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Clinical Trials/NCT04373499
NCT04373499
Completed
N/A

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

University of Chicago1 site in 1 country70 target enrollmentJanuary 16, 2019

Overview

Phase
N/A
Intervention
Not specified
Conditions
Asthma
Sponsor
University of Chicago
Enrollment
70
Locations
1
Primary Endpoint
Proportion of participants with metered dose inhaler (MDI) misuse immediately after V-TTG vs. BI education
Status
Completed
Last Updated
5 years ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
January 16, 2019
End Date
December 31, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • 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

Exclusion Criteria

  • 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)

Outcomes

Primary Outcomes

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

Time Frame: 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.

Secondary Outcomes

  • 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)

Study Sites (1)

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