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Wearable Stress Monitor for Stress Management

N/A

Recruiting

Led By Marie Krousel-Wood, MD, MSPH

Research Sponsored by Tulane University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age >=18 years

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks

Awards & highlights

Study Summary

This trial looks at how using a wrist monitor can help healthcare workers manage stress and burnout.

Who is the study for?

This trial is for healthcare workers at FQHC, aged 18 or older, who can understand and speak English. They must have a smartphone compatible with the Biostrap sensor and app, and be working during the six-week study. Pregnant individuals, those unable to consent, with pacemakers or diagnosed atrial fibrillation cannot join.Check my eligibility

What is being tested?

The trial is testing if a wrist-worn sensor can help healthcare workers manage stress and burnout by providing biofeedback on their physical state. Participants will use this technology over a period of six weeks to monitor their well-being.See study design

What are the potential side effects?

Since this intervention involves wearing a sensor and using an app rather than taking medication or undergoing medical procedures, side effects are minimal but may include discomfort from wearing the device or anxiety from monitoring symptoms.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in mean in readiness to change composite score between immediate information and delayed information periods.

Secondary outcome measures

Change in burnout score from baseline to 6 weeks

Other outcome measures

Change in mean on participant Heart Rate Variability (HRV) between conditions

Change in mean on participant activity level score between conditions

Change in mean on participant heart rate between conditions

+6 more

Trial Design

2Treatment groups

Experimental Treatment

Group I: Real time access start armExperimental Treatment1 Intervention

The participants will receive real-time access to their biometric data via the Biostrap API (immediate information condition). After 1 week "washout" the arms will cross-over, and the delayed access start arm will receive real-time access to their biometrics via the Biostrap API while real time access start arm is blinded to their biometric report until the end of the control period.

Group II: Delayed access start armExperimental Treatment1 Intervention

The participants are blinded to their biometrics until the control period is over (information delayed condition). After 1 week "washout" the arms will cross-over, and the delayed access start arm will receive real-time access to their biometrics via the Biostrap API while real time access start arm is blinded to their biometric report until the end of the control period.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Tulane UniversityLead Sponsor

115 Previous Clinical Trials

226,422 Total Patients Enrolled

Marie Krousel-Wood, MD, MSPHPrincipal InvestigatorTulane University

2 Previous Clinical Trials

106 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does the protocol of this medical experiment permit participation from individuals over 50 years old?

"This trial has an age cutoff of 18 years and is open to patients under the century mark."

Answered by AI

Could I potentially qualify for participation in this medical experiment?

"For consideration in this clinical trial, potential participants must demonstrate symptoms of burnout syndrome and fall within the age limit of 18 to 100. This medical study is currently recruiting up to 80 individuals."

Answered by AI

Is there capacity to enroll new participants in this research program?

"The current status of this trial, posted on October 1st 2023 and recently updated on 10th October 2023, is not actively recruiting. Nevertheless, there are 187 other studies seeking participants at present time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

LA-CEAL 4.0: Wearable Sensor Project

2023. "LA-CEAL 4.0: Wearable Sensor Project". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06086028.

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