Clinical trial NCT06086028: LA-CEAL 4.0: Wearable Sensor Project
Official title: LA-CEAL 4.0: Louisiana (LA) Community-Engagement Research Alliance (CEAL): Wearable Sensor Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health Care Workforce Burn Out
Stress
Keywords: Health care workforce
Burn out
Stress
Wearable sensors
Lead sponsor: Tulane University
Sponsor class: OTHER
First posted: 2023-10-17
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Change in mean in readiness to change composite score between immediate information and delayed information periods.
timeFrame: 6 weeks
Secondary outcomes:
measure: Change in burnout score from baseline to 6 weeks
timeFrame: Baseline - 6 weeks
Other outcomes:
measure: Change in mean score on participant burnout score between study arms
timeFrame: Baseline - 6 weeks
measure: Change in mean score on participant depression score between study arms
timeFrame: Baseline - 6 weeks
measure: Change in mean score on participant anxiety score between study arms
timeFrame: Baseline - 6 weeks
measure: Change in mean score on participant resilience score between study arms.
timeFrame: Baseline - 6 weeks
measure: Change in mean on participant sleep score between conditions
timeFrame: Baseline - 6 weeks
measure: Change in mean on participant activity level score between conditions
timeFrame: Baseline - 6 weeks
measure: Change in mean on participant respiratory rate between conditions
timeFrame: Baseline - 6 weeks
measure: Change in mean on participant Heart Rate Variability (HRV) between conditions
timeFrame: Baseline - 6 weeks
measure: Change in mean on participant heart rate between conditions
timeFrame: Baseline - 6 weeks
Locations:
city: New Orleans
country: United States
facility: Tulane School of Public Health and Tropical Medicine
state: Louisiana
Study officials:
affiliation: Tulane University
name: Marie Krousel-Wood, MD, MSPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
citation: Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
citation: Sinclair VG, Wallston KA. The development and psychometric evaluation of the Brief Resilient Coping Scale. Assessment. 2004 Mar;11(1):94-101. doi: 10.1177/1073191103258144.
citation: Maslach, C., Jackson, S. E., & Leiter, M. P. (1997). Maslach Burnout Inventory: Third edition. In C. P. Zalaquett & R. J. Wood (Eds.), Evaluating stress: A book of resources (pp. 191-218). Scarecrow Education