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: 10471362
• 负责人: Robert Hirten
• 金额: $ 16.26万
• 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/10471362
• 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.

该项目将评估纵向收集的生理指标，重点关注自主神经 使用可穿戴设备的系统功能（心率变异性 [HRV]）。它将调查这些人的能力 用于识别和预测有症状的溃疡性结肠炎 (UC) 发作的生理指标。它将探索 通过 HRV 引导的生物反馈干预来修改这些指标及其对 UC 症状的影响。 候选人：本申请的主要目标是支持 Robert Hirten 博士发展成为一名 数字健康和炎症性肠病 (IBD) 领域以患者为中心的独立研究员 研究。 Hirten 博士的职业目标是成为一名独立研究员和利用密集数据的领导者。 IBD 研究中通过新型可穿戴技术获取的生理数据。 Hirten 博士建议的培训 活动涉及五个领域：(1) 先进统计方法，(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，希尔滕博士组建了一个 由西奈山医院胃肠病科主任 Bruce Sands 博士领导的导师团队 IBD 纵向和临床试验研究方面的专业知识。环境： 蒙特伊坎医学院 西奈半岛拥有悠久的研究传统，是 NIH 资助排名前 20 的医学院。西奈山分区 胃肠病学被《美国新闻与世界报道》评为美国前 10 名科室，并且是 IBD 领域的领导者 研究和临床护理。西奈山哈索普拉特纳数字健康研究所是一家国际 拥有数据科学、生物医学和数字工程专业知识的研究所。研究：UC是一种慢性病 影响结肠的炎症性疾病，其症状为腹泻、直肠出血 和腹痛。耀斑很频繁，每年至少有 30% 的患者发生，并且与 发病率和生活质量受损。目前识别和预测耀斑的方法并不理想且有限。如果 可以更早地识别耀斑，并可以制定缓解或预防的预测策略。进展 数字和可穿戴技术可以连续、非侵入性地收集生理参数 可能与疾病活动有关。因此，我们的具体目标是（1）确定关联 生理指标，包括 HRV，在 UC 中出现症状发作，(2) 评估预测能力 UC 症状发作发展的生理指标，重点是 HRV，(3) 确定 HRV 生物反馈干预对有症状 UC 受试者的可行性、可接受性和效果大小。到 为了实现这一目标，我们将进行一项纵向队列研究，招募 160 名 UC 缓解期受试者并进行随访 持续 12 个月或直到发作，从可穿戴设备（Apple Watch）收集生理指标，并 来自智能手机应用程序的调查指标。此外，我们将进行 HRV 定向生物反馈 对 23 名患有 UC 和症状发作的受试者进行干预。在此期间获得的一般方法和技能 该奖项可应用于未来的 R01 赠款，旨在以这项工作的发现为基础。