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Completed

NCT Number: NCT04373499

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

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Key information

Conditions

Asthma Bronchial Diseases Bronchial Spasm Bronchospasm Dyspnea Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Hypersensitivity Respiratory Tract Diseases Shortness of Breath Signs and Symptoms Signs and Symptoms, Respiratory

Age range

5 year–10 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.

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.

Who can participate

Healthy volunteers accepted: Yes

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

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)

Treatment and study plan

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.

Other names: VTTG

Brief intervention

Behavioral

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

Other names: BI

Primary outcomes

  1. 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

  1. Acceptability of V-TTG among children and parents based on Likert-scale questions (1-5)

    Time frame: Initial study visit - after completing V-TTG intervention

    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.

  2. Usability of V-TTG among children and parents based on open-ended questions

    Time frame: Initial study visit - after completing V-TTG intervention

    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.

  3. Proportion of participants with metered dose inhaler (MDI) misuse in VTTG vs BI arms at 1 month after education

    Time frame: Follow-up visit at 1 month

    Retention of proper inhaler technique skills

  4. Self-efficacy: Questionnaire

    Time frame: Initial study visit - at baseline and immediately after intervention

    Questionnaire with Likert-scale questions (1-5) to assess self-efficacy about inhaler technique pre vs post intervention

Sponsors and collaborators

Lead sponsor

University of Chicago

Other

Collaborators

  • American College of Chest Physicians

Registry information

Official study title

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

Acronym: V-TTG vs BI

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 4, 2020
Registry last updated
Apr 29, 2021

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.

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