Development and Validation of a Questionnaire to Measure the Impact of Short Bowel Syndrome (SBS) and Its Treatments on Patients' Lives
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Scale calibration of the new developped questionnaire
研究概览
简要总结
Today, patients express a very strong need to take into account the consequences of their disease and its treatments in their therapeutic follow-up. It is therefore essential to better understand the needs, expectations and values of patients with SBS in order to better understand the impact of the disease on their lives, and thus improve the conditions for medical, social, psychological and technical care. The clinical expertise of health professionals and meetings with patient associations demonstrate the major gap between the parameters taken into account by physician to evaluate the evolution of the SBS and the day-to-day experience of the disease perceived by the patient.
The objective of the ARTEMIS-GC study is to develop and validate an instrument to measure the impact of SBS and its treatments on daily life from the perspective of patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Other
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
- •Patients with SBS defined by a hail length remaining in post-duodenal < 2 meters
- •Patients with intestinal insufficiency, i.e. chronic malabsorption requiring energetic and/or hydro-electrolytic intravenous support for more than 6 months
- •Patients with a period of at least 6 months after the establishment of the SBS
- •Patients who has already had a return home after the establishment of the SBS for a period of at least 3 months
排除标准
- •Patients with intestinal insufficiency but with a cause other than SBS
- •Lack of understanding of the study
- •Not speaking French
结局指标
主要结局
Scale calibration of the new developped questionnaire
时间窗: about 30 minutes
Calibration measure
Structure of the new developped questionnaire
时间窗: about 30 minutes
Structure identification
Convergence proprieties of the new developped questionnaire
时间窗: about 30 minutes
Convergence evaluation
Reproducibility of the new developped questionnaire
时间窗: Up to 8 days
Test of reproducibility
次要结局
未报告次要终点