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临床试验/NCT03304067
NCT03304067已完成不适用

Digital Health Tool for Parental Management of Childhood Asthma -- Impact on Asthma Control Test Scores

Evidation Health2 个研究点 分布在 1 个国家目标入组 262 人开始时间: 2017年10月3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
262
试验地点
2
主要终点
Change in ACT/C-ACT scores

研究概览

简要总结

The "Digital Health Tool for Parental Management of Childhood Asthma -- Impact on Asthma Control Test Scores" Study is a 16 week, prospective, intent-to-treat, 2-arm randomized controlled trial that aims to evaluate the impact of the Tueo Health program on asthma control as indicated by change in baseline and study end (week 16) score on the Childhood Asthma Control Test score (ages 6- under 12 years) and the Asthma Control Test (ages 12-17 years) in children with uncontrolled asthma as the primary study objective.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
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

入选标准

  • Parent has a child who is > 6 and < 17.5 years old
  • Parent reports child has a diagnosis of asthma
  • Child takes daily asthma controller medication
  • Child has used rescue inhaler (e.g.albuterol, ProAir, etc) or nebulizer at least 2 times per week in the past 4 weeks
  • Child sleeps on a toddler, single, or double bed by themselves
  • Child will live in the same home for the majority of the next 16 weeks
  • Parent is > 18 years old

排除标准

  • Child's asthma has been controlled over the past 4 weeks
  • Child has any of the following conditions: sleep apnea, congenital heart disease, cardiac arrhythmias, or any other heart abnormalities, neurologic conditions including seizures, cerebral palsy, muscular dystrophy, genetic conditions or developmental disorders, autism, other major medical condition
  • Child is currently pregnant
  • Child was born premature (earlier than 36 weeks)
  • Parent is not fluent in English
  • No in-home WiFi
  • Parent does not use an Android phone as their primary phone
  • In a household with an existing enrolled participant in the study, even for a different child (e.g. only one child in a household may have questions reported back to the researchers by their parent)
  • Lives in Hawaii or Alaska

研究组 & 干预措施

Intervention

Experimental

干预措施: Tueo Program (Behavioral)

Control

No Intervention

结局指标

主要结局

Change in ACT/C-ACT scores

时间窗: Baseline and Week 16

Change in ACT/C-ACT scores from baseline to study end

次要结局

未报告次要终点

研究者

发起方
Evidation Health
申办方类型
Industry
责任方
Sponsor

研究点 (2)

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