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

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.

Study Overview

• Status: Unknown
• Conditions: 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.

• Study Type: Observational
• Enrollment (Anticipated): 6

Contacts and Locations

Study Locations

• Israel
  • Hadera, Israel, 38100
    • Department of Obstetrics and Gynecology, Hillel-Yaffe Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Obstetrics and gynecology residents in duty

Description

Inclusion Criteria:

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

Exclusion Criteria:

• Chronic fatigue syndrome
• Pregnancy

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fatigue determination model.	A model for detecting abnormal fatigue alert.	Through study completion, an average of 1 year.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fatigue based fit-to-task model.	Model for estimation of for seen task performance.	Through study completion, an average of 1 year.

Collaborators and Investigators

• Sponsor: Hillel Yaffe Medical Center
• Collaborators: International Business Machines (IBM)
• Investigators: Principal Investigator: Mordechai Hallak, M.D, Department of Obstetrics & Gynecology, Hillel Yaffe Medical Center, Hadera

Publications and helpful links

General Publications

• Bundele, Mahesh M., and Rahul Banerjee.
• Szypulska, Małgorzata, and Zbigniew Piotrowski.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2017
• Primary Completion (Anticipated): January 31, 2018
• Study Completion (Anticipated): February 28, 2018

Study Registration Dates

• First Submitted: November 16, 2017
• First Submitted That Met QC Criteria: November 27, 2017
• First Posted (Actual): November 28, 2017

Study Record Updates

• Last Update Posted (Actual): November 28, 2017
• Last Update Submitted That Met QC Criteria: November 27, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Fatigue
• Other Study ID Numbers: 0081-17-HYMC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No