LA-CEAL 4.0: Wearable Sensor Project

Not Applicable

Completed

• Conditions: Health Care Workforce Burn Out; Stress

• Registration Number: NCT06086028
• Lead Sponsor: Tulane University

Brief 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.

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 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).

Study Timeline

• Study First Submitted: 2023-10-10
• Study First Submitted QC: 2023-10-10
• Study First Posted: 2023-10-17
• Study Start: 2023-11-20
• Primary Completion: 2024-05-31
• Study Completion: 2024-05-31
• Results First Submitted: 2025-05-30
• Status Verified: 2025-09
• Results First Submitted QC: 2025-09-30
• Last Update Submitted: 2025-09-30
• Results First Posted: 2025-10-20
• Last Update Posted: 2025-10-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Percentage of Days in Concordance Comparing Immediate Information Period With Delayed Information Period	6 weeks	The proportion of days in concordance was calculated based on responses to two questions. The first question seeks to determine if participants accurately understand their biometric data and will ask "how stressed are you today?" (Scale 1-10 a score of 6+ was coded as "high stress"). 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 = 1 /no = 0). Concordance was coded when participants either a) reported a high level of stress and engaged in self-care or b) when participants reported low levels of stress and did not engage in self-care. Percentage of days in concordance was calculated for both 21-day feedback periods (immediate versus delayed).

Secondary Outcome Measures

Name	Time	Method
Change in Burnout Score From Baseline to Follow-up (Pre/Post Sensor Data Collection)	Baseline - 6 weeks	The investigators measured the change in the burnout score in all participants between baseline and 6 weeks follow-up. 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 (0), 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 (6). The total score is calculated by summing the three sub-scales and ranges from 0-132 with high scores reflecting higher symptoms of burnout and low scores reflecting fewer symptoms of burnout.

Trial Locations

Locations (1)

Tulane School of Public Health and Tropical Medicine; 🇺🇸 New Orleans, Louisiana, United States