Effectiveness of an e-Health Program to Prevent Exacerbations in the Cystic Fibrosis Population: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Clinical exacerbation
研究概览
简要总结
The goal of this clinical trial is to analyse the impact of a telematic assessment and monitoring protocol in people with cystic fibrosis, in order to identify exacerbations early, thus preventing loss of lung function and maintaining quality of life.
Participants will be assigned to one of 3 study groups:
Control group (CG-1): will receive their usual physiotherapy treatment; Treatment group (TG-2): will receive their usual physiotherapy treatment, plus explanation of the use of the monitoring equipment; Treatment and follow-up group (TGF-3): will receive their usual physiotherapy treatment, plus explanation of the use of the monitoring equipment, plus telematic control of exacerbations with feedback from the physiotherapist.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Participants will be randomly assigned to one of three study groups by the person conducting the intervention.
All participants receive usual physiotherapy treatment, and both intervention groups receive monitoring and follow-up of their clinical situation.
The evaluators are unaware of the assignment at all times.
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed cystic fibrosis
- •Family access to an internet-enabled device
- •Camera and microphone
- •Absence of exacerbations in the last 30 days
排除标准
- •Patients with lung transplant or on the waiting list for lung transplantation
- •Previous eye surgery (3 months)
- •Hemothorax
- •Active infection or inflammatory process
- •Cognitive problems that make it impossible for them to use telematic devices.
研究组 & 干预措施
Control exercise group (CG-1)
Participants will receive their usual physiotherapy treatment.
干预措施: Exercise Group (CG-1) (Behavioral)
Exercise plus monitoring group (TG-2)
Participants will receive their usual physiotherapy treatment, plus explanation of the use of the monitoring equipment.
干预措施: Exercise plus Monitoring Group (TG-2) (Behavioral)
Exercise plus monitoring and follow-up group (TGF-3)
Participants will receive their usual physiotherapy treatment, plus explanation of the use of the monitoring equipment, plus telematic control (via 1:1 real-time videoconferencing) of exacerbations with feedback from the physiotherapist.
干预措施: Exercise plus monitoring and follow-up group (TGF-3) (Behavioral)
结局指标
主要结局
Clinical exacerbation
时间窗: At baseline (T1), at 6 months (T2) and at 12 months(T3).
Presence of an exacerbation. To consider this the Escribano criteria will be followed, for which the presence of at least 3 of the criteria stablished (Clinical, spirometric, radiographic, analytical, and microbiological), collected by interviewing the patient
次要结局
- Oxigenation(At baseline (T1), at 6 months (T2) and at 12 months(T3).)
- Functional capacity(At baseline (T1), at 6 months (T2) and at 12 months(T3).)
- Spirometric function(At baseline (T1), at 6 months (T2) and at 12 months(T3).)
- Dyspnea(At baseline (T1), at 6 months (T2) and at 12 months(T3).)
- Quality of life (QoL)(At baseline (T1) and at 12 months(T3).)
研究者
SARA CORTES AMADOR
Assistant lecturer PhD in Physiotherapy
University of Valencia