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

基本信息

批准号：
10609067
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
项目类别：
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/10609067
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&apos 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 Intestines 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 Recurrence 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 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 treatment as usual trial design young adult

Abdominal Pain Address Adolescent Age Anxiety Behavioral Biological Chronic Chronic Disease Clinical Management Clinical Trials Cognitive Therapy Competence Conduct Clinical Trials Crohn&apos 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 Intestines 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 Recurrence 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 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 treatment as usual trial design young adult

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项目摘要

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.

项目摘要/摘要患有炎症性肠病（IBD）的个体经历了较高的症状负担，包括腹部疼痛，腹胀，疲劳，睡眠障碍，焦虑和抑郁。但是，很少有自我管理干预措施存在以减少该人群的症状。这项拟议的研究将适应现有的全面自我管理干预措施（CSM）在肠易激综合征人群中表现出疗效 IBD（CSM-IBD）的个体人口。该项目的长期培训目标是协助Kamp博士成为一名独立研究者，研究计划的重点是改善自我和症状 - 具有IBD的人的管理。因此，坎普博士具有培训能力以提高知识以及进行随机对照试验，纵向数据管理的高级培训技能，微生物组数据和领先的跨学科团队的处理和分析。具体目的是：1）确定研究程序的可行性和可接受性（募集，随机化，数据和样本收集）和CSM-IBD； 2）将CSM-IBD干预与从基线变为变化的通常护理干预后3个月的生活质量和日常症状（疲劳，睡眠障碍，心理困扰和胃肠道症状）； 3）探索症状与社会生态因素（年龄，性别，种族/种族，饮食），临床表型（药物，疾病分布）和生物学特征（微生物组，钙骨蛋白酶），在基线时出现症状和对干预的反应（立即在干涉）。预期的结果将是初步可行性数据，以告知未来的R01研究检查CSM-IBD的功效。为了完成研究目标和培训目标，跨学科指导团队已在症状科学，IBD，心理学，跨学科方面拥有专业知识研究，RCT，肠道微生物组，统计和数据管理。团队以及一系列华盛顿大学提供的资源非常适合将坎普博士转变为独立研究者。这项研究很重要，因为它将解决有关自我管理的未满足需求在具有IBD的人中，不仅有可能显着改善生活质量更改IBD患者的临床管理范式。