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Virtual Teach-to-Goal Education vs. Brief Education for Children (V-TTG vs BI)

Primary Purpose

Asthma, Bronchospasm, Shortness of Breath

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual Teach to Goal
Brief Intervention
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Asthma focused on measuring Inhaler, Education, Asthma, Learning, Module, Virtual Teach to Goal

Eligibility Criteria

5 Years - 10 Years (Child)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • University of Chicago Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Virtual Teach-to-Goal (V-TTG)

Brief Intervention (BI)

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
November 9, 2018
Last Updated
April 27, 2021
Sponsor
University of Chicago
Collaborators
CHEST Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04373499
Brief Title
Virtual Teach-to-Goal Education vs. Brief Education for Children
Acronym
V-TTG vs BI
Official Title
A Randomized Clinical Trial Evaluating the Effectiveness of Virtual Teach-to-Goal Education vs. Brief Intervention for Children
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
January 16, 2019 (Actual)
Primary Completion Date
February 27, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
Collaborators
CHEST Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Bronchospasm, Shortness of Breath
Keywords
Inhaler, Education, Asthma, Learning, Module, Virtual Teach to Goal

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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).
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Virtual Teach-to-Goal (V-TTG)
Arm Type
Experimental
Arm Description
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.
Arm Title
Brief Intervention (BI)
Arm Type
Active Comparator
Arm Description
The RA will give the patient a handout about inhaler technique and read the steps to the child.
Intervention Type
Behavioral
Intervention Name(s)
Virtual Teach to Goal
Other Intervention Name(s)
VTTG
Intervention Description
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
Intervention Name(s)
Brief Intervention
Other Intervention Name(s)
BI
Intervention Description
There is a handout that describes proper inhaler technique. The RA reads the handout to the child.
Primary Outcome Measure Information:
Title
Proportion of participants with metered dose inhaler (MDI) misuse immediately after V-TTG vs. BI education
Description
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.
Time Frame
Initial study visit / baseline
Secondary Outcome Measure Information:
Title
Acceptability of V-TTG among children and parents based on Likert-scale questions (1-5)
Description
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.
Time Frame
Initial study visit - after completing V-TTG intervention
Title
Usability of V-TTG among children and parents based on open-ended questions
Description
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.
Time Frame
Initial study visit - after completing V-TTG intervention
Title
Proportion of participants with metered dose inhaler (MDI) misuse in VTTG vs BI arms at 1 month after education
Description
Retention of proper inhaler technique skills
Time Frame
Follow-up visit at 1 month
Title
Self-efficacy: Questionnaire
Description
Questionnaire with Likert-scale questions (1-5) to assess self-efficacy about inhaler technique pre vs post intervention
Time Frame
Initial study visit - at baseline and immediately after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
10 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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)
Facility Information:
Facility Name
University of Chicago Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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