Virtual Teach-to-Goal Education vs. Brief Education for Children

NCT04373499 | Completed DMC

• 1 other identifier: 18-1080
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma; Bronchospasm; Shortness of Breath

Keywords

Inhaler; Education; Asthma; Learning; Module; Virtual Teach to Goal

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• 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

• 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

• Self-efficacy: Questionnaire

  Initial study visit - at baseline and immediately after intervention

Study Arms (2)

Virtual Teach-to-Goal (V-TTG)

EXPERIMENTAL

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

Brief Intervention (BI)

ACTIVE COMPARATOR

The RA will give the patient a handout about inhaler technique and read the steps to the child.

Behavioral: Brief Intervention

Interventions

Virtual Teach to Goal BEHAVIORAL

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.

Also known as: VTTG

Virtual Teach-to-Goal (V-TTG)

Brief Intervention BEHAVIORAL

There is a handout that describes proper inhaler technique. The RA reads the handout to the child.

Also known as: BI

Brief Intervention (BI)

Eligibility Criteria

• Age: 5 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Chicago: lead
• American College of Chest Physicians: collaborator

Study Sites (1)

University of Chicago Medicine

Chicago, Illinois, 60637, United States

Location

Related Publications (1)

• Volerman A, Balachandran U, Zhu M, Akel M, Hull A, Siros M, Luna V, Xu I, Press VG. Evaluating inhaler education interventions for hospitalized children with asthma: A randomized controlled trial. Ann Allergy Asthma Immunol. 2023 Aug;131(2):217-223.e1. doi: 10.1016/j.anai.2023.02.023. Epub 2023 Mar 3.

  PMID: 36870528 DERIVED

MeSH Terms

Conditions

Asthma; Bronchial Spasm; Dyspnea

Interventions

Crisis Intervention

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Psychotherapy; Behavioral Disciplines and Activities

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: We will conduct a single-site randomized clinical trial of V-TTG versus brief intervention (BI) for school-aged children (5-11 years) with severe asthma hospitalized at University of Chicago Comer Children's Hospital. We aim to enroll 70 participants. The project team will identify eligible children who meet inclusion criteria. Block randomization will be utilized, stratified by age (5-8 vs. 9-11 years).

Study Record Dates

• First Submitted: November 9, 2018
• First Posted: May 4, 2020
• Study Start: January 16, 2019
• Primary Completion: February 27, 2020
• Study Completion: December 31, 2020
• Last Updated: April 29, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)