LA-CEAL 4.0: Wearable Sensor Project

Study Overview
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Brief Summary
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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.

Detailed Description
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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).

Official Title
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LA-CEAL 4.0: Louisiana (LA) Community-Engagement Research Alliance (CEAL): Wearable Sensor Project

Conditions
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Health Care Workforce Burn Out, Stress

Intervention / Treatment
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* Other: Wrist worn sensor


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Real time access start arm<br>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<br>* 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.<br>|
| Experimental: Delayed access start arm<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in mean in readiness to change composite score between immediate information and delayed information periods. | The composite score is a combination of study arm, real time or delayed release information with 2 questions from the questioner. 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 higher score in readiness to change would mean that the bio feedback is helping participants in allowing people to understand and act to mitigate stress. | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in burnout score from baseline to 6 weeks | The investigators will measure the change in the burnout score in all participants between baseline and 6 weeks. Maslach Burnout Inventory - Human Services Survey for Medical Personnel (MBI-HSS-MP) is a 22-item survey that covers 3 areas: Emotional Exhaustion (EE), Depersonalization (DP), and low sense of Personal Accomplishment (PA). Each subscale includes multiple questions with frequency rating choices of Never, A few times a year or less, Once a month or less, A few times a month, Once a week, A few times a week, or Every day. The high score reflect higher symptoms of burnout and low score reflects fewer symptoms of burnout. | Baseline - 6 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Health care workforce, Burn out, Stress, Wearable sensors