LA-CEAL 4.0: Wearable Sensor Project

NCT06086028 | Completed Results

• 1 other identifier: 2023-9-19
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Health Care Workforce Burn Out; Stress

Keywords

Health care workforce; Burn out; Stress; Wearable sensors

Outcome Measures

Primary Outcomes (1)

• Percentage of Days in Concordance Comparing Immediate Information Period With Delayed Information Period

  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).

  6 weeks

Secondary Outcomes (1)

• Change in Burnout Score From Baseline to Follow-up (Pre/Post Sensor Data Collection)

  Baseline - 6 weeks

Other Outcomes (9)

• Change in Mean in Total Burnout Score of Immediate Then Delayed Arm to Delayed Then Immediate Arm

  Baseline - 6 weeks

• Change in Mean in Total Depression Score of Immediate Then Delayed Arm to Delayed Then Immediate Arm

  Baseline - 6 weeks

• Change in Mean in Total Anxiety Score of Immediate Then Delayed Arm to Delayed Then Immediate Arm

  Baseline - 6 weeks

Study Arms (2)

Immediate then Delayed Arm

EXPERIMENTAL

The participants will receive immediate access to the data from the wearable sensor for 21 days. On day 22, all of the data from the wearable sensor will be hidden from the participant (delayed) until after the second 21-day feedback period. Wrist worn sensor: Biostrap collects biometrics such as the following: (1) sleep pattern/ quality; (2) steps, activity, calories; (3) heart rate/ HRV; (4) respiratory rate.

Other: Wrist worn sensor

Delayed then Immediate Arm

EXPERIMENTAL

The participants begin the first 21-day feedback period with their data from the wearable sensor hidden (delayed feedback). On day 22, the wearable sensor changes to become available in real time (immediate feedback) for the second 21-day feedback period. Wrist worn sensor: Biostrap collects biometrics such as the following: (1) sleep pattern/ quality; (2) steps, activity, calories; (3) heart rate/ HRV; (4) respiratory rate.

Other: Wrist worn sensor

Interventions

Wrist worn sensor OTHER

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.

Delayed then Immediate Arm; Immediate then Delayed Arm

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tulane University: lead

Study Sites (1)

Tulane School of Public Health and Tropical Medicine

New Orleans, Louisiana, 70112, United States

Location

Related Publications (4)

• 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.

  PMID: 11556941 BACKGROUND

• 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.

  PMID: 16717171 BACKGROUND

• 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.

  PMID: 14994958 BACKGROUND

• 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

  BACKGROUND

MeSH Terms

Conditions

Burnout, Psychological

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Results Point of Contact

• Title: Leia Y. Saltzman Associate Professor
• Organization: Tulane University

lsaltzman@tulane.edu

504-247-1452

Study Officials

• Marie Krousel-Wood, MD, MSPH

  Tulane University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 10, 2023
• First Posted: October 17, 2023
• Study Start: November 20, 2023
• Primary Completion: May 31, 2024
• Study Completion: May 31, 2024
• Last Updated: October 20, 2025
• Results First Posted: October 20, 2025

Record last verified: 2025-09

Locations

US (1)