Observational Study to Define Patient Preferences Toward the Attributes of Treatment Used for Inflammatory Bowel Disease, Including Efficacy Profile, Safety Profile, Frequency and Route of Administration, in Europe
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 686
- 试验地点
- 1
- 主要终点
- Partworth Utilities for Participants With CD and UC
研究概览
简要总结
The purpose of this survey is to describe Crohn's disease (CD) participants' as well as ulcerative colitis (UC) participants' preferences towards the attributes of treatment with advanced therapies for IBD, including safety and efficacy profiles, frequency and route of administration (RoA) in a real-world setting.
详细描述
This is a descriptive, observational, cross-sectional survey of participants with IBD. The survey will look into the preferences of participants towards the attributes of treatment with advanced therapies for IBD based on DCE (experimentally designed survey), including safety and efficacy profiles, frequency and RoA in a real-world setting, in European participants living with CD or UC.
The survey will involve data collection in a real-world setting via an online self-reported questionnaire hosted on the Carenity platform, an international participant community.
The survey will enroll approximately 600 participants. Participants will be enrolled in two observational cohorts:
- CD Participants
- UC Participants
This multi-center trial will be conducted in France, the United Kingdom, Italy, Spain, Belgium, Switzerland, the Netherlands.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
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
- •Self-reported suffering from CD or UC.
排除标准
- •Have never been ever treated with prescription medications for CD or UC.
- •Should be included in the study only once.
- •Data collected from participants who subsequently withdraw their consent will not be included in or will be deleted from the database.
结局指标
主要结局
Partworth Utilities for Participants With CD and UC
时间窗: 20 minutes after one time-survey start
Partworth utilities (attribute importance scores and level values) will be evaluated separately for UC and CD in discrete choice experiment's (DCE) conditional logit (CL) models.DCEs:an attribute-based measure of benefit. CL model analyses DCEs.All DCE attributes will be included in CL models.For CD:remission after one year,occurrence of serious adverse effects or events,mild adverse effects or events, long-term remission on maintenance treatment and administration of medication.For UC: corticosteroid-free remission,healing of intestinal mucosa of bowel after one year,long-term remission on continuous treatment and administration of medication.All attributes will be coded as categorical variables;attribute levels will be dummy-coded,whereby omitted categories will be coded:0,omitted category for each attribute will be reference level of partworth utility.Negative partworth utility indicates less desired levels and positive partworth utility indicates more desired levels of attributes.
次要结局
- Mean Evaluation of Preference Rating For Oral Tablet or Pill(20 minutes after one time-survey start)
- Partworth Utilities for Subgroup Participants With CD and UC(20 minutes after one time-survey start)
- Number of Participants Categorized by Characteristics Based on Interaction With the Administration Attribute(20 minutes after one time-survey start)
- Percentage of CD and UC Participants who Switched Their Treatment due to Pain(20 minutes after one time-survey start)
- Mean Evaluation of Preference Rating for Subcutaneous (SC) Injection With Needle and Without Needle(20 minutes after one time-survey start)
- Assessment of Latent Classes and Respective Partworth Utilities(20 minutes after one time-survey start)
- Percentage of CD and UC Participants who Switched Their Treatment(20 minutes after one time-survey start)
- Mean Evaluation of Preference Rating for Intravenous Infusion(20 minutes after one time-survey start)