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临床试验/NCT01641211
NCT01641211已完成不适用

Using MEDUCATION to Improve Asthma Medication Device Technique

University of North Carolina, Chapel Hill1 个研究点 分布在 1 个国家目标入组 92 人开始时间: 2012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
已完成
入组人数
92
试验地点
1
主要终点
Change in inhaler, turbuhaler, and diskus technique

研究概览

简要总结

This is a feasibility study to determine whether the Expanding Networks for Latinos through Community Engagement (ENLaCE) can be used to recruit Latino children into a randomized, controlled trial (RCT) to improve their asthma medication device technique. Children will be recruited from two pediatric ENLaCE clinics in Greensboro and randomly assigned to watch device technique videos (experimental group; n=50) or a nutrition video (control group, n=50) in Spanish or English after a regularly-scheduled medical visit. Children's device technique will be assessed before and after the visit. Process evaluation data will also be collected. The investigators hypothesize that children in the intervention group will have better device technique post-intervention than the control group.

详细描述

Asthma affects almost 10% of children and is the most common health condition reported by North Carolina public schools. Latino children have higher rates of uncontrolled asthma and more asthma-related emergency department visits than their White counterparts. No studies have evaluated Latino children's asthma device technique; poor technique can compromise medication delivery to the lungs.

The TraCS engagement core has spent the last 18 months developing the Expanding Networks for Latinos through Community Engagement (ENLaCE) network, which is comprised of over 15 organizations in the Greensboro area. The core would now like to conduct a feasibility study to determine whether ENLaCE can be used to recruit Latino children into a randomized, controlled trial (RCT) to improve their asthma medication device technique. This would be the first assessment of whether ENLaCE can be used to recruit patients.

MEDUCATION, an NIH-funded project developed by Polyglot Systems, Inc., has developed asthma device technique videos in Spanish and English. The member groups of ENLaCE believe the MEDUCATION videos are highly relevant for the Greensboro Latino community. Children will be recruited from two pediatric ENLaCE clinics in Greensboro and randomly assigned to watch device technique videos (experimental group; n=50) or a nutrition video (control group, n=50) in Spanish or English after a regularly-scheduled medical visit. Children's device technique will be assessed before and after the visit. Process evaluation data will also be collected.

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
8 Years 至 16 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Children will be eligible if they:
  • •are ages 8 through 16 years,
  • •are able to speak English or Spanish,
  • •can read the assent form,
  • •are present at the visit with an adult caregiver (parent or legal guardian) who can speak English or Spanish and who is at least 18 years of age,
  • •have mild, moderate, or severe persistent asthma, and
  • •are present for an asthma-related visit (either acute or scheduled).

排除标准

  • 未提供

研究组 & 干预措施

Video intervention

Experimental

Group that will watch the Meducation inhaler device technique videos.

干预措施: Meducation device technique video (Behavioral)

Control

Other

This group will watch a nutrition video.

干预措施: Nutrition video (Other)

结局指标

主要结局

Change in inhaler, turbuhaler, and diskus technique

时间窗: Baseline and 1-month follow-up

Children will demonstrate how they use their metered-dose inhalers, turbuhalers, and diskuses using empty devices. The research assistant will record the number of steps performed correctly. Correct use of inhalers, diskuses, and turbuhalers will be measured as continuous variables.

次要结局

  • Child inhaler self-efficacy(Baseline and 1-month follow-up)
  • Asthma Control(Baseline and 1-month follow-up)

研究者

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

Delesha Carpenter, PhD, MSPH

Research Assistant Professor

University of North Carolina, Chapel Hill

研究点 (1)

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