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临床试验/NCT03860519
NCT03860519已完成不适用

The Use of the Propeller Health Platform to Improve Inhaled Corticosteroid (ICS) Use Among Adults With Uncontrolled Persistent Asthma (Propeller Health)

NorthShore University HealthSystem2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2018年3月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
2
主要终点
Change in Short Acting Bronchodilator Medication use in Group with Propeller Health Platform Digital Technology Turned On vs Group with Propeller Health Platform Digital Technology Turned Off

研究概览

简要总结

This is a behavioral randomized controlled trial of adults with uncontrolled persistent asthma that tests if the Propeller Health sensor, mobile application, and dashboard can improve adherence to ICS.

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
25 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Under the care of a staff asthma physician (i.e. pulmonologist or allergist/immunologist) at NorthShore University HealthSystem (NS)
  • Have an active NorthShore Connect (patient portal) account
  • Persistent uncontrolled asthma in the past 12 months
  • Active prescription for daily ICS medication for asthma

排除标准

  • candidate refusal
  • the presence of other co-morbidities (e.g. severe psychiatric disorder) that could interfere with study participation

结局指标

主要结局

Change in Short Acting Bronchodilator Medication use in Group with Propeller Health Platform Digital Technology Turned On vs Group with Propeller Health Platform Digital Technology Turned Off

时间窗: 3.5 months

Use of the Propeller Health Platform in the treatment group in active mode, compared to the attention control group in silent mode, will demonstrate a 20% change in SABA use and/or minimal clinically important difference (three points) change on the ACT and/or change from ACT score ≤ 19 to ≥20, at 3-months. The 20% change in SABA use = 20 point change (e.g. if a participants uses SABA 40% of days over the 2 week run-in period, and they change SABA use to 20% of days during the final 14 days of the active treatment period, that will equal a 20 point change. If SABA use changes from 40% of days over the 2- week run-in period to 32% of days during the final 14 days of the active treatment period, this will not be considered a 20 point change).

次要结局

  • Participant and clinician satisfaction as assessed by brief post-study survey of Propeller Health Platform Digital Technology(3.5 months)
  • Inhaled Corticosteroid Medication taking Behavior in the Group using Propeller Health Platform Digital Technology Turned On vs Group using Propeller Health Platform Digital Technology Turned Off(3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Giselle Mosnaim

Principal Investigator

NorthShore University HealthSystem

研究点 (2)

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