 'Baseline', 'description': 'The degree of burnout among VUMC anesthesia interns and residents as quantified by baseline Depersonalization MBI-HSS scores broken down by level of residency training completed.\n\nMBI-HSS is a survey to measure burnout in professionals in human services. MBI-HSS DP score includes 5 items to evaluate depersonalization (DP) with scores ranging from 0 to 6 on the Likert scale. MBI-HSS DP total score ranges from 0 to 30 points. We consider a high degree of burnout in the case of DP≥ 13 points. Moderate burnout will be considered in the case of 7-12 DP points. Low levels will be considered for DP ≤6 points.'}, {'measure': 'The Degree of Burnout Among VUMC Anesthesia Interns and Residents as Quantified by Baseline Personal Accomplishment (PA) MBI-HSS Scores Broken Down by Level of Residency Training Completed.', 'timeFrame': 'Baseline', 'description': 'The degree of burnout among VUMC anesthesia interns and residents as quantified by baseline Personal Accomplishment MBI-HSS scores broken down by level of residency training completed.\n\nMBI-HSS is a survey to measure burnout in professionals in human services. MBI-HSS PA score includes 8 items to evaluate Personal Accomplishment (PA) with scores ranging from 0 to 6 on the Likert scale. MBI-HSS PA total score ranges from 0 to 48 points. We consider a high degree of burnout in the case of PA≥ 39 points. Moderate burnout will be considered in the case of 32-38 DP points. Low levels will be considered for DP ≤31 points.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Burnout, Professional', 'Burnout Syndrome']}, 'descriptionModule': {'briefSummary': 'This study seeks to evaluate the prevalence and characterize predictors of physician burnout in the anesthesia residency at Vanderbilt University Medical Center. The study also seeks to evaluate the effect of an exercise intervention on burnout and personal resiliency (i.e., less individual stress given the same workload).', 'detailedDescription': 'A cross-sectional evaluation of burnout, perceived stress, average sleep propensity, and social support and coping mechanisms will be assessed from four years of Vanderbilt University Medical Center (VUMC) Anesthesia residents. Burnout will be assessed using the Maslach Burnout Inventory (MBI-HSS).\n\nParticipating interns, Anesthesia Residency Class 1 (CA-1), and Anesthesia Residency Class 2 (CA-2) classes will be randomized to 8 weeks of an exercise intervention (15 min of activity at 70% of max heart rate or higher, 5 days a week) to meet the activity recommendations of the Office of Disease Prevention and Health Promotion or 8 weeks of continuing their baseline activity level prior to the study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Vanderbilt University Medical Center Anesthesiology residents (Class 1(CA-1), Class 2 (CA-2)\n\nExclusion Criteria:\n\n* Failure to sign informed consent\n* Will not be in town and available for the full duration of the study (e.g., 2 or more weeks of vacation or absence)\n* Physical inability to perform the exercise intervention (including health indications)'}, 'identificationModule': {'nctId': 'NCT03489720', 'briefTitle': 'Evaluation of a Daily Brief Exercise Intervention on Resident Physician Personal Resiliency and Burnout', 'organization': {'class': 'OTHER', 'fullName': 'Vanderbilt University Medical Center'}, 'officialTitle': 'Evaluation of a Daily Brief Exercise Intervention on Resident Physician Personal Resiliency and Burnout', 'orgStudyIdInfo': {'id': '180313'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm A: Exercise intervention then usual exercise program', 'description': '8 weeks of exercise intervention followed by 8 weeks of usual exercise program', 'interventionNames': ['Behavioral: Prescribed Exercise Program', 'Behavioral: Usual Exercise Program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Arm B: Usual Exercise Program then exercise intervention', 'description': '8 weeks of usual exercise program followed by 8 weeks of exercise intervention', 'interventionNames': ['Behavioral: Prescribed Exercise Program', 'Behavioral: Usual Exercise Program']}], 'interventions': [{'name': 'Prescribed Exercise Program', 'type': 'BEHAVIORAL', 'description': 'Brief cardiovascular exercise training (\\>70% of maximum heart rate) for 15 minutes a day, 5 days a week for 8 weeks.\n\nThe exercise intervention will be a 15-minute per day of vigorous exercise that as monitored by a Fitbit Charge 2.\n\nExamples of possible 15-minute exercise regimens to be used include:\n\n* Walking quickly or running up and down stairs\n* Plyometric exercises such as jumping jacks, high knees, squats, lunges, speed skaters, froggers, etc\n* Walking up an incline on a treadmill\n* Jogging or running on a treadmill or elliptical\n* Stationary cycling or rowing', 'armGroupLabels': ['Arm A: Exercise intervention then usual exercise program', 'Arm B: Usual Exercise Program then exercise intervention']}, {'name': 'Usual Exercise Program', 'type': 'BEHAVIORAL', 'description': 'Usual exercise activity for 8 weeks', 'armGroupLabels': ['Arm A: Exercise intervention then usual exercise program', 'Arm B: Usual Exercise Program then exercise intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt Unversity Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}], 'overallOfficials': [{'name': 'Uma Shastri, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vanderbilt University Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vanderbilt University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Anesthesiology', 'investigatorFullName': 'Uma Shastri', 'investigatorAffiliation': 'Vanderbilt University Medical Center'}}}}