Prospective Evaluation of Flare Detection in IBD With Digital Biomarkers: Bring Your Own Device Study (BYOD)
PROSPECTIVE EVALUATION OF FLARE DETECTION IN IBD WITH DIGITAL BIOMARKERS: BRING YOUR OWN DEVICE STUDY
調査の概要
詳細な説明
IBD, comprising Crohn's disease and ulcerative colitis, is a chronic inflammatory condition of the gastrointestinal tract, with a globally rising prevalence. Current medical care consists of outpatient visits combined with blood and stool tests, radiological examination and endoscopy. The disease is costly to manage, also leading to indirect costs such as reduced work productivity. Telemonitoring platforms, including MyIBDCoach, IBD@home(Luscii) and IBDream, can alleviate these factors by enabling remote cost-effective monitoring of patient's health. However, data collection largely relies on burdensome questionnaires which are susceptible to bias. Emerging technologies such as wearable devices and smartphones enable continuous remote monitoring through digital biomarkers. This Bring Your Own Device (BYOD) study is part of the IBDigital project, which aims to enrich existing monitoring platforms by integrating digital biomarkers.
In this prospective, observational, multicenter cohort study, patients with IBD will be recruited from the outpatient clinics of the participating centers. Data will be collected from participants' personal smartwatches (and smartphones). Following an inclusion period of approximately four months, participants will enter a one-year follow-up period. During follow-up, standard-of-care clinical data will be collected during outpatient visits. In addition, wearable-derived data, including heart rate metrics, sleep parameters, and physical activity measures, will be continuously collected.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：E Godecharle, MD
- 電話番号：+31 43 388 50 65
- メール：eline.godecharle@maastrichtuniversity.nl
研究場所
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's-Hertogenbosch、オランダ
- Jeroen Bosch Hospital
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コンタクト：
- TEH Romkens, MD, PhD
- 電話番号：+3173-5533735
- メール：t.romkens@jbz.nl
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主任研究者：
- TEH Romkens, MD, PhD
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Maastricht、オランダ
- Maastricht UMC+
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コンタクト：
- E Godecharle, MD
- 電話番号：+31 43 388 50 65
- メール：eline.godecharle@maastrichtuniversity.nl
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主任研究者：
- MJ Pierik, Prof. Dr.
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Rotterdam、オランダ
- Franciscus Hospital
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コンタクト：
- R West, MD, PhD
- 電話番号：+31104616895
- メール：r.west@franciscus.nl
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副調査官：
- R West, MD, PhD
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- 18 years or older
- Crohn's Disease or ulcerative colitis
- Having a smartwatch and/or a smartphone
- Apple watch, Samsung Watch, Fitbit, Garmin, Polar (devices will not be made available)
Exclusion Criteria:
- No specific exclusion criteria will be used. Subgroup analysis will be performed for patients with e.g. heart problems or arrhythmia, medication impacting HR (such as beta blockers), pregnancy, thyroid problems, shift work...
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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Patients with IBD
≥18 years or older with Crohn's disease or ulcerative colitis, and having a smartwatch (Apple watch, Samsung Watch, Fitbit, Garmin, Polar (devices will not be made available) ) and/or a smartphone.
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Wearing their own wearable device.
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
時間枠 |
|---|---|
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Prediction of mucosal inflammation (calprotectin≥250 µg/g and/or CRP≥5mg/l with UCEIS≥1 or Mayo≥1 (UC) and SES CD≥3 (CD) on endoscopic/radiological evaluation) using HRV-changes relative to individual baseline.
時間枠：1 year
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1 year
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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Prediction of mucosal inflammation (assessed by laboratory tests and/or imaging in IBD) using changes in physical activity and sleep metrics relative to individual baseline.
時間枠：1 year
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1 year
|
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Identification of a discrepancy between inflammatory flares and symptomatic flares (MIAH-CD>3.6 and MIAH-UC>3.5) regarding HRV.
