Clinical trial NCT04373499: Virtual Teach-to-Goal Education vs. Brief Education for Children
Official title: A Randomized Clinical Trial Evaluating the Effectiveness of Virtual Teach-to-Goal Education vs. Brief Intervention for Children
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Asthma
Bronchospasm
Shortness of Breath
Keywords: Inhaler
Education
Asthma
Learning
Module
Virtual Teach to Goal
Lead sponsor: University of Chicago
Sponsor class: OTHER
Collaborators: name: American College of Chest Physicians
First posted: 2020-05-04
Enrollment: 70
Sex: ALL
Minimum age (years): 5
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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 purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Proportion of participants with metered dose inhaler (MDI) misuse immediately after V-TTG vs. BI education
timeFrame: Initial study visit / baseline
Secondary outcomes:
measure: Acceptability of V-TTG among children and parents based on Likert-scale questions (1-5)
timeFrame: Initial study visit - after completing V-TTG intervention
measure: Usability of V-TTG among children and parents based on open-ended questions
timeFrame: Initial study visit - after completing V-TTG intervention
measure: Proportion of participants with metered dose inhaler (MDI) misuse in VTTG vs BI arms at 1 month after education
timeFrame: Follow-up visit at 1 month
measure: Self-efficacy: Questionnaire
timeFrame: Initial study visit - at baseline and immediately after intervention
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago Medicine
state: Illinois
Study officials:
References: