What Treatment Adherence for Home Parenteral Nutrition in Patients With Chronic Intestinal Failure ?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 126
- 试验地点
- 6
- 主要终点
- Difference in the volume of parenteral nutrition
研究概览
简要总结
This observational, cross-sectionnal, multicentric study evaluates treatment adherence of home parenteral nutrition in patients with chronic intestinal failure.
详细描述
Chronic intestinal failure (CIF) is a chronic disease and its main treatment is home parenteral nutrition. This disease is defined by a small bowel dysfunction preventing absorption of nutrients and water inputs. A " normal " oral diet is then insufficient, and must be supplied by an " artificial " parenteral nutrition. This treatment is administered at home, by a central veinous catheter, with varying volumes and frequencies.
The quality of life of patients treated by home parenteral nutrition is significatively altered .
The constraints linked to this treatment may make it difficult to follow. The patients can be lead to ask their doctor for a relief or a modification of this treatment during office visits, to improve their quality of life.
Poor treatment adherence concerns 25% of patients with chronic disease . It has never been assessed in France in CIF.
The goal of this study is to evaluate the treatment adherence for home parenteral nutrition in two of its components: negotiation during office visits, and compliance at home.
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
- •Age 18 or older.
- •Diagnosis of CIF (insufficiency of intestinal absorptive, motor or vascular functions that require parenteral nutrition).
- •Home parenteral nutrition treatment for at least 6 months.
- •With home parenteral nutrition treatment stable for at least 3 months.
- •Agreeing to participate in research protocol.
排除标准
- •Any condition that does not let a telephone interview (example : deafness, severe neurocognitive impairment).
结局指标
主要结局
Difference in the volume of parenteral nutrition
时间窗: Inclusion visit, 8 weeks
A 10% (or more) difference between " ideal " and " final " prescriptions (one week's assessment of volume difference in mL) And/or During telephone survey, highlighting a 10% (or more) difference in nutrition received, compared to what is indicated on the prescription (assessment done on the difference in volume in mL over a week).
次要结局
- Patient's compliance(Inclusion visit)
- Anxiety and depression symptom(Inclusion visit)
- Patient's trust(Inclusion visit)