LA-CEAL 4.0: Wearable Sensor Project

Stress Clinical Trial

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

Status Active, not recruiting

Clinical Trial Summary

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.

Clinical Trial 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). ;

Related Conditions & MeSH terms

• Burnout, Psychological
• Stress

• NCT number: NCT06086028
• Study type: Interventional
• Source: Tulane University
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 20, 2023
• Completion date: May 31, 2024