LA-CEAL 4.0: Wearable Sensor Project

Tulane University

Status: Completed

Conditions: Health Care Workforce Burn Out; Stress

Treatments: Other: Wrist worn sensor

Study type: Interventional

Funder types: Other

Identifiers

NCT06086028

2023-9-19

Details and patient eligibility

About

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.

Full 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 study includes two feedback periods: (1) 21 days of immediate information: (2) 21 days delayed information period. Participant conditions will be switched on day 22. 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, and either receive immediate or delayed feedback from the sensor first and will then be crossed-over to receive the opposite type of feedback. 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) (2) 2-item anxiety screener (Generalized Anxiety Disorder Scale- revised) (3) 4-item brief resilient coping scale (4) 22-item burnout assessment (Maslach Burnout Inventory) (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 (pretest only).

Enrollment: 80 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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80 participants in 2 patient groups

Immediate then Delayed Arm

Experimental group

Description:

The participants will receive immediate access to the data from the wearable sensor for 21 days. On day 22, all of the data from the wearable sensor will be hidden from the participant (delayed) until after the second 21-day feedback period. 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.

Treatment:

Other: Wrist worn sensor

Delayed then Immediate Arm

Experimental group

Description:

The participants begin the first 21-day feedback period with their data from the wearable sensor hidden (delayed feedback). On day 22, the wearable sensor changes to become available in real time (immediate feedback) for the second 21-day feedback period. 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.

Treatment:

Other: Wrist worn sensor