Virtual Teach-to-Goal Education vs. Brief Education for Children (V-TTG vs BI)

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

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.

Study Overview

• Status: Completed
• Conditions: Asthma; Shortness of Breath; Bronchospasm
• Intervention / Treatment: Behavioral: Virtual Teach to Goal; Behavioral: Brief Intervention

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.

• Study Type: Interventional
• Enrollment (Actual): 70
• 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: 5 years to 10 years (Child)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual Teach-to-Goal (V-TTG); The RA will show the patient how to use the tablet to access the education module and be available for questions about the technology / tablet but not about the content. Within the module, the child will: answer questions about how to use the inhaler as part of a pre-video assessment.; watch a video about how to correctly use a Metered Dose Inhaler (MDI) and spacer.; answer questions on the tablet to assess how well they understand how to use the inhaler. If a child answers any questions incorrectly, they will watch the video again and have another chance to answer the incorrect questions. The child will receive instruction by video one or multiple times (up to 3 times), depending on how much they understand after each round of instruction, as demonstrated by their responses to questions.	Behavioral: Virtual Teach to Goal; Virtual Teach-to-Goal is an educational module that teaches children how to use their inhaler properly; this is done with an IPAD. In the module, the child will complete a series of questions as a pre-assessment, watch a video about how to use the inhaler properly, and then answer a series of questions as a post-assessment. If a child answers any questions incorrectly, they will watch the video again and have another chance to answer the incorrect questions. The child will receive instruction by video one or multiple times (up to 3 times), depending on how much they understand after each round of instruction, as demonstrated by their responses to questions.; Other Names: VTTG
Active Comparator: Brief Intervention (BI); The RA will give the patient a handout about inhaler technique and read the steps to the child.	Behavioral: Brief Intervention; There is a handout that describes proper inhaler technique. The RA reads the handout to the child.; Other Names: BI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants with metered dose inhaler (MDI) misuse immediately after V-TTG vs. BI education	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.	Initial study visit / baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Acceptability of V-TTG among children and parents based on Likert-scale questions (1-5)	Questionnaires of children and parents immediately after completing the V-TTG intervention. Likert-scale questions will focus on whether children and parents like the V-TTG education, would be willing to use, and would recommend to a friend.	Initial study visit - after completing V-TTG intervention
Usability of V-TTG among children and parents based on open-ended questions	Interviews with children and parents immediately after completing the V-TTG intervention. Open-ended questions will be utilized to assess what children and parents like or do not like about the module and how it could be utilized in clinical settings, at home, at school.	Initial study visit - after completing V-TTG intervention
Proportion of participants with metered dose inhaler (MDI) misuse in VTTG vs BI arms at 1 month after education	Retention of proper inhaler technique skills	Follow-up visit at 1 month
Self-efficacy: Questionnaire	Questionnaire with Likert-scale questions (1-5) to assess self-efficacy about inhaler technique pre vs post intervention	Initial study visit - at baseline and immediately after intervention

Collaborators and Investigators

• Sponsor: University of Chicago
• Collaborators: CHEST Foundation

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2019
• Primary Completion (Actual): February 27, 2020
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: November 9, 2018
• First Submitted That Met QC Criteria: April 29, 2020
• First Posted (Actual): May 4, 2020

Study Record Updates

• Last Update Posted (Actual): April 29, 2021
• Last Update Submitted That Met QC Criteria: April 27, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: Asthma; Education; Learning; Inhaler; Module; Virtual Teach to Goal
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Bronchial Diseases; Signs and Symptoms, Respiratory; Dyspnea; Bronchial Spasm
• Other Study ID Numbers: 18-1080

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