Personalized Risk Estimation for Crohn's Disease (PRE-Crohn's): Implementation and Feasibility
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Total enrollment (n) at 1.5 years and retention rate (%) at study conclusion
研究概览
简要总结
The aim of this study is to develop and assess the feasibility and effect of a web-based, personalized risk-estimation for Crohn's disease (PRE-Crohn's) tool on behaviors and biomarkers associated with risk for Crohn's disease in unaffected first-degree relatives of patients with inflammatory bowel disease. We hypothesize that personalized risk disclosure via the PRE-Crohn's educational tool is both feasible and successful in modifying behaviors associated with Crohn's disease risk and normalizing pre-clinical disease biomarkers when compared to standard Crohn's disease education. Broadly, completion of this project will also help elucidate the role of lifestyle and dietary factors in pre-clinical Crohn's disease development in high-risk individuals, and provide novel insight into potential strategies for disease prevention in this population.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Ability to give informed consent
- •Ability and willingness to comply with all patient visits and study-related procedures
- •Ability to understand and complete study questionnaires
- •Must have at least one first-degree relative with inflammatory bowel disease (Crohn's disease, ulcerative colitis, or indeterminate colitis/IBD unclassified)
- •Individuals greater than 14 years of age
排除标准
- •Inability to provide informed consent
- •Inability to comply with all patient visits and study-related procedures
- •Inability to understand or complete study questionnaires
- •Patients with existing diagnoses of inflammatory bowel disease (ulcerative colitis, Crohn's disease, or indeterminate colitis/IBD unclassified)
- •Evidence of clinical signs or symptoms of inflammatory bowel disease, identified by a modified version of the Harvey-Bradshaw Index for CD activity
研究组 & 干预措施
Intervention Arm
Personalized Risk Estimation for Crohn's Disease (PRE-Crohn's) tool
干预措施: Personalized Risk Estimation for Crohn's Disease (PRE-Crohn's) tool (Behavioral)
Comparator arm
Standard Crohn's Disease Education
干预措施: Standard Crohn's Disease Education (Behavioral)
结局指标
主要结局
Total enrollment (n) at 1.5 years and retention rate (%) at study conclusion
时间窗: 1.5 years and time of study completion
The total enrollment at 1.5 years and the retention rate recorded at the conclusion of the study will be measured based on completion of the 6-month survey.
次要结局
- Motivation to change smoking behavior(8 weeks and 6 months)
- Motivation to change diet(8 weeks and 6 months)
- Motivation to change physical activity(8 weeks and 6 months)
- Change in physical activity(8 weeks and 6 months)
- Change in fruit intake(8 weeks and 6 months)
- Change in vegetable intake(8 weeks and 6 months)
- Change in processed meat intake(8 weeks and 6 months)
- Change in fiber intake(8 weeks and 6 months)
- Change in added sugar intake(8 weeks and 6 months)
- Change in smoking behaviors(8 weeks and 6 months)
- Change in C-reactive protein (CRP; mg/L)(8 weeks and 6 months)
- Change in fecal calprotectin (mcg/g)(8 weeks and 6 months)
- Change in seropositivity for antimicrobial biomarkers(8 weeks and 6 months)
研究者
Emily R. Lopes, MD, MPH
Principal Investigator, Instructor of Medicine, Harvard Medical School
Massachusetts General Hospital