Using Digital Health Technology to Monitor Patients With Primary Biliary Cholangitis (PBC)
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- Это наблюдательное исследование: исследуемое лечение участникам по протоколу не назначают.
- Кому может быть актуально
- Состояния в реестре: Primary Biliary Cholangitis (PBC). Базовые параметры: от 18 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Официальное название
Characterizing Fatigue, Sleep and Activity in Patients Living With Primary Biliary Cholangitis (PBC) Using Digital Health Technology
Обзор
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.
Подробное описание
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.
Первичные конечные точки
- Sleep scores to assess sleep quality will be measured in PBC patients using a wearable device [Срок оценки: 7 months (1 month of screening and 6 months wearing device)]
- SpO2 (saturation of peripheral oxygen) levels to assess sleep quality [Срок оценки: 7 months (1 month of screening and 6 months wearing device)]
- Total time in bed, to assess sleep quality [Срок оценки: 7 months (1 month of screening and 6 months wearing device)]
- Total sleep, to assess sleep quality [Срок оценки: 7 months (1 month of screening and 6 months wearing device)]
- Sleep stage time series (REM), to assess sleep quality [Срок оценки: 7 months (1 month of screening and 6 months wearing device)]
- Sleep stage time series (deep), to assess sleep quality [Срок оценки: 7 months (1 month of screening and 6 months wearing device)]
- Sleep stage time series (light), to assess sleep quality [Срок оценки: 7 months (1 month of screening and 6 months wearing device)]
- Number of "get ups" during sleep, to assess sleep quality [Срок оценки: 7 months (1 month of screening and 6 months wearing device)]
- Temperature deviation from baseline, to assess sleep quality [Срок оценки: 7 months (1 month of screening and 6 months wearing device)]
- Heart rate [Срок оценки: 7 months (1 month of screening and 6 months wearing device)]
Вторичные конечные точки (3)
- Change in alkaline phosphatase (ALP) levels [Срок оценки: Baseline and following 2L therapy (at doctor's discretion, within 7 month timeline)]
- Changes in Daily Fatigue Impact Scale. [Срок оценки: 7 months (1 month screening and 6 months wearing the device)]
- Change in Epworth Sleepiness Scale (ESS) score [Срок оценки: 7 months (1 month screening and 6 months wearing the device)]
Критерии участия
- 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 \[Sp100\]
Критерии исключения
- Uncontrolled chronic inflammatory condition that is likely to contribute to symptoms of poor fatigue and sleep and confound results.
- Active malignancy requiring treatment
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Модель наблюдения
- Только случаи
Центры проведения
США · 1 центр
- Stanford University School of Medicine — Redwood City
Идентификаторы
NCT: NCT07631442 · 83091