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临床试验/NCT04373499
NCT04373499已完成不适用

A Randomized Clinical Trial Evaluating the Effectiveness of Virtual Teach-to-Goal Education vs. Brief Intervention for Children

University of Chicago2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2019年1月16日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
2
主要终点
Proportion of participants with metered dose inhaler (MDI) misuse immediately after V-TTG vs. BI education

研究概览

简要总结

The purpose of this study is to evaluate the effectiveness of two different ways to teach hospitalized children how to use a metered dose inhaler and to follow-up after discharge home from the hospital to determine durability of the education.

详细描述

Asthma is the most common chronic childhood condition and has significant adverse consequences. One in 12 United States children has asthma, resulting in 13.4 million missed school days, 1 million emergency department visits, and 140,000 hospitalizations annually.

A key barrier to self-management of asthma is improper use of respiratory inhalers, which limits disease control. Better inhaler technique is associated with improved asthma outcomes for children. Assessment and education of inhaler technique are recommended at all healthcare encounters, however it is limited in practice because it is resource intensive (both personnel and time) and lacks fidelity. Thus, low-resource interventions that accurately teach inhaler skills are needed to impact pediatric asthma outcomes.

Teach-to-Goal (TTG) is a patient-centered strategy that uses tailored rounds of teaching and assessments to ensure mastery of inhaler technique. Studies show it is effective but resource intensive. A "virtual TTG" (V-TTG) intervention represents an opportunity to deliver inhaler technique education with a high-fidelity, low-resource, and feasible strategy. The module utilizes innovative learning technology with video demonstrations and assessment questions to tailor education to each user; the cycles of assessment and education continues until satisfactory mastery is achieved.

This study evaluates the comparative effectiveness of this high-fidelity, low-resource, and feasible model (V-TTG) versus a standardized brief intervention that mimics usual care to deliver tailored inhaler technique education to children with severe asthma via a randomized clinical trial.

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
Single (Outcomes Assessor)

入排标准

年龄范围
5 Years 至 10 Years(Child)
性别
All
接受健康志愿者

入选标准

  • The child is between the ages of 5-10 years old
  • The child is admitted for an asthma exacerbation, wheezing, or bronchospasm
  • The child is admitted to the Pediatric Hospital Medicine Service at Comer Children's Hospital
  • The child is prescribed albuterol

排除标准

  • The child/parent decline or unable to provide consent/assent, do not speak/read English
  • The child cannot use an inhaler by themselves without a mask
  • The child previously participated in this study
  • The child is currently in the pediatric intensive care unit (PICU)

结局指标

主要结局

Proportion of participants with metered dose inhaler (MDI) misuse immediately after V-TTG vs. BI education

时间窗: Initial study visit / baseline

Evaluate effectiveness of V-TTG as compared to BI as measured by inhaler technique post-intervention. This will provide data on the short-term effectiveness of the interventions. Each patient's inhaler technique will be assessed using validated inhaler checklists by the trained assessor.

次要结局

  • Proportion of participants with metered dose inhaler (MDI) misuse in VTTG vs BI arms at 1 month after education(Follow-up visit at 1 month)
  • Acceptability of V-TTG among children and parents based on Likert-scale questions (1-5)(Initial study visit - after completing V-TTG intervention)
  • Usability of V-TTG among children and parents based on open-ended questions(Initial study visit - after completing V-TTG intervention)
  • Self-efficacy: Questionnaire(Initial study visit - at baseline and immediately after intervention)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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