Assessment of the Social Cost of Crohn's Disease (COsto Sociale Della Malattia di CrOhn - COSMO): Economic and Quality of Life Aspects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 245
- 主要终点
- EuroQoL (Quality of Life)-5 Dimensions (EQ-5D) Scores in Participants With Crohn's Disease
研究概览
简要总结
This observational study will evaluate the social cost and quality of life of participants who have had Crohn's Disease for at least 6 months and have active disease despite drug therapy. Participants are followed for a total of 18 months.
详细描述
Participants for this study will be enrolled from 25 gastroenterology sites, even spread across Italy. Each center will enroll between 10 and 40 participants each.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •participant must:
- •be between 18 and 70 years of age,
- •have active Crohn's disease (CD) with CDAI score >= 150 (as per amended protocol) in spite of drug therapy, or active fistulizing disease,
- •be diagnosed with CD for at least 6 months,
- •sign the informed consent,
- •be capable of understanding the study and replying to the questionnaires.
排除标准
- •Participants who are unreliable in filling out questionnaires,
- •Participants with diseases which may interfere with the cost's of CD or its complications,
- •Participants who are participating in a clinical trial
结局指标
主要结局
EuroQoL (Quality of Life)-5 Dimensions (EQ-5D) Scores in Participants With Crohn's Disease
时间窗: Baseline, 6, 12, and 18 months
EQ-5D was calculated for the pharmacoeconomics analysis to evaluate quality of life (QoL) in participants in the active phase with Crohn's Disease and had a CDAI score \>= 150. EQ-5D is a participant answered questionnaire scoring 5 dimensions - mobility, self-care, usual activities, pain/discomfort and anxiety/depression. The EQ-5D total score ranges from 0 (worst health state) to 1 (perfect health state) and 1 reflects the best outcome.
Cost of Illness in Participants With Crohn's Disease
时间窗: Baseline, 6, 12, and 18 months
Direct health care costs, non health care costs and costs for productivity loss were calculated by observation period in Crohn's Disease participants (in active phase) with a CDAI score \>= 150. Direct health care costs refer to the resources used to prevent and treat a disease. Indirect costs include expenses for a participant's (or their caregiver's) transport, home assistance or home nursing assistance. Costs for productivity loss include the participant's (or their caregiver's) productivity loss or time loss.
次要结局
未报告次要终点