A Randomized Clinical Trial Evaluating the Effectiveness of Virtual Teach-to-Goal Education vs. Brief Intervention for Children
| Registry | NCT04373499, acronym V-TTG vs BI |
|---|---|
| Status | Completed |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: single, health services research |
| Enrollment | 70 (Actual) |
| Sponsor | University of Chicago (Other); collaborators: American College of Chest Physicians |
| Conditions | Asthma, Bronchospasm, Shortness of Breath |
| Interventions | Virtual Teach to Goal, Brief Intervention (Behavioral) |
| Dates | start 2019-01-16, primary completion 2020-02-27, completion 2020-12-31, first posted 2020-05-04, last updated 2021-04-29 |
| Locations | 1 site in United States |
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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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Virtual Teach-to-Goal (V-TTG) | Experimental | Behavioral: Virtual Teach to Goal | 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. |
| Brief Intervention (BI) | Active comparator | Behavioral: Brief Intervention | The RA will give the patient a handout about inhaler technique and read the steps to the child. |
Sex: All, ages: 5 Years to 10 Years, accepts 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)
| Facility | City | Country | Status |
|---|---|---|---|
| University of Chicago Medicine | Chicago, Illinois | United States |