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

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

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.

Study Overview

• Status: Completed
• Conditions: Asthma in Children
• Intervention / Treatment: Behavioral: Virtual Teach to Goal; Behavioral: Brief Instruction

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. 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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60637
      • University of Chicago Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 17 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Families will be included in the study if:

  1. The child is between the ages of 6-17 years old
  2. The child has a diagnosis of asthma, wheezing, or bronchospasm
  3. The child has been or is seen in general pediatrics, pediatric pulmonary, or pediatric allergy clinic at the University of Chicago Medical Center
  4. The child is taking medication for asthma, wheezing, or bronchospasm (either a controller medication or a quick-relief medication)
  5. 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:

  1. The child/parent decline or unable to provide consent/assent
  2. The child/parent does not speak/read English
  3. The child cannot use an inhaler by themselves without a mask
  4. The child previously participated in this study
  5. The family does not have access to wifi and/or data that supports virtual video-based platforms (if study done virtually)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual Teach-to-Goal (V-TTG); They will be randomized to receive education via a virtual learning module.	Behavioral: Virtual Teach to Goal; Participants will complete inhaler education on a tablet device.
Active Comparator: standardized brief intervention; Intervention that mimics usual care to deliver inhaler technique education.	Behavioral: Brief Instruction; Participants will be read out loud instruction on how to use their inhaler.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants with effective inhaler use (>75% steps correct) post-intervention with V-TTG versus BI	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	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of inhaler technique steps correct pre- and post-V-TTG education	Evaluation of inhaler technique before and after education using validated checklist	At baseline
Number of inhaler technique steps correct at 1 month	Evaluation of inhaler technique 1-month after education/baseline session	1-month after enrollment
Score of Asthma Control Survey	Assessed using validated survey measure	12-months
Score of Asthma Impact	Assessed using validated survey measure	12-months
Score of Caregiver Quality of Life	Assessed using validated survey measure	12-months
Score of Child Asthma Management Self-Efficacy	Assessed using validated survey measure	12-months
Number of healthcare encounters self-reported and EHR-recorded since baseline	Healthcare utilization measured via program-specific questionnaire delivered to parent and child as well as manual review of medical records	12-months

Collaborators and Investigators

• Sponsor: University of Chicago
• Collaborators: American Thoracic Society
• Investigators: Principal Investigator: Anna Volerman, MD, University of Chicago

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2020
• Primary Completion (Actual): November 5, 2021
• Study Completion (Actual): November 5, 2021

Study Registration Dates

• First Submitted: April 16, 2020
• First Submitted That Met QC Criteria: July 13, 2020
• First Posted (Actual): July 14, 2020

Study Record Updates

• Last Update Posted (Actual): February 18, 2022
• Last Update Submitted That Met QC Criteria: February 17, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Immune System Diseases; Lung Diseases; Hypersensitivity, Immediate; Bronchial Diseases; Lung Diseases, Obstructive; Respiratory Hypersensitivity; Hypersensitivity; Asthma
• Other Study ID Numbers: 192091

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No