Purpose

The study seeks to explore the efficacy of biofeedback collected via a wrist worn sensor in helping healthcare workers self-manage symptoms of stress and burnout.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 100 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Age >=18 years. - Ability to understand and speak English. - Staff at FQHC. - Smartphone compatible with the Biostrap sensor and phone application. - Attending work during the six week study period.

Exclusion Criteria

  • Unable or unwilling to give informed consent. - Disclosed pregnancy at the start of the study. - Pace maker or other device regulation heart rate/rhythm. - Previous diagnosis of atrial fibrillation.

Study Design

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover Assignment
Primary Purpose
Other
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Real time access start arm
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.
  • Other: Wrist worn sensor
    Biostrap collects biometrics such as the following: (1) sleep pattern/ quality; (2) steps, activity, calories; (3) heart rate/ HRV; (4) respiratory rate. Participants will be randomly assigned to one of two groups.
Experimental
Delayed access start arm
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.
  • Other: Wrist worn sensor
    Biostrap collects biometrics such as the following: (1) sleep pattern/ quality; (2) steps, activity, calories; (3) heart rate/ HRV; (4) respiratory rate. Participants will be randomly assigned to one of two groups.

More Details

Status
Active, not recruiting
Sponsor
Tulane University

Study Contact

Detailed Description

A randomized two-group cross over design will be used to test the hypothesis that using real-time biofeedback to present, interpret, and bring attention to information regarding stress levels will increase participants readiness to change in regard to addressing burnout. To test this hypothesis, the investigators will recruit 80 providers from Federally Qualified Health Centers (FQHC) partner sites to participate in a 6-week cross over design. The six-week timeline for Arm 1 includes: (1) a 7-day orientation; (2) 14 days condition 1 (immediate information condition); (3) 7 day "washout"; and (4) 14 days condition 2 (delayed information condition). All participants will be given a wrist worn sensor developed by Biostrap. Biostrap collects biometrics such as the following: (1) sleep pattern/ quality; (2) steps, activity, calories; (3) heart rate/ Heart Rate Variability (HRV); (4) respiratory rate. Participants will be randomly assigned to one of two groups. Arm 1 will receive real-time access to their biometric data via the Biostrap Application Programming Interface (API) (immediate information condition) while Arm 2 is blinded to their biometrics until the control period is over (information delayed condition). After 1 week "washout" the Arms will cross-over, and Arm 2 will receive real-time access to their biometrics via the Biostrap API while Arm 1 is blinded to their biometric report until the end of the control period. While wearing the Biostrap wrist-worn sensor, participants will be asked to complete two daily questions sent via the API. The first question seeks to determine if participants accurately understand their biometric data and will ask "how stressed are you today?" (Scale 1-10). The second question seeks to determine if participants attended to the information regarding their stress level and will ask "did you complete a self-care activity today?" (yes/no). A pre and post assessment will be given before and after completing the six-week wearable protocol. Items will include: (1) 2-item depression screener (Patient Health Questionnaire-revised)1 (2) 2-item anxiety screener (Generalized Anxiety Disorder Scale- revised)2 (3) 4-item brief resilient coping scale. (4) 22-item burnout assessment (Maslach Burnout Inventory)4 (5) Self-care/supportive psychosocial programs utilization(e.g., I participate in an employee wellness program through my employer) (yes/no) (6) Basic demographics (e.g., age, sex, race, ethnicity, job category, years in field) (7) Familiarity and self-efficacy using wearable sensors (8) Self- report medication list (pre test only).

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.