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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06086028
• Other study ID #: 2023-9-19
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 20, 2023
• Est. completion date: May 31, 2024

Study information

• Verified date: April 2024
• Source: Tulane University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: May 31, 2024
• Est. primary completion date: May 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Burnout, Psychological
• Stress

Intervention

Other:
• 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. Participants will be randomly assigned to one of two groups.

Locations

Country	Name	City	State
United States	Tulane School of Public Health and Tropical Medicine	New Orleans	Louisiana

Sponsors (1)

Lead Sponsor	Collaborator
Tulane University

Country where clinical trial is conducted

United States, 

References & 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. — View 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

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in mean score on participant burnout score between study arms	The investigators will measure the change in the burnout score in all participants between the 2 arms to compare the difference across the groups. 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.	Baseline - 6 weeks
Other	Change in mean score on participant depression score between study arms	The investigators will measure the change in the depression score in all participants between the 2 arms to compare the difference across the groups. The score is a 2-item depression screener (Patient Health Questionnaire-revised). The range is from 0 to 6. The high score reflect higher symptoms of depression and low score reflects fewer symptoms of depression.	Baseline - 6 weeks
Other	Change in mean score on participant anxiety score between study arms	The investigators will measure the change in the anxiety score in all participants between the 2 arms to compare the difference across the groups. The score is a 2-item anxiety screener (Generalized Anxiety Disorder Scale- revised). The range is from 0 to 6. The high score reflect higher symptoms of anxiety and low score reflects fewer symptoms of anxiety.	Baseline - 6 weeks
Other	Change in mean score on participant resilience score between study arms.	The investigators will measure the change in the participant resilience score in all participants between the 2 arms to compare the difference across the groups. The score is a 4-item brief resilient coping scale (Sinclaire and Wallston, 2004). The range is from 0 to 16. The high score reflect higher resilience and low score reflects lower resilience.	Baseline - 6 weeks
Other	Change in mean on participant sleep score between conditions	The investigators will measure the change in the participant sleep efficiency score in all participants between the 2 arms to compare the difference across the groups. Sleep efficiency score is measured via the wearable sensor. It is comprised of the following information: sleep duration (end-start), minutes in light sleep, minutes in deep sleep, stages of sleep (e.g. REM), arousal count. The range is from 0 to 100. Higher sleep efficiency scores reflect better quality sleep. Low sleep efficiency scores reflect poor quality of sleep	Baseline - 6 weeks
Other	Change in mean on participant activity level score between conditions	The investigators will measure the change in the participant activity level score in all participants between the 2 arms to compare the difference across the groups. Activity level is measured by number of steps and distance measured by the wearable sensors. Higher scores reflect more activity while lower scores reflect less activity	Baseline - 6 weeks
Other	Change in mean on participant respiratory rate between conditions	The investigators will measure the change in the participant activity respiratory rate in all participants between the 2 arms to compare the difference across the groups. Respiratory rate is measured as breathing rate per minute and is recorded via the wearable sensor. Higher values reflect faster breathing which is a proxy measure of stress while lower values reflect slower breathing.	Baseline - 6 weeks
Other	Change in mean on participant Heart Rate Variability (HRV) between conditions	The investigators will measure the change in the participant Heart Rate Variability (HRV) in all participants between the 2 arms to compare the difference across the groups. HRV is calculated using root mean square of successive differences (rMSSD) using beats per minute recorded via the wearable sensor. HRV scale is 0-255. Normal scores depend on age and sex. HRV is used as a proxy measure of stress and cardiovascular health.	Baseline - 6 weeks
Other	Change in mean on participant heart rate between conditions	The investigators will measure the change in the participant heart rate in all participants between the 2 arms to compare the difference across the groups. Heart rate is measured as beats per minute and is recorded by the wearable sensor. High values reflect faster pulse while lower values reflect lower pulse. Normal ranges for resting adult heart rate is 60 to 100. Higher heart rate is a proxy measure for stress and anxiety.	Baseline - 6 weeks
Primary	Change in mean in readiness to change composite score between immediate information and delayed information periods.	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.	6 weeks
Secondary	Change in burnout score from baseline to 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.	Baseline - 6 weeks