時間枠：1 year
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1 year
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To study the inter-device variability in mean HRV metrics (including MESOR, acrophase, amplitude, SDNN, RMSSD), PA and sleep parameters, compared to resting state.
時間枠：1 year
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1 year
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Investigation of additional digital phenotypes that can be derived from the available (wearable/clinical) data and how these phenotypes differ across relevant subgroups within the study population.
時間枠：1 year
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1 year
|
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To study the difference in step count measured by smartwatches compared with smartphones.
時間枠：1 year
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1 year
|
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To investigate if changes in HRV, PA and sleep relative to baseline predict clinical/symptomatic remission in IBD.
時間枠：1 year
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1 year
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協力者と研究者
協力者
捜査官
- 主任研究者：MJ Pierik, Prof. Dr.、Maastricht UMC
出版物と役立つリンク
一般刊行物
- Hirten RP, Danieletto M, Sanchez-Mayor M, Whang JK, Lee KW, Landell K, Zweig M, Helmus D, Fuchs TJ, Fayad ZA, Nadkarni GN, Keefer L, Suarez-Farinas M, Sands BE. Physiological Data Collected From Wearable Devices Identify and Predict Inflammatory Bowel Disease Flares. Gastroenterology. 2025 May;168(5):939-951.e5. doi: 10.1053/j.gastro.2024.12.024. Epub 2025 Jan 16.
- Leung W, Case L, Jung J, Yun J. Factors associated with validity of consumer-oriented wearable physical activity trackers: a meta-analysis. J Med Eng Technol. 2021 Apr;45(3):223-236. doi: 10.1080/03091902.2021.1893395. Epub 2021 Mar 22.
- Kaplan GG. The global burden of inflammatory bowel disease: from 2025 to 2045. Nat Rev Gastroenterol Hepatol. 2025 Oct;22(10):708-720. doi: 10.1038/s41575-025-01097-1. Epub 2025 Jul 18.
- Bossuyt P, De Nollin I, De Moor T, Trekels G, Maes I, Dewulf G, Pouillon L. Inflammation Is a Large Dataset of Heartbeats, Groceries, Night Rest, and More. Gastroenterology. 2025 Oct;169(5):1085-1086. doi: 10.1053/j.gastro.2025.05.029. Epub 2025 Jun 25. No abstract available.
- de Jong MJ, Boonen A, van der Meulen-de Jong AE, Romberg-Camps MJ, van Bodegraven AA, Mahmmod N, Markus T, Dijkstra G, Winkens B, van Tubergen A, Masclee A, Jonkers DM, Pierik MJ. Cost-effectiveness of Telemedicine-directed Specialized vs Standard Care for Patients With Inflammatory Bowel Diseases in a Randomized Trial. Clin Gastroenterol Hepatol. 2020 Jul;18(8):1744-1752. doi: 10.1016/j.cgh.2020.04.038. Epub 2020 Apr 23.
- de Jong M, van der Meulen-de Jong A, Romberg-Camps M, Degens J, Becx M, Markus T, Tomlow H, Cilissen M, Ipenburg N, Verwey M, Colautti-Duijsens L, Hameeteman W, Masclee A, Jonkers D, Pierik M. Development and Feasibility Study of a Telemedicine Tool for All Patients with IBD: MyIBDcoach. Inflamm Bowel Dis. 2017 Apr;23(4):485-493. doi: 10.1097/MIB.0000000000001034.
- Hirten RP, Danieletto M, Scheel R, Shervey M, Ji J, Hu L, Sauk J, Chang L, Arnrich B, Bӧttinger E, Dudley J, Keefer L, Sands BE. Longitudinal Autonomic Nervous System Measures Correlate With Stress and Ulcerative Colitis Disease Activity and Predict Flare. Inflamm Bowel Dis. 2021 Oct 18;27(10):1576-1584. doi: 10.1093/ibd/izaa323.
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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