Skip to main content
OpenTrials
Completed

NCT Number: NCT04470180

Virtual Teach to Goal vs. Brief Intervention Inhaler Study-outpatient

This study aims to evaluate the comparative effectiveness of a high-fidelity, low-resource, and feasible model versus a standardized brief intervention that mimics usual care to deliver tailored inhaler technique education to children with asthma via a randomized clinical trial. We have already conducted a trial of V-TTG among elementary school-aged children hospitalized in the inpatient setting and we now aim to test this tool in the outpatient clinic setting among a broader pediatric patient population.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

6 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Chicago Medicine

Chicago, Illinois, 60637, United States

About this study

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. Urban, minority, and underserved youth are disproportionally affected. On Chicago's South Side, one-in-five children have an asthma diagnosis; over half visit an urgent care or emergency department (55%), miss school (51.2%), or require parents to miss work annually due to asthma (56.1%).

Effective self-management is crucial to optimize asthma care and improve outcomes. A key barrier to self-management is the 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. Our team developed a V-TTG intervention for adults with demonstrated efficacy. It remains unknown whether this interactive and adaptive module will be feasible and effective in the pediatric population due to varied developmental levels and parental involvement in care.

Virtual Teach-to-Goal (V-TTG) holds the potential to improve inhaler technique in children; however, because learning theory indicates children and adults learn differently, the same learning module cannot be utilized. We have already constructed V-TTG for children with feedback from children with asthma, parents, and healthcare professionals. The learning module is tailored for age by using developmentally and age-appropriate vocabulary, concepts, format, and pacing.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Families will be included in the study if:
  • The child is between the ages of 6-17 years old
  • The child has a diagnosis of asthma, wheezing, or bronchospasm
  • The child has been or is seen in general pediatrics, pediatric pulmonary, or pediatric allergy clinic at the University of Chicago Medical Center
  • The child is taking medication for asthma, wheezing, or bronchospasm (either a controller medication or a quick-relief medication)
  • The family has acess to wifi and/or data that supports virtual video-based platforms (if study is done virtually)

Exclusion criteria

  • Families will be excluded from the study if:
  • The child/parent decline or unable to provide consent/assent
  • The child/parent does not speak/read English
  • The child cannot use an inhaler by themselves without a mask
  • The child previously participated in this study
  • The family does not have access to wifi and/or data that supports virtual video-based platforms (if study done virtually)

Treatment and study plan

Virtual Teach to Goal

Behavioral

Participants will complete inhaler education on a tablet device.

Brief Instruction

Behavioral

Participants will be read out loud instruction on how to use their inhaler.

Primary outcomes

  1. Proportion of participants with effective inhaler use (>75% steps correct) post-intervention with V-TTG versus BI

    Time frame: 12 months

    Inhaler technique will be assessed based on a validated published checklist, which was developed and validated by Dr. Press15 and utilized in my preliminary research with children (see Preliminary Studies). For this primary outcome, we will account for the pre-intervention technique to account for any differences in baseline of the two groups

Secondary outcomes

  1. Number of inhaler technique steps correct pre- and post-V-TTG education

    Time frame: At baseline

    Evaluation of inhaler technique before and after education using validated checklist

  2. Number of inhaler technique steps correct at 1 month

    Time frame: 1-month after enrollment

    Evaluation of inhaler technique 1-month after education/baseline session

  3. Score of Asthma Control Survey

    Time frame: 12-months

    Assessed using validated survey measure

  4. Score of Asthma Impact

    Time frame: 12-months

    Assessed using validated survey measure

  5. Score of Caregiver Quality of Life

    Time frame: 12-months

    Assessed using validated survey measure

  6. Score of Child Asthma Management Self-Efficacy

    Time frame: 12-months

    Assessed using validated survey measure

  7. Number of healthcare encounters self-reported and EHR-recorded since baseline

    Time frame: 12-months

    Healthcare utilization measured via program-specific questionnaire delivered to parent and child as well as manual review of medical records

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Collaborators

  • American Thoracic Society

Registry information

Official study title

An RCT of Virtual Teach-to-Goal Versus Brief Instruction for Children With Asthma in Clinics

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Jul 14, 2020
Registry last updated
Feb 18, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.