An interventional study of Virtual Teach to Goal and Brief Intervention in Asthma, Bronchospasm and Shortness of Breath, sponsored by University of Chicago. Completed at 1 site in United States. Open to participants aged 5 Years to 10 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-04-29.
Sponsored by University of Chicago · Not applicable, Interventional, and Health services research
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.
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.
4,841 studies on the registry are indexed under Asthma; 600 are open to participants now.
This study's enrollment of 70 is below the median of 78 across 3,341 interventional studies indexed under Asthma.
Browse Asthma studies →University of Chicago is the lead sponsor of 924 studies on the registry; 185 are open to participants now.
Of its 103 completed or terminated interventional studies of FDA-regulated products, 72 (70%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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
The RA will give the patient a handout about inhaler technique and read the steps to the child.
Behavioral: Brief Intervention
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.
Also known as: VTTG
There is a handout that describes proper inhaler technique. The RA reads the handout to the child.
Also known as: BI
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.
Time frame: Initial study visit / baseline
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.
Time frame: Initial study visit - after completing V-TTG intervention
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.
Time frame: Initial study visit - after completing V-TTG intervention
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
Time frame: Follow-up visit at 1 month
Self-efficacy: Questionnaire
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
Plan to share: No
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This study is completed, as verified in Apr 2021. You cannot join it, but the record below documents what was studied.
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