Developing a Self-Management Intervention to Improve Health Outcomes for Patients With Inflammatory Bowel Disease: Part 3 Pilot Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Participant recruitment rate
研究概览
简要总结
This research is studying whether changing an individual's behaviors may have an impact as a treatment or outcome for inflammatory bowel disease. This research will increase the understanding of the role of a self-management program in improving health and health-related quality of life for patients with inflammatory bowel disease.
The study team hypothesizes:
- the study will achieve a recruitment rate of 10 participants every 3 months
- 70% participant retention at 24 weeks
- 70% outcome data collection
- 70% intervention completion
- high acceptability
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
It will be difficult to effectively blind the participants and research staff to the intervention, but the study team will avoid unnecessary inquiry about allocation or hypothesized outcomes with participants and clinicians.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Inflammatory Bowel Disease (IBD) based on conventional clinical, endoscopic, and histopathological criteria, clinically active IBD
- •Impaired health-related quality of life
- •Clinically active IBD will be indicated by both a modified Harvey Bradshaw Index (HBI) ≥5 for Crohn's disease (CD) or a Simple Clinical Colitis Activity Index (SCCAI) ≥3 for ulcerative colitis (UC)
- •Fecal calprotectin > 250 microgram (ug/g)
- •Impaired IBD-specific health-related quality of life will be defined as a Short IBD Questionnaire score ≤ 60
排除标准
- •Unable to speak and read English
- •Unable to access the internet regularly by phone or web as this will impair participants ability to engage with the intervention components
- •Have an ileostomy, colostomy, ileoanal pouch, or ileorectal anastomoses
- •Are planned for imminent surgery
- •Have short bowel syndrome
- •Uncontrolled medical or psychiatric disease
研究组 & 干预措施
Standard care
Care as usual
干预措施: Standard Care (Behavioral)
Standard Care plus digital self-management program
24-week digital self-management program
干预措施: Standard Care (Behavioral)
Standard Care plus digital self-management program
24-week digital self-management program
干预措施: Digital self-management program (Behavioral)
结局指标
主要结局
Participant recruitment rate
时间窗: 2 years (during the recruitment period)
Feasibility will be defined by participant recruitment rate (the proportion of the proposed sample size who enroll to participate in the study over time). The study team hypothesize that the team will achieve a recruitment rate of 10 participants every 3 months.
The proportion of enrolled participants that complete the study without dropout
时间窗: 24 weeks
Feasibility will be defined by retention (the proportion enrolled participants who complete the study without dropout). The study team hypothesize that 70% participant retention at 24 weeks,
The proportion of study assessments completed by the participant
时间窗: 24 weeks
Feasibility willed be defined by the outcome assessment completion (the proportion of study assessments completed by participant). The study team hypothesize that 70% outcome data collection.
Qualitative interviews - self-management program group
时间窗: 24 weeks
Protocol acceptability will be determined based on post-intervention qualitative data. Discussion with participants will be facilitated by questions focusing on feedback about intervention characteristics, including content and functionality (e.g., usability, timing, frequency) and evaluate helpfulness, likes and dislikes, barriers and facilitators to use, and suggestions for improvement.
次要结局
- Theoretical Framework of Acceptability (TFA)(24 weeks)
- Treatment Acceptability Adherence Scale (TAAS)(24 weeks)
- Qualitative interviews - self-management program group(24 weeks)
研究者
Shirley Cohen-Mekelburg
Assistant Professor
University of Michigan