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临床试验/NCT02839252
NCT02839252撤回不适用

Iggy and the Inhalers: A Pilot Study to Assess the Impact of an Asthma Education Program in School Age Children

Wake Forest University Health Sciences1 个研究点 分布在 1 个国家开始时间: 2016年7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
撤回
试验地点
1
主要终点
Asthma knowledge

研究概览

简要总结

The specific aims of this pilot study are to:

  1. Evaluate the effectiveness of the asthma education intervention on asthma knowledge
  2. Determine whether the asthma education intervention improves child and parent asthma treatment self-efficacy

Our hypothesis is that the asthma education intervention will significantly improve asthma knowledge and asthma self-efficacy at 1 month post-intervention as compared to controls.

详细描述

Potential subjects will be recruited from patients seen at Yacktman General Pediatrics Clinic. Investigators will initially use the clinic's electronic medical record (EMR) to identify potentially eligible subjects who have a regularly scheduled visit during the next 4 months. Once the patient is deemed eligible, they will be marked as "ASTHMA STUDY ELIGIBLE" in a red banner in the EMR. The parent will then be mailed a recruitment letter with parent permission/consent and child assent forms attached for their review. Once a potentially eligible patient shows up for a sick visit or a well visit, they will receive a handout reminding them of the study and asking them to consider participation. After their clinic visit, a designated pediatric resident will obtain parent permission/consent and child assent. Designated residents are those 2nd and 3rd year pediatric residents who have completed appropriate CITI training and financial conflict of interest disclosure, and have been trained by the PI on the study.

Study Endpoints:

The primary endpoint in this study is asthma knowledge at 2 time points: Immediately after the intervention (at the end of the initial clinic visit) and at 1-month post-intervention.

The secondary endpoint is asthma self-efficacy at the same 2 time points.

Procedures Involved:

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
None

入排标准

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

入选标准

  • •Followed in the Yacktman General Pediatrics Clinic at Advocate Children's Hospital - Park Ridge (ACH-PR)
  • •Age 8 - 12 years
  • •Documented diagnosis of asthma (any severity level)
  • •Child and parent are English-speaking
  • •Child is currently taking an asthma medication on either a daily or an as-needed basis
  • •Parent permission/consent and child assent is obtained

排除标准

  • •Child has a diagnosis of another chronic lung or cardiovascular disease
  • •Child was assessed by parents or clinician to have a significant developmental delay, learning, or behavioral disability (e.g., autism spectrum)

研究组 & 干预措施

Intervention Group

Experimental

After the baseline tools have been completed, the child will be given the Iggy Comic Book and trading cards. Parents and their children will then watch a 12-minute Iggy Video. At the completion of the video and prior to going home, the child and parent will complete the same 2 measures on asthma knowledge and self-efficacy. At 1-month after this clinic visit, the parent will be sent an email with a link to a Qualtrics survey that will contain a few supplemental questions to assess use of the intervention and the same 2 measures that the parent and the child completed at the initial visit.

干预措施: Iggy and the Inhalers Asthma Education for Kids (Behavioral)

Control Group

No Intervention

After the baseline tools have been completed, the parent and child will go home. At 1-month after the initial study clinic visit, the parent will be sent an email with a link to a Qualtrics survey that will contain a few supplemental questions to assess use of the intervention and the same 2 measures that the parent and the child completed at the initial visit.

结局指标

主要结局

Asthma knowledge

时间窗: Change in asthma knowledge immediately post-intervention and 1 month after intervention as compared with asthma knowledge prior to the intervention

This will be measured by a 10 question multiple choice survey

次要结局

  • Asthma Self Efficacy(Change in asthma self efficacy scores immediately post-intervention and 1 month after intervention as compared to pre-intervention self-efficacy scores)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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