Digital Biomarkers of Ulcerative Colitis Flare

溃疡性结肠炎发作的数字生物标志物

• 批准号: 10283677
• 负责人: Robert Hirten
• 金额: $ 16.21万
• 依托单位: ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-01 至 2026-06-30
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10283677
• 关键词: Abdominal Cramps; Abdominal Pain; Affect; American; Apple watch; Area; Autonomic nervous system; Award; Behavior Therapy; Biofeedback; Biological Markers; Blood; Clinical Trials; Clinical Trials Design; Collection; Colon; Country; Data; Data Science; Defecation; Development; Diarrhea; Disease; Disease Outcome; Disease remission; Engineering; Enrollment; Environment; Evaluation; Feces; Flare; Funding; Future; Gastroenterology; Goals; Grant; Hospitals; Impairment; Individual; Individual Differences; Inflammation; Inflammatory Bowel Diseases; Institutes; International; Intervention; Leukocyte L1 Antigen Complex; Link; Longitudinal cohort study; Machine Learning; Maps; Measurement; Measures; Mentorship; Methodology; Methods; Modeling; Monitor; Morbidity - disease rate; Nervous System Physiology; Participant; Patient Recruitments; Patients; Performance; Physicians; Physiologic Monitoring; Physiological; Positioning Attribute; Predisposition; Prevention approach; Prospective cohort; Protocols documentation; Quality of life; Rectum; Reporting; Research; Research Personnel; Resources; Science; Scientist; Silicon Dioxide; Standardization; Statistical Data Interpretation; Surveys; Symptoms; Techniques; Testing; Time; Training; Training Activity; Ulcerative Colitis; United States National Institutes of Health; Work; base; biomarker development; career; career development; chronic inflammatory disease; clinical care; cohort; compliance behavior; digital; digital health; disorder control; experience; heart rate variability; improved; indexing; inflammatory marker; innovation; medical schools; mobile application; model development; news; novel; patient oriented; personalized approach; predictive modeling; prevent; prospective; skills; smartphone Application; symptomatic improvement; symptomatology; wearable device; wearable sensor technology

This project will evaluate longitudinally collected physiological metrics, with a focus on autonomic nervous system function (heart rate variability [HRV]), using wearable devices. It will investigate the ability of these physiological metrics to identify and predict symptomatic ulcerative colitis (UC) flares. It will explore the modifiability of these metrics through a HRV directed biofeedback intervention and its impact on UC symptoms. Candidate: The primary objective of this application is to support the development of Dr. Robert Hirten into an independent patient-oriented researcher in the field of digital health and inflammatory bowel disease (IBD) research. Dr. Hirten’s career goal is to be an independent researcher and leader in leveraging the dense physiological data acquired through novel wearable technologies in IBD research. Dr. Hirten’s proposed training activities are in five areas: (1) Advanced statistical methodology, (2) Digital health, (3) Clinical trial design, (4) Behavioral intervention science, (5) Career development. To achieve these goals Dr. Hirten has assembled a mentorship team led by Dr. Bruce Sands, Chief of Gastroenterology at The Mount Sinai Hospital who has expertise in longitudinal and clinical trial research in IBD. Environment: The Icahn School of Medicine at Mount Sinai has a strong tradition of research and is a top 20 medical school in NIH funding. The Mount Sinai Division of Gastroenterology is a top 10 division in the country by US News and World Report and is a leader in IBD research and clinical care. The Hasso Plattner Institute for Digital Health at Mount Sinai is an international institute with expertise in data science, biomedical and digital engineering. Research: UC is a chronic inflammatory disease affecting the colon with symptomatic flares characterized by diarrhea, blood per rectum and abdominal pain. Flares are frequent, occurring in at least 30% of patients per year, and are associated with morbidity and impaired quality of life. Current methods to identify and predict flare are suboptimal and limited. If flares can be identified earlier and predicted strategies for mitigation or prevent could be instituted. Advances in digital and wearable technology allow for collection of continuous, non-invasive physiological parameters potentially linked with disease activity. Therefore, our specific aims are to (1) To determine the association of physiological metrics, including HRV, with symptomatic flare in UC, (2) To assess the predictive ability of physiological metrics, with a focus on HRV, for the development of symptomatic flare in UC, (3) Determine the feasibility, acceptability, and effect size of a HRV biofeedback intervention in subjects with symptomatic UC. To accomplish this we will perform a longitudinal cohort study enrolling 160 subjects with UC in remission and follow them for 12 months or until flare, collecting physiological indices from a wearable device (Apple Watch) and survey metrics from a smart phone application. In addition, we will perform a HRV directed biofeedback intervention in 23 subjects with UC and symptomatic flare. The general approach and skills acquired during this award can be applied to future R01 grants aimed at building upon the findings from this work.

这个项目将评估纵向收集的生理指标，重点是自主神经 系统功能（心率变异性[HRV]），使用可穿戴设备。它将调查这些 生理指标来识别和预测有症状的溃疡性结肠炎（UC）发作。将探索 通过HRV指导的生物反馈干预及其对UC症状的影响，这些指标的可修改性。 候选人：本申请的主要目标是支持罗伯特·赫滕博士发展成为一名 数字健康和炎症性肠病（IBD）领域的独立患者导向研究员 research. Hirten博士的职业目标是成为一名独立的研究人员和领导者，利用密集的 在IBD研究中通过新型可穿戴技术获得的生理数据。希尔滕博士提出的训练 活动在五个领域：（1）先进的统计方法，（2）数字健康，（3）临床试验设计，（4） 行为干预科学;（5）职业发展。为了实现这些目标，Hirten博士组建了一个 由西奈山医院胃肠科主任布鲁斯桑兹博士领导的导师团队， IBD纵向和临床试验研究的专业知识。地点：The Icahn School of Medicine at Mount 西奈有着悠久的研究传统，是NIH资助的前20名医学院。西奈山分部 胃肠病学是美国新闻和世界报道排名前十的部门，是IBD的领导者 研究和临床护理。位于西奈山的哈索·普拉特纳数字健康研究所是一家国际性的 该研究所拥有数据科学、生物医学和数字工程方面的专业知识。研究：UC是一种慢性 一种影响结肠的炎性疾病，伴有腹泻、直肠出血等症状 和腹痛。发作频繁，每年至少有30%的患者发生，并且与 发病率和生活质量受损。目前的方法来识别和预测耀斑是次优的和有限的。如果 可以更早地识别耀斑，并且可以制定用于减轻或预防的预测策略。进展 数字和可穿戴技术允许连续、非侵入性生理参数的收集 可能与疾病活动有关。因此，我们的具体目标是（1）确定 生理指标，包括心率变异性，与症状发作的UC，（2）评估的预测能力， 生理指标，重点是HRV，用于UC症状发作的发展，（3）确定 HRV生物反馈干预在症状性UC受试者中的可行性、可接受性和效应量。到 为了实现这一点，我们将进行一项纵向队列研究，招募160例缓解期UC受试者，并随访 他们12个月或直到耀斑，收集生理指标从可穿戴设备（苹果手表）， 从智能电话应用程序调查指标。此外，我们将进行心率变异性定向生物反馈 对23例UC和症状性发作受试者进行干预。在此期间获得的一般方法和技能 该奖项可以应用于未来的R 01赠款，旨在建立在这项工作的结果。