Skip to content

LA-CEAL 4.0: Wearable Sensor Project

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06086028
Enrollment
80
Registered
2023-10-17
Start date
2023-11-20
Completion date
2024-05-31
Last updated
2025-10-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Care Workforce Burn Out, Stress

Keywords

Health care workforce, Burn out, Stress, Wearable sensors

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 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).

Interventions

OTHERWrist 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.

Sponsors

Tulane University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Percentage of Days in Concordance Comparing Immediate Information Period With Delayed Information Period6 weeksThe 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

MeasureTime frameDescription
Change in Burnout Score From Baseline to Follow-up (Pre/Post Sensor Data Collection)Baseline - 6 weeksThe 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

MeasureTime frameDescription
Change in Mean in Total Anxiety Score of Immediate Then Delayed Arm to Delayed Then Immediate ArmBaseline - 6 weeksThe 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.
Change in Mean in Total Resilience Score of Immediate Then Delayed Arm to Delayed Then Immediate ArmBaseline - 6 weeksThe 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.
Change in Mean on Participant Sleep Score Between Immediate Information Period and Delayed Information Period6 weeksThe 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
Change in Mean in Total Burnout Score of Immediate Then Delayed Arm to Delayed Then Immediate ArmBaseline - 6 weeksThe 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.
Change in Respiratory Rate Between Immediate Information Period and Delayed Information Period6 weeksRespiratory 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.
Change in Participant Heart Rate Variability (HRV) Between Immediate Information Period and Delayed Information Period6 weeksHRV 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.
Change in Participant Heart Rate Between Immediate Information Period and Delayed Information Period6 weeksHeart 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.
Change in Mean on Participant Activity Level Score Between Immediate Information Period and Delayed Information Period6 weeksActivity 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.
Change in Mean in Total Depression Score of Immediate Then Delayed Arm to Delayed Then Immediate ArmBaseline - 6 weeksThe 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.

Countries

United States

Participant flow

Participants by arm

ArmCount
Immediate Then Delayed Arm
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.
40
Delayed Then Immediate Arm
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.
40
Total80

Withdrawals & dropouts

PeriodReasonFG000FG001
Overall StudyLost to Follow-up23
Overall StudyWithdrawal by Subject11

Baseline characteristics

CharacteristicDelayed Then Immediate ArmTotalImmediate Then Delayed Arm
Age, Categorical
<=18 years
0 Participants0 Participants0 Participants
Age, Categorical
>=65 years
2 Participants5 Participants3 Participants
Age, Categorical
Between 18 and 65 years
37 Participants74 Participants37 Participants
Age, Continuous44.92 years
STANDARD_DEVIATION 10.28
45.51 years
STANDARD_DEVIATION 11.4
46.08 years
STANDARD_DEVIATION 12.51
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants2 Participants2 Participants
Race (NIH/OMB)
Asian
1 Participants1 Participants0 Participants
Race (NIH/OMB)
Black or African American
16 Participants30 Participants14 Participants
Race (NIH/OMB)
More than one race
0 Participants1 Participants1 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants0 Participants0 Participants
Race (NIH/OMB)
Unknown or Not Reported
1 Participants3 Participants2 Participants
Race (NIH/OMB)
White
21 Participants42 Participants21 Participants
Region of Enrollment
United States
40 Participants80 Participants40 Participants
Sex: Female, Male
Female
36 Participants72 Participants36 Participants
Sex: Female, Male
Male
3 Participants7 Participants4 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
0 / 00 / 0
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 0

Outcome results

Primary

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).

Time frame: 6 weeks

Population: Cross-over design. 71 participants were monitored during both immediate and delayed information periods.

ArmMeasureValue (MEAN)Dispersion
Immediate Information PeriodPercentage of Days in Concordance Comparing Immediate Information Period With Delayed Information Period0.49 % of days concordantStandard Deviation 0.03
Delayed Information PeriodPercentage of Days in Concordance Comparing Immediate Information Period With Delayed Information Period0.50 % of days concordantStandard Deviation 0.29
Secondary

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

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.

Time frame: Baseline - 6 weeks

Population: 57 participants responded to the burnout scale on baseline and 6 weeks follow-up assessment. For this outcome measure, the burnout scale was given at baseline and at 6 weeks follow up, it was not reassessed at crossover, so the investigators didn't calculate the scale for the conditions assessed for each arm to be reported separately.

ArmMeasureValue (MEAN)Dispersion
Immediate Information PeriodChange in Burnout Score From Baseline to Follow-up (Pre/Post Sensor Data Collection)38.82 Change in score on a scaleStandard Deviation 18.48
Delayed Information PeriodChange in Burnout Score From Baseline to Follow-up (Pre/Post Sensor Data Collection)35.54 Change in score on a scaleStandard Deviation 20.24
Other Pre-specified

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

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.

Time frame: Baseline - 6 weeks

Population: 74 participants responded to the anxiety question at baseline and 6 weeks follow-up assessments. For this outcome measure, the total anxiety score was given at baseline and at 6 weeks follow up, it was not reassessed at crossover, so the investigators didn't calculate the score for the conditions assessed for each arm to be reported separately.

