A Comprehensive Self-Management Intervention for Individuals With Inflammatory Bowel Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Recruitment feasibility
研究概览
简要总结
This study aims to test the feasibility, acceptability, and preliminary efficacy of a comprehensive self-management (CSM) intervention for people with inflammatory bowel disease (IBD). The CSM-IBD intervention is an adaption of the CSM intervention initially developed for individuals with irritable bowel syndrome. The intervention has eight sessions which cover an introduction to IBD, symptom tracking, cognitive behavioral strategies, relaxation, sleep, diet, and pain management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthcare provider diagnosis of inflammatory bowel disease
- •Report current symptoms
- •Able to read and write in English
排除标准
- •Live outside of Washington state
- •Bowel-related surgery within the past month
研究组 & 干预措施
Comprehensive Self-Management
The 8 week intervention is delivered online with a brief weekly check-in with a registered nurse.
干预措施: Comprehensive Self-Management Intervention (Behavioral)
Usual care group
The control group will receive standard care without the comprehensive self-management intervention.
干预措施: Control (Other)
结局指标
主要结局
Recruitment feasibility
时间窗: From screening to enrollment
Percentage comprised of number of participants enrolled divided by the number of participants approached.
Intervention feasibility
时间窗: 3 months
Measured with the Feasibility of Intervention Measure (FIM) in which participants respond to four questions on a 5-point Likert scale from completely disagree (1) to completely agree (5).
Acceptability
时间窗: 6 months
A semi-structured interview guide will be used to assess acceptability of study procedures as well as acceptability and satisfaction with the intervention.
次要结局
- Change in Quality of Life(Baseline, 3 months, 6 months)
- Change in Symptoms(Baseline, 3 months, 6 months)
研究者
Kendra Kamp
Assistant Professor, Biobehavioral Nursing & Health Informatics
University of Washington