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

针对炎症性肠病患者的综合自我管理干预措施

• 批准号: 10447396
• 负责人: Kendra Joy Kamp
• 金额: $ 14.34万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-04-12 至 2025-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10447396
• 关键词: Abdominal Pain; Address; Adolescent; Age; Anxiety; Behavioral; Biological; Chronic; Chronic Disease; Clinical Management; Clinical Trials; Cognitive Therapy; Competence; Conduct Clinical Trials; Crohn' s disease; Data; Data Collection; Diagnosis; Diarrhea; Diet; Discipline of Nursing; Disease; Distress; Dropout; Ethnic Origin; Fatigue; Foundations; Future; Gases; Goals; Health; Healthcare Systems; Individual; Inflammatory Bowel Diseases; Interdisciplinary Study; Intervention; Irritable Bowel Syndrome; Knowledge; Leadership; Learning; Leukocyte L1 Antigen Complex; Literature; Medical; Mental Depression; Mentorship; Monitor; Muscle Cramp; Nurses; Outcome; Participant; Patients; Pharmaceutical Preparations; Physical Function; Pilot Projects; Population; Precision Health; Procedures; Psychology; Psychosocial Factor; Quality of life; Race; Randomized; Randomized Controlled Trials; Relaxation; Reporting; Research; Research Personnel; Resources; Sampling; Science; Self Management; Sleep disturbances; Social Functioning; Solid; Subgroup; Symptoms; Training; Ulcerative Colitis; Universities; Washington; Work; acceptability and feasibility; anxiety symptoms; associated symptom; career; career development; chronic inflammatory disease; clinical phenotype; cost; data management; efficacy evaluation; efficacy testing; experience; gastrointestinal; gastrointestinal symptom; gut microbiome; health care service utilization; holistic approach; improved; innovation; intervention delivery; intervention participants; microbiome; microbiome analysis; pilot test; post intervention; programs; psychological distress; psychosocial; recruit; reduce symptoms; response; sample collection; sex; skills; sleep quality; statistics; symptom management; symptom science; symptomatic improvement; treatment as usual; trial design; young adult

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.

项目总结/摘要 患有炎症性肠病（IBD）的个体经历了包括腹部疾病在内的症状的高负担。 疼痛、腹胀、疲劳、睡眠障碍、焦虑和抑郁。然而，很少有自我管理干预措施 以减少这一人群的症状。这项拟议的研究将适应现有的综合自我- 在肠易激综合征人群中证实有效的管理干预（CSM）， IBD患者群体（CSM-IBD）。本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，其研究项目专注于改善自我和症状， 管理IBD患者。因此，坎普博士有培训能力，以增加知识 以及进行随机对照试验，纵向数据管理， 微生物组数据的处理和分析以及领先的跨学科团队。具体目标是：1） 确定研究程序（招募、随机化、数据和样本）的可行性和可接受性 收集）和CSM-IBD; 2）比较CSM-IBD干预与常规护理从基线至 干预后3个月的生活质量和日常症状（疲劳、睡眠障碍、心理 痛苦和GI症状）;和3）探索症状与社会生态因素（年龄，性别， 人种/种族、饮食）、临床表型（药物、疾病分布）和生物学特征 （微生物组，钙卫蛋白）与基线症状和对干预的反应（治疗后立即） 干预）。预期结果将是初步的可行性数据，为未来的R 01研究提供信息， 检查CSM-IBD的功效。为了实现研究目标和培养目标， 导师团队已经组装了症状科学，IBD，心理学，跨学科 研究、RCT、肠道微生物组、统计学和数据管理。这个团队，沿着 华盛顿大学的现有资源，非常适合将坎普博士转变为独立的 调查员这项研究很重要，因为它将解决有关自我管理的未满足的需求 在IBD患者中，不仅有可能显着改善生活质量， 改变IBD患者的临床管理模式。