National Mobile Asthma Management System-E Project
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 870
- 试验地点
- 1
- 主要终点
- Proportion of good adherence at the 6th month
研究概览
简要总结
Bronchial asthma is a heterogeneous disease characterized by chronic airway inflammation, which is a common and frequently occurring disease in the world, and has resulted in a sustained increase of social and economic burden. However, several studies suggest, lots of asthma patients did not get their asthma controlled. The investigators study showed that in China only 28.7% of asthma patients achieve asthma controlled during 2007-2008. In recent years, application softwares of mobile-phones for asthma have gradually increased, studies suggested that application of these application softwares can make treatment more standard, reduce asthma attacks, help patients to control their asthma, improve adherence and these application softwares also show many other advantages. This study is a prospective, multi center, randomized, controlled study, aims to evaluate the efficacy of application softwares in asthma patients, provide a new tool to asthma management.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
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
- •1.18 years of age or older, having been resided in the same city during the study; 2.A history of at least 3 months of diagnosed asthma based on the criteria established by GINA 2016; need to be on medication containing ICS or ICS/LABA 3.Asthma out patients with ACT scores﹤20 and MARS - A mean score < 4.5 ; 4.Owning and Being able to use smart phone that the corresponding software can be successfully installed; 5.Subjects who are willing to participate in the study and sign the informed consent.
排除标准
- •Unable to communicate properly because of visual impairment, hearing impairment and language barrier, or with mental illness or psychological problems;
- •Have a history of tracheal intubation or mechanical ventilation as a result of acute asthma attack;
- •Have respiratory tract infection within the prior 4 weeks; history of thoracic surgery; with comorbidities such as other/structural lung diseases (COPD, bronchiectasis, lung cancer, et al); heart disease; kidney or autoimmunity disease; or other conditions that could potentially effect asthma control or asthma disease status by investigator's medical opinion.
- •Women with pregnancy, or planned pregnancy within one year.
研究组 & 干预措施
mobile management
use mobile management to improve asthma control
干预措施: Mobile Asthma Management System (Behavioral)
Traditional management
use Traditional management to improve asthma control
干预措施: traditional Asthma Management System (Behavioral)
结局指标
主要结局
Proportion of good adherence at the 6th month
时间窗: 6 months
patients will fill out the MARS-A questionnaire on their own，and the MARS-A Scores will be calculated to show their adherence of medication. Good adherence: MARS-A score\>=4.5
次要结局
- Emergency visits(1 year)
- Hospitalization(1 year)
- Asthma Control Test（ACT）(1 year)
- Proportion of good adherence(1 year)
- Forced expiratory volume in one second（FEV1）(1 year)
- Forced vital capacity(FVC)(1 year)
- Asthma Quality of Life Questionnaire(AQLQ)(1 year)
- Fractional exhaled nitric oxide(FeNO)(1year)
- Peak expiratory flow(PEF)(1 year)
- Correct answer rate of the given asthma awareness questions(1 year)
研究者
Jiangtao Lin
Chief physician
China-Japan Friendship Hospital