LA-CEAL 4.0: Wearable Sensor Project
- Conditions
- Health Care Workforce Burn OutStress
- Interventions
- Other: Wrist worn sensor
- 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 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 80
- 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.
- 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
- Arm && Interventions
Group Intervention Description Delayed access start arm Wrist worn sensor 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. Real time access start arm Wrist worn sensor 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.
- Primary Outcome Measures
Name Time Method Change in mean in readiness to change composite score between immediate information and delayed information periods. 6 weeks 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.
- Secondary Outcome Measures
Name Time Method Change in burnout score from baseline to 6 weeks Baseline - 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.
Trial Locations
- Locations (1)
Tulane School of Public Health and Tropical Medicine
🇺🇸New Orleans, Louisiana, United States