Phase 3, Multi-centre, Prospective, Open, Randomized, in Two Parallel Groups Study to Evaluate Efficacy and Tolerance of Patient's Learning in Self-taking of Prescribed Asthma Maintenance Treatments and Provided by a Robot Named JOE.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 213
- 试验地点
- 13
- 主要终点
- Comparison of the mean number of severe asthma exacerbations per patient between the two treatment groups during the 12-month follow-up.
研究概览
简要总结
The main objective of this study is to evaluate efficacy and safety of patient's learning in self-taking of prescribed asthma maintenance treatments and provided by JOE (a new DTX), on the number of severe exacerbations in children with an asthma graded 2, 3, 4 and 5 according to GINA classification.
详细描述
A new device, named JOE, manufactured by Ludocare, is available since 2019 in France. This new device, compact and connected, was designed to be easy to use by children suffering from chronic disease. JOE is a robot designed to improve compliance with asthama maintenance treatments.To confirm efficacy and safety of a patient's learning in self-taking of asthma maintenance treatments provided by JOE, it has been decided to carry out a clinical study in 4 to 11 years old patients and suffering from asthma graded 2, 3, 4 or 5 according to GINA classification. These patients will be recruited by pneumo-pediatricians at hospital or in private practice. The study is a phase 3, multi-center, prospective, open, 2-parallel groups, randomized and controlled study. Each patient will be randomly allocated in one of two studied treatment groups: standard asthma maintenace treatment (group SCT) vs standard asthma maintenance treatment + JOE (a new DTx) (group SCT + JOE). Patients meeting eligible criteria will be included at Day 0 (Visit V0). For each patient the maximal duration of this study will be 12 months. At day 7 a phone call is planned to evaluate patient/parent's motivation and to detect potential technical and/or therapeutic problems. Three visits are planned then after at4 (M4), 8 (M8) and 12 (M12) months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
盲法说明
Data analysis performed on anonymous database.
入排标准
- 年龄范围
- 4 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •4-11years old,
- •able to use JOE
- •persistent uncontrolled asthma, graded 2, 3 , 4 or 5 on GINA classification
- •maintenance treatment since at least 3 months
- •having given their informed written consent
排除标准
- •asthma naïve-treatment child
- •without regular follow-up with the investigator
- •participating to another interventional study, with another disease, other treatments or planned modification of prescribed treatments that could interfere with studied disease
研究组 & 干预措施
Standard + JOE
Standard Maintenance Treatment plus JOE robot
干预措施: JOE (Device)
Standard
Standard maintenance Treatment
结局指标
主要结局
Comparison of the mean number of severe asthma exacerbations per patient between the two treatment groups during the 12-month follow-up.
时间窗: 12 months
Evaluation of patient's learning in self-taking of prescribed treatments and provided by robot companion JOE on number of severe exacerbations needing systemic corticoids. Comparison, between both treatment groups, of number of severe exacerbations over 12 months of follow-up.
次要结局
- Tolerance to the maintenance treatment evaluated by the number and type of adverse events(12 months)
- Effectiveness of the maintenance treatment measured with c-ACT(12 months)
- Global costs estimation evaluated by price(12 months)