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| Name | Class |
|---|---|
| Gilead Sciences | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with Primary Biliary Cholangitis (PBC) and an abnormal alkaline phosphatase (ALP) | Patients with an ALP >1.67x ULN will be preferentially enrolled, but all patients with an elevated ALP can be considered. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | 7 months (1 month of screening and 6 months wearing device) |
| SpO2 (saturation of peripheral oxygen) levels to assess sleep quality | 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 | 7 months (1 month of screening and 6 months wearing device) |
| Total sleep, to assess sleep quality | Number of hours per day spent asleep | 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 | 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 | 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 | 7 months (1 month of screening and 6 months wearing device) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline and following 2L therapy (at doctor's discretion, within 7 month timeline) |
| Changes in Daily Fatigue Impact Scale. |
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Inclusion Criteria:
PBC diagnosis based on meeting 2 of 3 criteria:
Ability to provide informed consent
Ability to complete digital questionnaires
Elevated alkaline phosphatase
Abbreviations:
alkaline phosphatase [ALP] gamma-glutamyl-transferase [GGT] antimitochondrial antibody [AMA] Primary Biliary Cholangitis [PBC] Plasmacytoid dendritic cells [PDC] glycoprotein 210 [Gp210] Scleroderma 100 [Sp100]
Exclusion Criteria:
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30 adult patients, diagnosed with PBC and with abnormal alkaline phosphatase (ALP)
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| Name | Affiliation | Role |
|---|---|---|
| Aparna Goel, MD | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Redwood City | California | 94063 | United States |
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| ID | Term |
|---|---|
| D008105 | Liver Cirrhosis, Biliary |
| D008107 | Liver Diseases |
| D011537 | Pruritus |
| D005221 | Fatigue |
| D005222 | Mental Fatigue |
| ID | Term |
|---|---|
| D002780 | Cholestasis, Intrahepatic |
| D002779 | Cholestasis |
| D001649 | Bile Duct Diseases |
| D001660 | Biliary Tract Diseases |
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| Number of "get ups" during sleep, to assess sleep quality | Number of times "getting up" during the night while trying to sleep | 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 | 7 months (1 month of screening and 6 months wearing device) |
| Heart rate | 7 months (1 month of screening and 6 months wearing device) |
| Respiratory rate | 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 | 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 | 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 | 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 | 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. | 7 months (1 month screening and 6 months wearing the device) |
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. |
| 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. | 7 months (1 month screening and 6 months wearing the device) |
| D004066 |
| Digestive System Diseases |
| D008103 | Liver Cirrhosis |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012877 | Skin Manifestations |
| D012816 | Signs and Symptoms |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |