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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-16

Study Completion Date

2020-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Video vs. TTG Respiratory Inhaler Technique Assessment and InstructioN (V-TRaIN)

NCT02611531

Chronic Obstructive Pulmonary Disease Asthma

COMPLETED NA

The Effect of Video Education on Inhaler Use Technique

NCT02660879

Nebulizers and Vaporizers Patient Education E Learning

COMPLETED NA

Comparing the Efficacy of Two Valved Holding Chambers in Acute Wheezing

NCT03900494

Bronchitis Obstructive Bronchiolitis; Obstruction Bronchospasm; Bronchitis

COMPLETED NA

Non-invasive Ventilation vs. Standard Therapy for Children Hospitalized With an Acute Exacerbation of Asthma

NCT03296579

Asthma Acute Asthma in Children

UNKNOWN NA

Simulation Training in the Pediatric Tracheostomy and Home Ventilator Population

NCT04308109

Tracheostomy Complication Simulation of Physical Illness Teach-Back Communication

ACTIVE_NOT_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Asthma Bronchospasm Shortness of Breath

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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).

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Virtual Teach to Goal

Intervention Type 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.

Brief Intervention (BI)

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

Group Type ACTIVE_COMPARATOR

Brief Intervention

Intervention Type BEHAVIORAL

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Brief Intervention

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

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

VTTG BI

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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)

Minimum Eligible Age

5 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes