A Comprehensive Self-Management Intervention for individuals with Inflammatory Bowel Disease

项目摘要/摘要 炎症性肠病(IBD)患者会经历严重的症状负担，包括腹部 疼痛、腹胀、疲劳、睡眠障碍、焦虑和抑郁。然而，很少有自我管理的干预措施 是为了减少这一人群中的症状。这项拟议的研究将适应现有的全面自我 管理干预(CSM)在肠易激综合征人群中的有效性 IBD患者群体(CSM-IBD)。该项目的长期培训目标是协助坎普博士 成为一名独立的调查员，拥有一项专注于改善自我和症状的研究计划- 炎症性肠病患者的管理。因此，坎普博士具有增加知识的培训能力 以及在进行随机对照试验、纵向数据管理、 微生物组数据的处理和分析以及领导跨学科团队。具体目标是：1) 确定研究程序(招募、随机、数据和样本)的可行性和可接受性 收集)和CSM-IBD；2)比较CSM-IBD干预和常规护理从基线到 干预后3个月生活质量和日常症状(疲劳、睡眠障碍、心理 以及3)探索症状与社会生态因素(年龄、性别、 种族/民族、饮食)、临床表型(药物、疾病分布)和生物学特征 (微生物组，钙保护素)基线症状和对干预的反应(紧随其后 干预)。预期结果将是初步可行性数据，为未来的R01研究提供参考，该研究将 检查CSM-IBD的疗效。为实现研究目标和培养目标，一门交叉学科 导师团队由症状科学、IBD、心理学、跨学科的专业知识组成 研究、随机对照试验、肠道微生物组、统计和数据管理。该团队与众多的 华盛顿大学现有的资源非常适合将坎普博士转变为一名独立的 调查员。这项研究具有重要意义，因为它将解决有关自我管理的未得到满足的需求 在患有IBD的个体中，不仅有可能显著提高生活质量，而且 改变IBD患者的临床管理模式。

PROJECT SUMMARY/ABSTRACT Individuals with inflammatory bowel disease (IBD) experience a high burden of symptoms including abdominal pain, bloating, fatigue, sleep disturbances, anxiety, and depression. Yet, few self-management interventions exist to reduce symptoms in this population. This proposed study will adapt an existing Comprehensive Self- Management Intervention (CSM) with demonstrated efficacy in an irritable bowel syndrome population into a population of individuals with IBD (CSM-IBD). The long-term training goal of this project is to assist Dr. Kamp in becoming an independent investigator with a program of research focused on improving self- and symptom- management among individuals with IBD. As such, Dr. Kamp has training competencies to increase knowledge and skills in advanced training in conducting randomized controlled trials, longitudinal data management, processing and analysis of microbiome data and leading interdisciplinary teams. The Specific Aims are to: 1) determine the feasibility and acceptability of study procedures (recruitment, randomization, data and sample collection) and the CSM-IBD; 2) compare the CSM-IBD intervention to usual care on changes from baseline to 3 months post-intervention in quality of life and daily symptoms (fatigue, sleep disturbance, psychological distress, and GI symptoms); and 3) explore the association of symptoms with socioecological factors (age, sex, race/ethnicity, diet), clinical phenotype (medications, disease distribution), and biological signatures (microbiome, calprotectin) with symptoms at baseline and response to intervention (immediately post- intervention). The expected outcome will be preliminary feasibility data to inform a future R01 study which will examine the efficacy of the CSM-IBD. To accomplish the research aims and training goals, an interdisciplinary mentorship team has been assembled with expertise in symptom science, IBD, psychology, interdisciplinary research, RCTs, gut microbiome, statistics, and data management. The team, along with the vast array of resources available at the University of Washington, are well-suited to transition Dr. Kamp into an independent investigator. This research is significant because it will address an unmet need regarding self-management among individuals with IBD and has the potential to not only significantly improve the quality of life but also change the clinical management paradigm for individuals with IBD.