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临床试验/NCT02787174
NCT02787174已完成不适用

A Computer-Based ED Intervention to Improve Pediatric Asthma Medicine Adherence

Rhode Island Hospital1 个研究点 分布在 1 个国家目标入组 109 人开始时间: 2016年2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
109
试验地点
1
主要终点
Asthma controller medication adherence

研究概览

简要总结

Asthma is common in children and impacts their health. There are effective medications for improving asthma, but some families have difficulty using medicines on a regular basis. This study in the emergency department will improve medicine use for children 2-12 years-old with asthma by developing content for a customized, tablet-based electronic intervention. A clinical trial will then be used to compare asthma outcomes for this intervention with routine asthma care.

详细描述

The investigators have used focus groups to get ideas from parents of children with asthma to best design the intervention. This has helped us create the questions that are being used in the intervention, and make the computer program appealing and acceptable to parents of children with asthma.

The investigators will study the success of the intervention for children who receive it compared to children who obtain routine emergency department care. Participants who receive the intervention will complete a series of questions on a tablet computer. Questions will guide creation of individualized education and advice to improve medication use for each participant. The intervention will also allow for customized communication with each child's primary care provider. The investigators will include educational boosters at 2 and 4 weeks after the intervention delivered as chosen by the participant (email / text / RSS / mail). Children in the routine asthma care arm will not receive the intervention, and instead will receive routine discharge instructions by the emergency room doctors.

The investigators will compare the success of the intervention group to routine emergency department care by using a device (DOSER CT) that measures daily administered doses of medicine. Data from the DOSER CT will be collected monthly at home visits for three months. The investigators will also measure health care use and quality-of-life for each child using a survey at these home visits. The investigators believe that the intervention will improve doses of medicine given, reduce unnecessary health care use, and improve children's quality of life.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Investigator)

入排标准

年龄范围
2 Years 至 12 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Asthma diagnosis by physician or parent report
  • •Ages 2-12
  • •Prescribed an inhaled corticosteroid asthma controller medicine

排除标准

  • •Parent does not speak English
  • •Child is prescribed inhaled corticosteroid seasonally
  • •Patient is on a combination inhaled corticosteroid controller asthma med

研究组 & 干预措施

Control

No Intervention

Participants will receive routine clinical treatment care.

Intervention

Experimental

Participants will receive interactive tailored asthma medication adherence education on an iPad.

干预措施: Asthma Medication Adherence Education (Other)

结局指标

主要结局

Asthma controller medication adherence

时间窗: 12 weeks

Percentage adherent days defined as at least half of prescribed doses taken as measured by Doser CT

次要结局

  • Sustained Asthma controller medication adherence(3 months)
  • Quality-of-Life (QOL)(6 months)
  • Unscheduled healthcare use (self-report survey and chart review)(6 months)

研究者

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

Aris Garro

Physician

Rhode Island Hospital

研究点 (1)

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