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.

该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。它将调查这些能力 生理指标以识别和预测有症状性溃疡性结肠炎（UC）耀斑。它将探索 这些指标通过HRV定向生物反馈干预及其对UC症状的影响的修改性。 候选人：本申请的主要目的是支持罗伯特·赫滕博士的发展 在数字健康和炎症性肠病领域的独立面向患者的研究人员（IBD） 研究。赫滕博士的职业目标是成为一个独立的研究人员和领导者，以利用密集 通过IBD研究中的新型可穿戴技术获得的生理数据。赫滕博士的拟议培训 活动在五个领域：（1）高级统计方法论，（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 由西奈山医院的胃肠病学负责人布鲁斯·桑兹（Bruce Sands）领导 IBD纵向和临床试验研究的专业知识。环境：芒特的伊坎医学院 西奈具有强大的研究传统，并且是NIH资助的前20名医学院。西奈山分区 《胃肠病学》是美国新闻和世界报道中该国排名前十的部门，并且是IBD的领导者 研究和临床护理。西奈山的Hasso Plattner数字健康研究所是国际 具有数据科学，生物医学和数字工程专业知识的研究所。研究：UC是慢性 炎症性疾病以腹泻为特征的有症状性耀斑影响结肠，直肠血液 和腹痛。耀斑经常发生，每年至少30％发生，并且与 发病率和生活质量受损。当前识别和预测耀斑的方法是次优且有限的。如果 可以先前确定耀斑，并可以制定预测的缓解或预防策略。进步 数字和可穿戴技术允许收集连续的无创物理参数 可能与疾病活动有关。因此，我们的具体目的是（1）确定 包括HRV在内的生理指标，在UC中具有症状耀斑，（2）评估预测能力 生理指标，重点是HRV，用于开发UC中症状的耀斑，（3）确定 有症状UC受试者的HRV生物反馈干预的可行性，可接受性和效果大小。到 实现此目的，我们将执行一项纵向队列研究，以招募160名UC的受试者，并遵循 它们持续了12个月或直到爆发，从可穿戴设备（Apple Watch）收集物理索引和 来自智能手机应用程序的调查指标。此外，我们将执行HRV定向生物反馈 干预23名受试者和有症状的耀斑。在此期间获得的一般方法和技能 奖项可以应用于旨在基于这项工作的发现的未来R01赠款。