Using Digital Health Technology to Monitor Patients With Primary Biliary Cholangitis (PBC)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Primary Biliary Cholangitis (PBC). Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Characterizing Fatigue, Sleep and Activity in Patients Living With Primary Biliary Cholangitis (PBC) Using Digital Health Technology
Overview
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.
Detailed description
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.
Primary outcome measures
- Sleep scores to assess sleep quality will be measured in PBC patients using a wearable device [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 [Time frame: 7 months (1 month of screening and 6 months wearing device)]
- Total sleep, to assess sleep quality [Time frame: 7 months (1 month of screening and 6 months wearing device)]
- Sleep stage time series (REM), to assess sleep quality [Time frame: 7 months (1 month of screening and 6 months wearing device)]
- Sleep stage time series (deep), to assess sleep quality [Time frame: 7 months (1 month of screening and 6 months wearing device)]
- Sleep stage time series (light), to assess sleep quality [Time frame: 7 months (1 month of screening and 6 months wearing device)]
- Number of "get ups" during sleep, to assess sleep quality [Time frame: 7 months (1 month of screening and 6 months wearing device)]
- Temperature deviation from baseline, to assess sleep quality [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)]
Secondary outcome measures (3)
- Change in alkaline phosphatase (ALP) levels [Time frame: Baseline and following 2L therapy (at doctor's discretion, within 7 month timeline)]
- Changes in Daily Fatigue Impact Scale. [Time frame: 7 months (1 month screening and 6 months wearing the device)]
- Change in Epworth Sleepiness Scale (ESS) score [Time frame: 7 months (1 month screening and 6 months wearing the device)]
Eligibility criteria
- Inclusion Criteria:
- PBC diagnosis based on meeting 2 of 3 criteria:
- Cholestatic liver biochemistry at disease outset (defined as elevation in the serum ALP level or GGT).
- Associated autoantibody (AMA or PBC-associated antinuclear antibody by immune fluorescence or anti-PDC, anti-Gp210, or anti-Sp100) at a titer of greater than or equal to 1:40.
- Diagnostic or compatible liver biopsy.
- 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
- Uncontrolled chronic inflammatory condition that is likely to contribute to symptoms of poor fatigue and sleep and confound results.
- Active malignancy requiring treatment
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
United States · 1 center
- Stanford University School of Medicine — Redwood City
Identifiers
NCT: NCT07631442 · 83091