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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02950363
Other study ID # IRB-16-6803
Secondary ID
Status Completed
Phase N/A
First received July 6, 2016
Last updated August 24, 2017
Start date July 2016
Est. completion date July 2017

Study information

Verified date March 2017
Source Scripps Translational Science Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to determine whether use of a suite of smart phone enabled mobile health devices can reduce burnout in medical trainees. Such applications can then be used in more general populations with the same goal in mind.


Description:

Wearable sensors and mental health platforms delivered via smartphones offer an opportunity to passively and actively acquire quantifiable signs and symptoms related to mental health status. These features include both physiological and cognitive performance measures. Collectively they serve as a set of metrics whereby an estimation of a person's mental state can be gauged. Additionally, use of these platforms allows those who are identified as high risk for mental illness to have targeted therapy delivered via their smartphone and if necessary connected with a suitable healthcare provider. Applications of such technology platforms serve to potentially reduce the substantial morbidity and mortality in a population at increased risk for mental illness and burnout.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date July 2017
Est. primary completion date May 2017
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 19 Years and older
Eligibility Inclusion Criteria:

- Trainee Physician at Scripps Green Hospital or Clinic.

- Older than 18 years.

- Must be reliable, cooperative and willing to comply with all protocol-specified procedures.

- Able to understand and grant informed consent

- Have a pre-existing smart phone capable of running all study software.

Exclusion Criteria:

- Has a significant medical condition that in the investigator's opinion may interfere with the study subject's optimal participation in the study.

- Known mental health condition including diagnosis of depression, schizophrenia, suicidality or anxiety disorder.

- Does not have suitable smart phone to allow all relevant software to run.

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
United States Scripps Health San Diego California

Sponsors (2)

Lead Sponsor Collaborator
Scripps Translational Science Institute The Scripps Research Institute

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary The primary endpoint is change in Maslach Burnout Inventory (MBI) over a 16 week period as measured at time points Week 0 (Baseline), 4, 10, 16. Maslach Burnout Inventory Week 0 (Baseline), 4, 10, 16
Secondary Change in PHQ9 Score - (Raw score - No units) as measured at time points Week 0 (Baseline), 4, 10, 16. Change in PHQ9 Score over 3 months. Week 0 (Baseline), 4, 10, 16
Secondary Relationship of absolute PHQ9 Score at weeks 4, 10 & 16 to a series of biometrics as described below: Average, following measurement of score:
total time (Hours & Minutes) slept/night for week % sleep score (to Oura Ring App) per night for week min. overnight lowest heart rate (Beats per minute) per night for week
Total time of per night for week:
deep sleep (Hours & Minutes) light sleep (Hours & Minutes) REM sleep (Hours & Minutes) waking (Hours & Minutes) sleep latency (Hours & Minutes)
% readiness score (% Measure native to Oura Ring App)
Daily number of minutes of:
focus (measured by Spire App) for week tension (measured by Spire App) for week calm (measured by Spire App) for week activity (measured by Spire App) for week inactivity (measured by Spire App) for week daily calories burned (measured by Spire App) for week
Weekly # of (measured by the Beyond Verbal App):
positive mood recordings negative mood recordings neutral mood recordings weekly arousal, temper, and valance score
Weeks 4, 10 & 16
Secondary Relationship of MBI score - 3 sub scales at weeks 4, 10 & 16 to a series of biometrics as described below: Average, following measurement of score:
total time (Hours & Minutes) slept/night for week % sleep score (to Oura Ring App) per night for week min. overnight lowest heart rate (Beats per minute) per night for week
Total time of per night for week:
deep sleep (Hours & Minutes) light sleep (Hours & Minutes) REM sleep (Hours & Minutes) waking (Hours & Minutes) sleep latency (Hours & Minutes)
% readiness score (% Measure native to Oura Ring App)
Daily number of minutes of:
focus (measured by Spire App) for week tension (measured by Spire App) for week calm (measured by Spire App) for week activity (measured by Spire App) for week inactivity (measured by Spire App) for week daily calories burned (measured by Spire App) for week
Weekly # of (measured by the Beyond Verbal App):
positive mood recordings negative mood recordings neutral mood recordings weekly arousal, temper, and valance score
Weeks 4, 10 & 16
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