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临床试验/NCT03103880
NCT03103880已完成不适用

Assessing the Use of Digital Therapeutic in Adult Asthma Patients: A Remote Observational Study

CoheroHealth1 个研究点 分布在 1 个国家目标入组 104 人开始时间: 2017年4月21日最近更新:
适应症
干预措施

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:

  1. HeroTracker sensor that counts dosage and monitors real-time medication adherence
  2. 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

Experimental

104 subjects will be provided with the BreatheSmart platform, which consists of:

  1. HeroTracker sensor that monitors real-time asthma medication adherence
  2. 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)

研究者

发起方
CoheroHealth
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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