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临床试验/NCT04896645
NCT04896645已完成不适用

Albuterol Integrated Adherence Monitoring in Children With Asthma

Children's Hospital Los Angeles2 个研究点 分布在 1 个国家目标入组 21 人开始时间: 2021年6月1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
21
试验地点
2
主要终点
Asthma Adherence

研究概览

简要总结

The investigators propose to evaluate whether an integrated electronic adherence monitoring albuterol rescue inhaler can improve proper use in a mostly minority and inner-city population of children treated for asthma at the Children's Hospital of Los Angeles

详细描述

This study is designed to (1) determine whether an integrated EAM albuterol rescue inhaler can increase proper use (2) determine if the monitoring capabilities of the device (flow rate, warnings) and/or increased proper use from having the device correlate with better outcomes. The investigators will also have patients perform at-home gamified spirometry (Aluna ©) to (3) determine if at-home spirometry can predict albuterol use or change outcomes.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
8 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Patients 8 to <19 years of age with a diagnosis of asthma as ICD-9 code 493 or ICD-10 code J45 seen in the allergy clinic at CHLA who have an albuterol rescue inhaler already prescribed and access to a personal smartphone will be eligible for recruitment.

排除标准

  • Patients unable to use device, unable to use albuterol (i.e. must use levalbuterol) or Age < 4 (ProAir® Digihaler only approved for Subjects 4 years and older). Patients with other chronic lung disease besides asthma or other significant comorbidities that could affect lung function/asthma (e.g. significant heart defects, immunodeficiency, cystic fibrosis, etc).

结局指标

主要结局

Asthma Adherence

时间窗: 3 months

4-item Morisky Medication Adherence Scale (MMAS-4)

Albuterol Use

时间窗: 3 months

Questionnaires created by investigators addressing when and how often albuterol is used for symptoms, illness, etc.

Asthma Outcomes

时间窗: 3 months

Severity by NHLBI EPR3 Guidelines

次要结局

  • Spirometry(3 months)
  • Asthma Quality of Life(3 months)
  • Lung Function(3 months)

研究者

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

Neema Izadi

Assistant Professor

Children's Hospital Los Angeles

研究点 (2)

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