Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Marie Krousel-Wood, MD, MSPH | Tulane University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Tulane School of Public Health and Tropical Medicine | New Orleans | Louisiana | 70112 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11556941 | Background | 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. | |
| 16717171 | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Immediate Then Delayed Arm | The participants received immediate access to the data from the wearable sensor for 21 days. On day 22, all of the data from the wearable sensor was hidden from the participant (delayed) until after the second 21-day feedback period. Wrist worn sensor: Biostrap collected biometrics such as the following: (1) sleep pattern/ quality; (2) steps, activity, calories; (3) heart rate/ HRV; (4) respiratory rate. |
| FG001 | Delayed Then Immediate Arm | The participants began the first 21-day feedback period with their data from the wearable sensor hidden (delayed feedback). On day 22 the wearable sensor changed to become available in real time (immediate feedback) for the second 21-day feedback period. Wrist worn sensor: Biostrap collected biometrics such as the following: (1) sleep pattern/ quality; (2) steps, activity, calories; (3) heart rate/ HRV; (4) respiratory rate. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | 1 participant in delayed access start arm did not respond to this question. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Cross-over design. 71 participants were monitored during both immediate and delayed information periods. | Posted | Mean | Standard Deviation | % of days concordant | 6 weeks |
|
Not provided
All-Cause Mortality, Serious, and Other [Not Including Serious] Adverse Events were not systematically monitored/assessed.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Immediate Information Period | Three week period during which each participant was able to view their sensor data in real time. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Leia Y. Saltzman Associate Professor | Tulane University | 504-247-1452 | lsaltzman@tulane.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 20, 2023 | May 28, 2025 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 20, 2023 | May 28, 2025 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D000077062 | Burnout, Psychological |
| ID | Term |
|---|---|
| D013315 | Stress, Psychological |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Baseline - 6 weeks |
| Baseline - 6 weeks |
| 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. | Baseline - 6 weeks |
| 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. | Baseline - 6 weeks |
| 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. | Baseline - 6 weeks |
| 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 | 6 weeks |
| 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. | 6 weeks |
| 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. | 6 weeks |
| 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. | 6 weeks |
| 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. | 6 weeks |
| 14994958 | 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. |
| 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 |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Age, Continuous | 1 participant in delayed access start arm did not respond to this question | Mean | Standard Deviation | years |
|
| Sex: Female, Male | 1 participant in the delayed access start arm did not respond to this question | Count of Participants | Participants |
|
| Race (NIH/OMB) | 1 participant in the delayed access start arm did not respond to this question | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| OG000 |
| Immediate Information Period |
Three week period during which each participant was able to view their sensor data in real time. |
| OG001 | Delayed Information Period | Three week period during which each participant was not able to view their sensor data in real time. They were able to view their data after the delayed information period. |
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | Change in score on a scale | Baseline - 6 weeks |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | Change in score on a scale | Baseline - 6 weeks |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | Change in score on a scale | Baseline - 6 weeks |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | Change in score on a scale | Baseline - 6 weeks |
|
|
|
| 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. | 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. | Posted | Mean | Standard Deviation | Change in score on a scale | Baseline - 6 weeks |
|
|
|
| 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 | Cross-over design. 69 participants monitored during both immediate and delayed information periods. | Posted | Mean | Standard Deviation | Change in score on a scale | 6 weeks |
|
|
|
| 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. | Cross-over design. 69 participants monitored in both immediate and delayed information periods. | Posted | Mean | Standard Deviation | Change in score on a scale | 6 weeks |
|
|
|
| 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. | Cross-over design. 71 participants monitored in both immediate and delayed information periods. | Posted | Mean | Standard Deviation | Breaths per minute | 6 weeks |
|
|
|
| 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. | Cross-over design. 71 participants monitored in both immediate and delayed information periods. | Posted | Mean | Standard Deviation | Milliseconds | 6 weeks |
|
|
|
| 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. | Cross-over design. 71 participants monitored in both immediate and delayed information periods. | Posted | Mean | Standard Deviation | Beats per minute | 6 weeks |
|
|
|
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | Delayed Information Period | Three week period during which each participant was not able to view their sensor data in real time. They were able to view their data after the delayed information period. | 0 | 0 | 0 | 0 | 0 | 0 |
Not provided
Not provided
Not provided
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|