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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04373499
Other study ID # 18-1080
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 16, 2019
Est. completion date December 31, 2020

Study information

Verified date April 2021
Source University of Chicago
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 70
Est. completion date December 31, 2020
Est. primary completion date February 27, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 5 Years to 10 Years
Eligibility 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 Design


Intervention

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

Locations

Country Name City State
United States University of Chicago Medicine Chicago Illinois

Sponsors (2)

Lead Sponsor Collaborator
University of Chicago CHEST Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
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