FollowMuco : Study of Satisfaction of Patients and Care Providers for an Alternate Follow-up With In-hospital Consults and Tele-consult for Patients With Cystic Fibrosis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change in Patients and care providers satisfaction after one year of alternated follow-up (hospital Consults and Tele-consult)
研究概览
简要总结
The pandemic forced us to develop home follow-up for patients with chronical diseases . In the same time, the new era of treatment for cystic fibrosis considerably improves the health of patients with this pathology.
This study aims to assess the satisfaction of patients and care providers for an alternated follow-up between tele-consults and in-hospital consults during one year for patients with cystic fibrosis treated by Kaftrio® since at least one year and stable.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
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 cystic fibrosis
- •Patients treated with Kaftrio® since one year
- •autonomous patients
- •patients without cognitive disorders
- •Patients voluntary for this follow up
- •patients with two tele-communication tools
- •patients with FEV1>50%
- •patients with less of 2 antibiotics cure per year
排除标准
- •all transplanted patients
- •Pregnant patients
- •Particular follow up needed in-hospital consult
- •Persons deprived of their liberty by a judicial or administrative decision
- •Persons subject to psychiatric care
- •Persons admitted to a health or social establishment for purposes other than research
- •Persons not affiliated to a social security scheme or beneficiaries of a similar scheme
结局指标
主要结局
Change in Patients and care providers satisfaction after one year of alternated follow-up (hospital Consults and Tele-consult)
时间窗: Measured at inclusion and after one year of follow up.
Satisfaction of patients and care providers for the follow-up by the Client-Satisfaction-Questionnaire (CSQ-8 for patients and CSQ-3 for care-provider). For the CSQ-8 the minimum value is 8 and the maximum value is 32. There is three levels: Low satisfaction (8-20), medium satisfaction (21-26) and high satisfaction (27-32) .
次要结局
- Comparison between FEV1 measured at the department's respiratory functional exploration center and FEV1 measured with the Spirobank ® during the same in-hospital visit.(At inclusion, 6month and 12 month)
- effect on Patients and care providers quality of life(Measured at inclusion and after one year)
- effect on Patients FEV1 (Forced expiratory volume)(Measured at inclusion and after one year)
- Patients and care providers satisfaction for tele consultation(Measured after tele-consult (at 6 month M+6 and at 12 month M+12))
- effect on Patients antibiotic cure number(Measured at inclusion and after one year)
- effect on patient's weight(Measured at inclusion and after one year)
- Effect on Patients call and mail to CF center(Measured at inclusion and after one year)