ArmMeasureValue (MEAN)Dispersion
Immediate Information PeriodChange in Mean in Total Anxiety Score of Immediate Then Delayed Arm to Delayed Then Immediate Arm-0.05 Change in score on a scaleStandard Deviation 1.31
Delayed Information PeriodChange in Mean in Total Anxiety Score of Immediate Then Delayed Arm to Delayed Then Immediate Arm-0.06 Change in score on a scaleStandard Deviation 1.49
Other Pre-specified

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

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.

Time frame: Baseline - 6 weeks

Population: 57 participants responded to the burnout scale on baseline and 6 weeks follow-up assessment. For this outcome measure, the total burnout score was given at baseline and at 6 weeks follow up, it was not reassessed at crossover, so the investigators didn't calculate the score for the conditions assessed for each arm to be reported separately.

ArmMeasureValue (MEAN)Dispersion
Immediate Information PeriodChange in Mean in Total Burnout Score of Immediate Then Delayed Arm to Delayed Then Immediate Arm-2.03 Change in score on a scaleStandard Deviation 11.61
Delayed Information PeriodChange in Mean in Total Burnout Score of Immediate Then Delayed Arm to Delayed Then Immediate Arm-4.88 Change in score on a scaleStandard Deviation 16.01
Other Pre-specified

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

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.

Time frame: Baseline - 6 weeks

Population: 74 participants responded to the depression questionnaire at both baseline and 6 weeks follow-up. For this outcome measure, the depression score was given at baseline and at 6 weeks follow up, it was not reassessed at crossover, so the investigators didn't calculate the score for the conditions assessed for each arm to be reported separately.

ArmMeasureValue (MEAN)Dispersion
Immediate Information PeriodChange in Mean in Total Depression Score of Immediate Then Delayed Arm to Delayed Then Immediate Arm0.08 Change in score on a scaleStandard Deviation 1
Delayed Information PeriodChange in Mean in Total Depression Score of Immediate Then Delayed Arm to Delayed Then Immediate Arm-0.17 Change in score on a scaleStandard Deviation 1.18
Other Pre-specified

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

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.

Time frame: Baseline - 6 weeks

Population: 73 participants responded to the resilience questions on baseline and 6 weeks follow-up assessments. For this outcome measure, the total resilience score was given at baseline and at 6 weeks follow up, it was not reassessed at crossover, so the investigators didn't calculate the score for the conditions assessed for each arm to be reported separately.

ArmMeasureValue (MEAN)Dispersion
Immediate Information PeriodChange in Mean in Total Resilience Score of Immediate Then Delayed Arm to Delayed Then Immediate Arm0.42 Change in score on a scaleStandard Deviation 2.54
Delayed Information PeriodChange in Mean in Total Resilience Score of Immediate Then Delayed Arm to Delayed Then Immediate Arm0.71 Change in score on a scaleStandard Deviation 1.54
Other Pre-specified

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

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.

Time frame: 6 weeks

Population: Cross-over design. 69 participants monitored in both immediate and delayed information periods.

ArmMeasureValue (MEAN)Dispersion
Immediate Information PeriodChange in Mean on Participant Activity Level Score Between Immediate Information Period and Delayed Information Period62.21 Change in score on a scaleStandard Deviation 22.12
Delayed Information PeriodChange in Mean on Participant Activity Level Score Between Immediate Information Period and Delayed Information Period60.54 Change in score on a scaleStandard Deviation 23.22
Other Pre-specified

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

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

Time frame: 6 weeks

Population: Cross-over design. 69 participants monitored during both immediate and delayed information periods.

ArmMeasureValue (MEAN)Dispersion
Immediate Information PeriodChange in Mean on Participant Sleep Score Between Immediate Information Period and Delayed Information Period79.11 Change in score on a scaleStandard Deviation 13.88
Delayed Information PeriodChange in Mean on Participant Sleep Score Between Immediate Information Period and Delayed Information Period77.21 Change in score on a scaleStandard Deviation 16.35
Other Pre-specified

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

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.

Time frame: 6 weeks

Population: Cross-over design. 71 participants monitored in both immediate and delayed information periods.

ArmMeasureValue (MEAN)Dispersion
Immediate Information PeriodChange in Participant Heart Rate Between Immediate Information Period and Delayed Information Period79.00 Beats per minuteStandard Deviation 7.01
Delayed Information PeriodChange in Participant Heart Rate Between Immediate Information Period and Delayed Information Period79.32 Beats per minuteStandard Deviation 7.75
Other Pre-specified

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

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.

Time frame: 6 weeks

Population: Cross-over design. 71 participants monitored in both immediate and delayed information periods.

ArmMeasureValue (MEAN)Dispersion
Immediate Information PeriodChange in Participant Heart Rate Variability (HRV) Between Immediate Information Period and Delayed Information Period32.63 MillisecondsStandard Deviation 14.93
Delayed Information PeriodChange in Participant Heart Rate Variability (HRV) Between Immediate Information Period and Delayed Information Period33.06 MillisecondsStandard Deviation 15.73
Other Pre-specified

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

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.

Time frame: 6 weeks

Population: Cross-over design. 71 participants monitored in both immediate and delayed information periods.

ArmMeasureValue (MEAN)Dispersion
Immediate Information PeriodChange in Respiratory Rate Between Immediate Information Period and Delayed Information Period16.96 Breaths per minuteStandard Deviation 2
Delayed Information PeriodChange in Respiratory Rate Between Immediate Information Period and Delayed Information Period16.95 Breaths per minuteStandard Deviation 1.95

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026