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

Fatigue Clinical Trial

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Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03354871
• Other study ID #: 0081-17-HYMC
• Status: Not yet recruiting
• Phase: N/A
• First received: November 16, 2017
• Last updated: November 27, 2017
• Start date: November 2017
• Est. completion date: February 28, 2018

Study information

• Verified date: November 2017
• Source: Hillel Yaffe Medical Center
• Contact: Ofer Limonad, M.D
• Phone: 00972525322972
• Email: oferlimonad[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 6
• Est. completion date: February 28, 2018
• Est. primary completion date: January 31, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• Chronic fatigue syndrome

• Pregnancy

Related Conditions & MeSH terms

• Fatigue

Locations

Country	Name	City	State
Israel	Department of Obstetrics and Gynecology, Hillel-Yaffe Medical Center	Hadera

Sponsors (2)

Lead Sponsor	Collaborator
Hillel Yaffe Medical Center	International Business Machines (IBM)

Country where clinical trial is conducted

Israel, 

References & Publications (2)

Bundele, Mahesh M., and Rahul Banerjee.

Szypulska, Malgorzata, and Zbigniew Piotrowski.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fatigue determination model.	A model for detecting abnormal fatigue alert.	Through study completion, an average of 1 year.
Secondary	Fatigue based fit-to-task model.	Model for estimation of for seen task performance.	Through study completion, an average of 1 year.

External Links

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