Respreeza® Self-administration and Learning Program (AmAREtTI Study- Auto-Administration de Respreeza® et Programme d'apprenTIssage)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- CSL Behring
- 入组人数
- 15
- 试验地点
- 11
- 主要终点
- Percentage of patients who switch to self-administration without the presence of a nurse
研究概览
简要总结
According to the Respreeza® Summary of Product Characteristics, the initial infusions must be administered under the supervision of a health professional experienced in the treatment of alpha-1 antitrypsin deficiency, although subsequent infusions may be administered at home by the person responsible for care or by the patient.
Clinical data on self-administration of Respreeza® are however limited and the grounds for self-administration are left to the assessment of the attending physician, who needs to ensure that appropriate training is delivered.
In this context, CSL Behring would like to run a clinical study in order to assess the effectiveness of a home self-administration learning program in terms of switching to self-administration, and the long term maintenance of this administration.
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
- •Adult patients (age ≥18 years old).
- •Patients suffering from AATD treated by Respreeza® through a peripheral vein at home for at least 3 month (consecutives or not). The 3-month period of treatment with Respreeza® does not necessarily correspond to the 3 months prior to inclusion.
- •Patient accompanied by a third person at home
- •Patients deemed to be suitable by the investigator for self-administration.
- •Patients with a life expectancy of over 3 years.
- •Patients who have been informed verbally and in writing via the information leaflet and who have signed the informed consent form.
排除标准
- •In order to reflect the reality of everyday practice, no non-inclusion criteria are intended except for patient refusal to take part in the study.
结局指标
主要结局
Percentage of patients who switch to self-administration without the presence of a nurse
时间窗: Up to 12 months
Percentage of patients who switch to self-administration without the presence of a nurse at the end of the learning program
时间窗: Up to 8 weeks
A patient will be permitted to switch to self-administration without the presence of a nurse if the following conditions are met: * Three consecutive successful self-administrations by the patient in the presence of the nurse but without assistance during the learning phase. * Validation of the learning grid The percentage is based on number of patient switching to self-administration and remains in self-administration 12 months after
次要结局
- Tolerance and safety(Up to 12 months)
- The time frame for autonomy(Up to 12 months)
- Percentage of patients who switch to self-administration without the presence of a nurse(Up to 8 weeks)
- Evolution of patients Quality of Life with Saint George's Respiratory Questionnaire (SGRQ)(Up to 12 months)
- Patient characteristics(At inclusion)
- Degree of autonomy(At inclusion and 12 months after self-administration)
- Patients satisfaction for treatment administration by a nurse and for self-administration(Up to 12 months)
- Satisfaction about learning program(Up to 8 weeks)
- Compliance/Observance(Up to 8 weeks)
- Determining factors for switch to self-administration(Up to 8 weeks)