Effect of a Mobile App on Improving Asthma Control in Adolescents and Adults With Persistent Asthma: A Pilot Randomized Multicentre, Superiority Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Asthma control (CARAT)
研究概览
简要总结
mINSPIRERS_RCT aims to assess the magnitude of the effect of a mobile app for improving asthma control in adolescents and adults with persistent asthma, followed at primary and secondary care in Portugal.
详细描述
INSPIRERS_RCT is a pilot randomized, multicenter superiority clinical trial regarding the effect of a mobile app together with usual care (experimental group) in comparison to usual care alone (control group) in adolescents and adults with persistent asthma. The study includes two face-to-face visits (initial visit and at 3 months), and 3 telephone interviews (1 week, 1 month and 4 months), implemented in 32 primary (General Practice) and secondary care centers (Allergy, Pediatrics, Pulmonology) in Portugal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 64 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 13 and 17 years (adolescents) or and between 18 and 64 years (adults);
- •Previous medical diagnosis of persistent asthma;
- •Uncontrolled or partially controlled asthma according to Global Initiative for Asthma (GINA) criteria;
- •Active prescription of inhaled control medication for asthma (all treatments will be accepted. There will be no change in the prescribed therapeutic regimen directly or indirectly related to participation in this study);
- •Ability to use mobile app and a access (availability and use) to Android mobile devices with internet access;
- •Do not currently use any mobile application for asthma management.
排除标准
- •Patients diagnosed with chronic respiratory disease other than asthma or, diagnosed with another significant chronic disease, with possible interference with the objectives and/or evaluations of the study.
- •Patients that participated in previous feasibility studies with InspirerMundi app will be excluded.
研究组 & 干预措施
InspirerMundi app plus usual care
Patients, in addition to usual care, will be invited to use the InspirerMundi app for 4 months to support adherence to preventive inhaled medication and their asthma self-management.
干预措施: InspirerMundi app (Device)
InspirerMundi app plus usual care
Patients, in addition to usual care, will be invited to use the InspirerMundi app for 4 months to support adherence to preventive inhaled medication and their asthma self-management.
干预措施: Usual care (Other)
Usual care
Patients in the control group will maintain usual care during the study.
干预措施: Usual care (Other)
结局指标
主要结局
Asthma control (CARAT)
时间窗: Baseline, 3 months
Change from baseline in the proportion of patients with controlled asthma as assessed with the CARAT-Control of Allergic Rhinitis and Asthma Test at 3 months
次要结局
- Asthma control (GINA)(Baseline, 3 months)
- Change in Absenteeism in the last 3 months(Baseline, 3 months)
- Change in Treatment adherence (Test of the Adherence to Inhalers)(Baseline, 3 months)
- Change in EuroQol-5 Dimensions (EQ-5D)(Baseline, 3 months)
- Change in Number of asthma exacerbations in last 3 months(Baseline, 3 months)
- Change in Beliefs about Medicines(Baseline, 3 months)
- Change in Satisfaction with inhaler(1 week, 4 months)