Assessing the Use of Digital Therapeutic in Adult Asthma Patients: A Remote Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 104
- 试验地点
- 1
- 主要终点
- Change in rescue medication usage
研究概览
简要总结
This is a prospective, remote observational study of adults with persistent asthma who are managed on inhaled corticosteroids.
详细描述
The study consists of one interventional group and all 104 subjects will be included in this group. All subjects will be provided with the HeroTracker package, which includes:
- HeroTracker sensor that counts dosage and monitors real-time medication adherence
- BreatheSmart mobile application that sends subjects real-time alerts and allows patients respond to questionnaires / surveys.
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
- •Ability to provide written informed consent
- •Male and female adults (aged ≥ 18 years)
- •Diagnosis of asthma for at least 6 months
- •ICS (inhaled corticosteroid) use for at least 3 months
- •Use of a pressurized metered dose inhaler (pMDI) compatible with the HeroTracker
- •Possess a compatible smartphone (iOS 8.0 or higher and Android 4.3 or higher)
排除标准
- •Currently pregnant or planning to become pregnant during the study period
- •Primary language other than English (BreatheSmart mobile app is currently available only in English)
研究组 & 干预措施
BreatheSmart
104 subjects will be provided with the BreatheSmart platform, which consists of:
- HeroTracker sensor that monitors real-time asthma medication adherence
- BreatheSmart mobile application that provides patients with real-time alerts, environmental information (weather, pollution, etc.), and the ability to complete questionnaires / surveys.
干预措施: BreatheSmart (Device)
结局指标
主要结局
Change in rescue medication usage
时间窗: 3 months
Determine change in rescue medication usage in subjects the BreatheSmart system from baseline to 3 months.
Change in asthma control
时间窗: 3 months
Determine change in the asthma control test (ACT), a validated asthma test, in subjects using the BreatheSmart system from baseline to 3 months.
次要结局
- Change in controller medication adherence(3 months)
- Acceptability of BreatheSmart system(3 months)
