FatigueIoT4ResidentNCT03354871
Developing Models for Fatigue Monitoring in Obstetrics and Gyne- Cology Residents Using Wearables
An observational study of Fatigue, run by Hillel Yaffe Medical Center at 1 site in Israel.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Fatigue
- How many people
- 6 participants
- Where
- 1 siteIsrael
- Study dates
- Nov 2017to 28 Feb 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Obstetrics and gynecology residents in duty
Who may be able to join
- Participants will be chosen from the obstetrics and gynecology department in the Hillel Yaffe medical center.
Who cannot join
- Chronic fatigue syndrome
- Pregnancy
Trial locations and contacts
1 site in 1 country.
Mordechai Hallak, M.D contact
Israel1 site
Department of Obstetrics and Gynecology, Hillel-Yaffe Medical Center
Hadera, 38100
About this study
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.
Read the 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.
- Conditions
- Fatigue
- Medical subject headings
- Fatigue
What is being measured
The primary outcome is the main question the study is designed to answer.
Fatigue determination model.
A model for detecting abnormal fatigue alert.
Measured: Through study completion, an average of 1 year.
Secondary outcomes (1)
Fatigue based fit-to-task model.
Model for estimation of for seen task performance.
Measured: Through study completion, an average of 1 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2017
- Study startNov 2017 (estimated)
- Primary completion31 Jan 2018 (estimated)
- Study completion28 Feb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for FatigueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hillel Yaffe Medical Center
- Sponsor type
- Other government
- Collaborators
- International Business Machines (IBM)
- Responsible party
- Sponsor
- Investigators
- Mordechai Hallak, M.D, Principal investigator, Department of Obstetrics & Gynecology, Hillel Yaffe Medical Center, Hadera
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03354871
- Sponsor's protocol ID
- 0081-17-HYMC
- Acronym
- IoT4Resident
- Status last verified
- Nov 2017
- First submitted
- 16 Nov 2017
- Last updated
- 28 Nov 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bundele, Mahesh M., and Rahul Banerjee.
Szypulska, Małgorzata, and Zbigniew Piotrowski.
Study at a glance
From the registry record, last updated by the sponsor on 28 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing Models for Fatigue Monitoring in Obstetrics and Gyne- Cology Residents Using Wearables
- ClinicalTrials.gov ID
- NCT03354871
- Acronym / sponsor ID
- IoT4Resident / 0081-17-HYMC
- Conditions
- Fatigue
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Hillel Yaffe Medical CenterOther government
- Collaborators
- International Business Machines (IBM)
- Study start
- Nov 2017 (estimated)
- Primary completion
- 31 Jan 2018 (estimated)
- Study completion
- 28 Feb 2018 (estimated)
- First posted
- 28 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Obstetrics and gynecology residents in duty
Key inclusion criteria (1 listed)
- Participants will be chosen from the obstetrics and gynecology department in the Hillel Yaffe medical center.
Key exclusion criteria (2 listed)
- Chronic fatigue syndrome
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Fatigue determination model.
Time frame: Through study completion, an average of 1 year.
A model for detecting abnormal fatigue alert.
1 secondary outcome
Fatigue based fit-to-task model.
Time frame: Through study completion, an average of 1 year.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Nov 2017.
- BackgroundBundele, Mahesh M., and Rahul Banerjee.
- BackgroundSzypulska, Małgorzata, and Zbigniew Piotrowski.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mordechai Hallak, M.D contact
Mordechai Hallak, M.D principal investigator
Department of Obstetrics & Gynecology, Hillel Yaffe Medical Center, Hadera
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fatigue, run by Hillel Yaffe Medical Center at 1 site in Israel.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ofer Limonad, M.D (00972525322972, oferlimonad@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fatigue determination model. (time frame: Through study completion, an average of 1 year.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03354871, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Nov 2017.