The purpose of this study is to explore the use of digital health technology for measuring symptoms and daily health in people with primary biliary cholangitis (PBC). Biometric data captured with a wearable device will be compared to questionnaire responses (patient-reported outcomes, or PROs) and laboratory test results to test the hypothesis that changes in biometrics can be correlated to changes in disease activity.
Patients enrolled are intended to start a second-line therapy (2L) for control of their PBC - the choice of therapy will be at the discretion of the treating hepatologist. Once 2L therapy is initiated, the study will assess for correlations between changes in biochemistries (alkaline phosphatase, or ALP) with biometrics and PRO results.
Study Type
OBSERVATIONAL
Enrollment
30
Stanford University School of Medicine
Redwood City, California, United States
Sleep scores to assess sleep quality will be measured in PBC patients using a wearable device
Sleep Score 0 - 100 where 0 is worst sleep experience and 100 is best sleep experience
Time frame: 7 months (1 month of screening and 6 months wearing device)
SpO2 (saturation of peripheral oxygen) levels to assess sleep quality
Time frame: 7 months (1 month of screening and 6 months wearing device)
Total time in bed, to assess sleep quality
Number of hours per day spent in bed
Time frame: 7 months (1 month of screening and 6 months wearing device)
Total sleep, to assess sleep quality
Number of hours per day spent asleep
Time frame: 7 months (1 month of screening and 6 months wearing device)
Sleep stage time series (REM), to assess sleep quality
Number of hours per day spent in REM (Rapid Eye Movement) sleep
Time frame: 7 months (1 month of screening and 6 months wearing device)
Sleep stage time series (deep), to assess sleep quality
Number of hours per day spent in deep sleep
Time frame: 7 months (1 month of screening and 6 months wearing device)
Sleep stage time series (light), to assess sleep quality
Number of hours per day spent in light sleep
Time frame: 7 months (1 month of screening and 6 months wearing device)
Number of "get ups" during sleep, to assess sleep quality
Number of times "getting up" during the night while trying to sleep
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Time frame: 7 months (1 month of screening and 6 months wearing device)
Temperature deviation from baseline, to assess sleep quality
change in temperature over time during sleep cycle
Time frame: 7 months (1 month of screening and 6 months wearing device)
Heart rate
Time frame: 7 months (1 month of screening and 6 months wearing device)
Respiratory rate
Time frame: 7 months (1 month of screening and 6 months wearing device)
Calories burned during exercise to assess daily activity
Number of calories burned during each exercise session
Time frame: 7 months (1 month of screening and 6 months wearing device)
Calories burned throughout the day to assess daily activity
total number of calories burned each day
Time frame: 7 months (1 month of screening and 6 months wearing device)
Distance traveled during exercise to assess daily activity
Number of miles traveled during each exercise session
Time frame: 7 months (1 month of screening and 6 months wearing device)
Number of steps to assess daily activity
total number of steps taken each day
Time frame: 7 months (1 month of screening and 6 months wearing device)
Change in PBC-40 fatigue domain score in patients with PBC
The PBC-40 fatigue domain allows a potential value range of 11 to 55 with higher values denoting worse fatigue. A score of \>33 identifies patients with moderate-severe fatigue and a mean change in this score by 5 points after 3 months has been used in other studies to denote clinically meaningful significance.
Time frame: 7 months (1 month screening and 6 months wearing the device)
Change in alkaline phosphatase (ALP) levels
ALP levels (where lower levels reflect better control of PBC disease) will be measured in patients both before and after a second-line therapy (2L) is started.
Time frame: Baseline and following 2L therapy (at doctor's discretion, within 7 month timeline)
Changes in Daily Fatigue Impact Scale.
The Daily Fatigue Impact Scale measures how fatigue interferes with daily functioning. Scores range from 0 to 32, with higher numbers indicating a greater severity of fatigue.
Time frame: 7 months (1 month screening and 6 months wearing the device)
Change in Epworth Sleepiness Scale (ESS) score
The ESS score (the sum of 8 item scores, 0-3) can range from 0 to 24. A result from 11 to 24 indicates excessive (abnormal) daytime sleepiness.
Time frame: 7 months (1 month screening and 6 months wearing the device)