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临床试验/NCT03930381
NCT03930381已完成不适用

Adapting and Expanding the Algorithmic Software Tool to Help Manage Asthma (ASTHMAXcel) for Youth With Asthma

Montefiore Medical Center1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2018年5月1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
入组人数
80
试验地点
1
主要终点
Change from Baseline Asthma Control to 3 Month Asthma Control

研究概览

简要总结

This project seeks to test and refine an adapted/expanded version of a previously created ASTHMAXcel app.

详细描述

The study will test the adapted app on participants ages 15-21 (recruited from outpatient primary and specialty care sites at Montefiore) with asthma, for a period of 4 and a half months, and will conduct formative and summative evaluation of the application's functionality and usability. The investigators will also be collecting process and clinical outcomes.

研究设计

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

入排标准

年龄范围
15 Years 至 21 Years(Child, Adult)
性别
All
接受健康志愿者
否

入选标准

  • •English-speaking individuals between 15-21
  • •Persistent asthma (diagnosis made by a healthcare provider)
  • •On a daily controller medication
  • •Able to give informed consent
  • •Smartphone (iOS or Android) access

排除标准

  • •Use of oral corticosteroids in the 2 weeks prior to the baseline visit
  • •Pregnancy
  • •Severe psychiatric or cognitive problems that would prohibit an individual from understanding and completing the protocol
  • •Patients that previously received the ASTHMA-Educator application

研究组 & 干预措施

Intervention Arm

Experimental

This group will download the ASTHMAXcel application and use it for the duration of the study

干预措施: ASTHMAXcel App (Other)

Usual Care Arm

No Intervention

This group will just receive normal provider care

结局指标

主要结局

Change from Baseline Asthma Control to 3 Month Asthma Control

时间窗: Post-Refinement Baseline, 4 Months

Asthma symptom burden as measured by the Asthma Control Test Score Scale: 5 (min = worse); 25 (max = better outcome)

Change from Baseline Asthma Control to 3 Month Asthma Control

时间窗: Post-Refinement Baseline, 3 Months

Asthma symptom burden as measured by the Asthma Control Test Score Scale: 5 (min = worse); 25 (max = better outcome)

次要结局

  • Medication Adherence(Post-Refinement Baseline, 3 Month)
  • Asthma Symptom Perception(Week 2, Week 4 , Week 6 (Pre and Post Refinement))
  • Patient Satisfaction(Post-Refinement Baseline, 3 Month)
  • Emergency Department Visits(Post-Refinement Baseline, 3 Month)
  • Asthma Quality of Life(Post-Refinement Baseline, 3 Month)
  • Patient Interface Satisfaction(Post-Refinement Baseline, 3 Month)
  • Patient Usage(Baseline, 3 Month)
  • Health Literacy(Post-Refinement Baseline)
  • Asthma Knowledge(Post-Refinement Baseline, 3 Month)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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