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Completed

NCT Number: NCT06086028

LA-CEAL 4.0: Wearable Sensor Project

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.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tulane School of Public Health and Tropical Medicine

New Orleans, Louisiana, 70112, United States

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. Percentage of Days in Concordance Comparing Immediate Information Period With Delayed Information Period

    Time frame: 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 outcomes

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

    Time frame: 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.

Other outcomes

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

    Time frame: Baseline - 6 weeks

    The investigators measured the mean in the total burnout score of the immediate then delayed arm to the delayed then immediate arm. 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.

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

    Time frame: Baseline - 6 weeks

    The investigators compared the mean in total depression score of immediate then delayed arm to delayed then immediate arm. The score is a 2-item depression screener (Patient Health Questionnaire-revised). The range is from 0 to 6. The high scores reflect higher symptoms of depression, and low scores reflect fewer symptoms of depression.

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

    Time frame: Baseline - 6 weeks

    The investigators compared the mean in total anxiety score of immediate then delayed arm to delayed then immediate arm. The score is a 2-item anxiety screener (Generalized Anxiety Disorder Scale- revised). The range is from 0 to 6. The high scores reflect higher symptoms of anxiety, and low scores reflect fewer symptoms of anxiety.

  4. Change in Mean in Total Resilience Score of Immediate Then Delayed Arm to Delayed Then Immediate Arm

    Time frame: Baseline - 6 weeks

    The investigators compared the mean in total resilience score of immediate then delayed arm to delayed then immediate arm. The score is a 4-item brief resilient coping scale. The range is from 4 to 20. The high scores reflect higher resilience, and low scores reflect lower resilience.

  5. Change in Mean on Participant Sleep Score Between Immediate Information Period and Delayed Information Period

    Time frame: 6 weeks

    The investigators measured the change in the participant sleep efficiency score in all participants between the 2 conditions to compare the difference across the conditions. 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

  6. Change in Mean on Participant Activity Level Score Between Immediate Information Period and Delayed Information Period

    Time frame: 6 weeks

    Activity level was measured by number of steps and distance measured by the wearable sensors. Higher scores reflect more activity while lower scores reflect less activity. An average of the daily activity level scores was calculated for each information period. Biostrap company calculated the activity score using the activity distribution over the course of a 24-hour window, emphasizing consistent physical activity of 500 steps per hour during 12 unique hours. There are no scale ranges for this activity score.

  7. Change in Respiratory Rate Between Immediate Information Period and Delayed Information Period

    Time frame: 6 weeks

    Respiratory rate was measured as breathing rate per minute and was recorded via the wearable sensor. Higher values reflect faster breathing which is a proxy measure of stress while lower values reflect slower breathing. An average respiratory rate was calculated for each information period.

  8. Change in Participant Heart Rate Variability (HRV) Between Immediate Information Period and Delayed Information Period

    Time frame: 6 weeks

    HRV was 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. An average HRV was calculated for each information period.

  9. Change in Participant Heart Rate Between Immediate Information Period and Delayed Information Period

    Time frame: 6 weeks

    Heart rate is measured as beats per minute and was 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. An average heart rate was calculated for each information period.

Sponsors and collaborators

Lead sponsor

Tulane University

Other

Registry information

Official study title

LA-CEAL 4.0: Louisiana (LA) Community-Engagement Research Alliance (CEAL): Wearable Sensor Project

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 17, 2023
Registry last updated
Oct 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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