A UK Observational Study to Evaluate the Impact of Care4Today® IBD, a Smart System to Facilitate the Management of Crohn's Disease by Patients and Health Care Providers
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Crohn's Disease Related Secondary Health Related Utilization (HRU) in the 6 Months Pre-Activation of Care4Today® Inflammatory Bowel Disease (C4T IBD) Application (Pre-Index)
研究概览
简要总结
The purpose of this study is to describe the Crohn's Disease (CD)-related secondary healthcare resource utilisation of patients in the 6 months pre- and 12 months post-activation of Care4Today® inflammatory bowel disease (C4T IBD) alongside standard of care (SOC) in the management of CD.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Participants with moderate to severe Crohn's disease (CD), diagnosed at least 6 months prior to index date, as documented by the treating healthcare professional (HCP)
- •Participants with at least 6 months of continuous care in the study centre prior to index date
- •Participants who have agreed to install Care4Today® inflammatory bowel disease (C4T IBD) on their iOS or android smartphone as part of their management of CD
- •Participants providing informed written consent to participate in the study from the date of activation (including installation and linkage to HCP web interface) of the C4T IBD app on his/her smartphone
排除标准
- •Participants with presence of ileorectal or ileal pouch-anal anastomosis documented in their medical records
- •Participants in remission for over 2 years as documented in their medical records
- •Participants participating in an interventional clinical trial
- •Participants participating in an observational study where the protocol interferes with the C4T study in the opinion of the principal investigator at each site
- •Participants with insufficient command of English to interact effectively with C4T IBD and complete the study questionnaires in the opinion of the principal investigator at each site
- •Participants unable or unwilling to provide their informed written consent to participate in the study
结局指标
主要结局
Crohn's Disease Related Secondary Health Related Utilization (HRU) in the 6 Months Pre-Activation of Care4Today® Inflammatory Bowel Disease (C4T IBD) Application (Pre-Index)
时间窗: 6 months pre-index of C4T IBD application
The number of gastroenterology health care provider (HCP) contacts per participant in the 6 months pre-index will be reported. Index is the activation date of C4T IBD application in participant's smartphone.
Crohn's Disease Related Secondary HRU in the 12 Months Post-Activation of C4T IBD Application (post-index)
时间窗: Up to 12 months post index of C4T IBD application
The number of gastroenterology HCP contacts per participant in the 12 months post-index will be reported. The 12 months post-index period will be split into two time periods: 0-6 months post-index and 6-12 months post-index. The 0-6 and 6-12 month post-index periods will be described separately.
次要结局
- Crohn's Disease (CD)-Related Primary Healthcare Resource Utilization(6 months pre- and 12-months post-index)
- Number of Participants with Characteristics Including Duration of Disease, Current Treatments and Previous Treatments(At screening (during 6 months pre-index))
- Disease Activity of Participants Measured Using the Harvey-Bradshaw Index (HBI) or Modified HBI(6 months pre- and 12 months post-index)
- Disease Activity of Participants Measured Using Markers of Systemic Inflammation(6 months pre- and 12 months post-index)
- Disease Progression of Participants Measured Using the Fatigue Severity Scale (FSS)(Up to 12 months post-index)
- Impact of C4T IBD on Participant's Level of Engagement with Their Disease Measured Using the Patient Activation Measure (PAM)(Up to 12 months post-index)
- Disease Progression of Participants Measured Using Number of Bowel Movements(Up to 12 months post-index)
- Disease Progression of Participants Measured by Level of Abdominal Pain(Up to 12 months post-index)
- Impact of C4T IBD on Health Related Quality of Life (HRQoL, General and Inflammatory Bowel Disease [IBD] Specific) and Productivity(Up to 12 months post-index)
- Patient- and HCP-Reported Satisfaction(Up to 12 months post-index)