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Developing Models for Fatigue Monitoring in Obstetrics and Gyne- Cology Residents Using Wearables (IoT4Resident)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03354871
Recruitment Status : Unknown
Verified November 2017 by Hillel Yaffe Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : November 28, 2017
Last Update Posted : November 28, 2017
Sponsor:
Collaborator:
International Business Machines (IBM)
Information provided by (Responsible Party):
Hillel Yaffe Medical Center

Brief Summary:
This study is set out to observe heart-rate and related bio-metric indicators in Obstetrics and Gynecology residents during their duty hours, together with self-reporting of fatigue and tasks performances, in order to model possible relationships between the two.

Condition or disease
Fatigue

Detailed Description:
There are vast evidences of the harmful consequences of fatigue in medical residents, consequently, leading to poor task performances and in some cases may cause injury to the patients. Medically, fatigue is a non-specific symptom, which means that it has many possible causes and accompanies many different conditions. Elevated fatigue is an indication that a person may not be fit-to-task (i.e., task efficacy).The investigators main goal is to use readily available body-worn sensors, such as an activity wrist-band, to continuously monitor for fatigue as a possible antecedent to predictions of task-efficacy in the area of Obstetrics and Gynecology. This study is anchored in prior research which established basic models that correlate between heart-rate variability (HRV) and fatigue. Specific to this study, the investigators would like to further establish the validity of such models at the individual level, also with the perspective of fatigue as an early predictor of task performance related to practices in Obstetrics and Gynecology. The investigators aim is to extend HRV based models with additional personal measures (e.g., age, weight, activity level), possibly with the extraction of additional data-driven features, to improve model accuracy at the individual level. The investigators will also try to find relationships between such measurements and task effectiveness via the gathering of self-reports regarding on-the-job task performances.

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Study Type : Observational
Estimated Enrollment : 6 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Developing Models for Fatigue Monitoring in Obstetrics and Gyne- Cology Residents Using Wearables
Estimated Study Start Date : November 2017
Estimated Primary Completion Date : January 31, 2018
Estimated Study Completion Date : February 28, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fatigue




Primary Outcome Measures :
  1. Fatigue determination model. [ Time Frame: Through study completion, an average of 1 year. ]
    A model for detecting abnormal fatigue alert.


Secondary Outcome Measures :
  1. Fatigue based fit-to-task model. [ Time Frame: Through study completion, an average of 1 year. ]
    Model for estimation of for seen task performance.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Obstetrics and gynecology residents in duty
Criteria

Inclusion Criteria:

  • Participants will be chosen from the obstetrics and gynecology department in the Hillel Yaffe medical center.

Exclusion Criteria:

  • Chronic fatigue syndrome
  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03354871


Contacts
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Contact: Ofer Limonad, M.D 00972525322972 oferlimonad@gmail.com
Contact: Mordechai Hallak, M.D MottiH@hy.health.gov.il

Locations
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Israel
Department of Obstetrics and Gynecology, Hillel-Yaffe Medical Center
Hadera, Israel, 38100
Sponsors and Collaborators
Hillel Yaffe Medical Center
International Business Machines (IBM)
Investigators
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Principal Investigator: Mordechai Hallak, M.D Department of Obstetrics & Gynecology, Hillel Yaffe Medical Center, Hadera
Additional Information:
Publications:
Bundele, Mahesh M., and Rahul Banerjee.
Szypulska, Małgorzata, and Zbigniew Piotrowski.

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Responsible Party: Hillel Yaffe Medical Center
ClinicalTrials.gov Identifier: NCT03354871    
Other Study ID Numbers: 0081-17-HYMC
First Posted: November 28, 2017    Key Record Dates
Last Update Posted: November 28, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fatigue
Signs and Symptoms