Use of a Connected Companion in Children With Cystic Fibrosis - COMPANION-CF
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- Evaluate therapeutic adherence of children with cystic fibrosis aged 3 to 11 years with help of a connected medical companion
研究概览
简要总结
The study will be conducted over a 6 months period. For the first three months, the child will be accompagned with a connected companion. After this period, the companion will be removed for three months in oder to prove this companion could improve treatment adherence for children suffering from cytolisis fibrosis.
This study will be conducted at the University Hospital Center of Rennes and Hospital Center of Saint-Brieuc.
详细描述
In developed countries, chronic diseases with long-term therapy adherence is about 50%, according to the WHO report, and the adherence rate for regular intake of preventive therapies decreases to 28%.
For cystic fibrosis, rates are not much higher. Optimistic articles report an average compliance rate of 60%. Other articles report a rate of 50% which varies according to the age of the patient, the intake treatment complexity and burdensome drug treatment (physiotherapy achieves the lowest adherence with 38%), the disease understanding and the interest of treatment persuasion. Low adherence can also be the result of incorrect use of administration devices, for example for inhaled treatments. Technical errors are very frequent and affect around 30% of patients.
Families with children suffering from cystic fibrosis need daily support. Health professionals need to relay their recommendations at home. This is why new and funny tools dedicated to children with chronic illnesses are needed.
This trial will study the impact of connected companion named LEO® created by Ludocare company.
Study will be conducted as :
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child volunteer from 3 to 11 years old
- •Affected by cystic fibrosis
- •With a prescription containing at least two medications twice a day
- •Affiliation to the national health insurance
- •Child and holder of the exercise of parental authority understands and speaks French
- •The person exercising parental authority must have reached the age of majority.
- •Collection of the written consent of one of the holders of the exercise of parental authority
排除标准
- •Non-voluntary child, under 3 years of age or over 12 years of age
- •Family reluctant to technology
- •Family without smartphone and/or wifi connection
- •Failure to obtain the written consent of one of the holders of the exercise of parental authority
- •Child involved in research involving the human person
结局指标
主要结局
Evaluate therapeutic adherence of children with cystic fibrosis aged 3 to 11 years with help of a connected medical companion
时间窗: Through study completion, up to 6 months
The main evaluation criterion will be the overall compliance of the cohort in percentage terms. These data from connected companion will be refined for each type of treatment: pancreatic extracts, inhaled treatments, CFTR modulator, antibiotics, vitamins, laxative treatment, antacids, bile acids, food supplements, physiotherapy. For each treatment, the data "take" or "not take" will be treated by device and provide for statistical analysis in percentage. Each percentage will be grouped in global percentage will be therapeutic adherence all over study.
次要结局
- Evaluate any negative impacts associated with the use of the robot(4 to 6 months)
- Study of the reasons of low compliance or difficulties in taking the treatments(4 to 6 months)
- Assess child's autonomy regarding his treatments(4 to 6 months)
- Assess the intake treatments quality(4 to 6 months)
- Assess the psycho-social impact of treatment and illness(4 to 6 months)