NCT03354871

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
6

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2017

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

November 16, 2017

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 28, 2017

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2018

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2018

Completed
Last Updated

November 28, 2017

Status Verified

November 1, 2017

Enrollment Period

3 months

First QC Date

November 16, 2017

Last Update Submit

November 27, 2017

Conditions

Fatigue

Outcome Measures

Primary Outcomes (1)

  • Fatigue determination model.

    A model for detecting abnormal fatigue alert.

    Through study completion, an average of 1 year.

Secondary Outcomes (1)

  • Fatigue based fit-to-task model.

    Through study completion, an average of 1 year.

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Obstetrics and gynecology residents in duty

You may qualify if:

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

You may not qualify if:

  • Chronic fatigue syndrome
  • Pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Obstetrics and Gynecology, Hillel-Yaffe Medical Center

Hadera, 38100, Israel

Location

Related Publications (2)

  • Bundele, Mahesh M., and Rahul Banerjee.

    BACKGROUND

  • Szypulska, Małgorzata, and Zbigniew Piotrowski.

    BACKGROUND

MeSH Terms

Conditions

Fatigue

Condition Hierarchy (Ancestors)

Signs and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Mordechai Hallak, M.D

    Department of Obstetrics & Gynecology, Hillel Yaffe Medical Center, Hadera

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ofer Limonad, M.D

CONTACT

00972525322972oferlimonad@gmail.com

Mordechai Hallak, M.D

CONTACT

MottiH@hy.health.gov.il

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2017

First Posted

November 28, 2017

Study Start

November 1, 2017

Primary Completion

January 31, 2018

Study Completion

February 28, 2018

Last Updated

November 28, 2017

Record last verified: 2017-11

Data Sharing

IPD Sharing
Will not share

Locations

IL(1)