Trial Outcomes & Findings for LA-CEAL 4.0: Wearable Sensor Project (NCT NCT06086028)

1 participant in delayed access start arm did not respond to this question.

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).

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.

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.

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.

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.

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.

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

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.

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.

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.

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.