Asthma Clinical Trial
— V-TTG vs BIOfficial title:
A Randomized Clinical Trial Evaluating the Effectiveness of Virtual Teach-to-Goal Education vs. Brief Intervention for Children
Verified date | April 2021 |
Source | University of Chicago |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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) |
Country | Name | City | State |
---|---|---|---|
United States | University of Chicago Medicine | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
University of Chicago | CHEST Foundation |
United States,
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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