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

Sponsor

University of Chicago (Other)

Overall Status

Completed

CT.gov ID

NCT04373499

Collaborator

CHEST Foundation (Other)

Enrollment

Location

Arms

23.5

Actual Duration (Months)

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Asthma Bronchospasm Shortness of Breath	Behavioral: Virtual Teach to Goal Behavioral: Brief Intervention	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

70 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

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).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:

Single (Outcomes Assessor)

Primary Purpose:

Health Services Research

Official Title:

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

Actual Study Start Date :

Jan 16, 2019

Actual Primary Completion Date :

Feb 27, 2020

Actual Study Completion Date :

Dec 31, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	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. Other Names: VTTG
Active Comparator: Brief Intervention (BI) The RA will give the patient a handout about inhaler technique and read the steps to the child.	Behavioral: Brief Intervention There is a handout that describes proper inhaler technique. The RA reads the handout to the child. Other Names: BI

Arm

Intervention/Treatment

Experimental: 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.

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.

Other Names:

VTTG

Active Comparator: Brief Intervention (BI)

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

Behavioral: Brief Intervention

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

Other Names:

Outcome Measures

Primary Outcome Measures

Proportion of participants with metered dose inhaler (MDI) misuse immediately after V-TTG vs. BI education [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 Outcome Measures

Acceptability of V-TTG among children and parents based on Likert-scale questions (1-5) [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.
Usability of V-TTG among children and parents based on open-ended questions [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.
Proportion of participants with metered dose inhaler (MDI) misuse in VTTG vs BI arms at 1 month after education [Follow-up visit at 1 month]
Retention of proper inhaler technique skills
Self-efficacy: Questionnaire [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

5 Years to 10 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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)