AsthmaV-TTG vs BINCT04373499
Virtual Teach-to-Goal Education vs. Brief Education for Children
A study testing Virtual Teach to Goal and Brief Intervention in people with Asthma and Bronchospasm, run by University of Chicago at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 5 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Asthma, Bronchospasm, Shortness of Breath
- What is being tested?
- Virtual Teach to Goal and Brief Intervention
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 16 Jan 2019to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 5 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Chicago Medicine
Chicago, Illinois, 60637
About this study
Official title: A Randomized Clinical Trial Evaluating the Effectiveness of Virtual Teach-to-Goal Education vs. Brief Intervention for Children
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.
Read the 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.
- Conditions
- Asthma, Bronchospasm, Shortness of Breath
- Being tested
- Virtual Teach to Goal, Brief Intervention
- Keywords
- Inhaler, Education, Asthma, Learning, Module, Virtual Teach to Goal
- Medical subject headings
- Asthma, Bronchial Spasm, Dyspnea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Teach to GoalBehavioural
Also called VTTG
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.
Brief InterventionBehavioural
Also called BI
There is a handout that describes proper inhaler technique. The RA reads the handout to the child.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Teach-to-Goal (V-TTG) | Experimental | 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. Receives: Behavioral: Virtual Teach to Goal |
| Brief Intervention (BI) | Active comparator | The RA will give the patient a handout about inhaler technique and read the steps to the child. Receives: Behavioral: Brief Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Initial study visit / baseline
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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
Measured: 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
Measured: Initial study visit - at baseline and immediately after intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2020
- Study start16 Jan 2019
- Primary completion27 Feb 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- American College of Chest Physicians
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04373499
- Sponsor's protocol ID
- 18-1080
- Acronym
- V-TTG vs BI
- Status last verified
- Apr 2021
- First submitted
- 9 Nov 2018
- Last updated
- 29 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Volerman A, Balachandran U, Zhu M, Akel M, Hull A, Siros M, Luna V, Xu I, Press VG. Evaluating inhaler education interventions for hospitalized children with asthma: A randomized controlled trial. Ann Allergy Asthma Immunol. 2023 Aug;131(2):217-223.e1. doi: 10.1016/j.anai.2023.02.023. Epub 2023 Mar 3.
PubMed 36870528
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Clinical Trial Evaluating the Effectiveness of Virtual Teach-to-Goal Education vs. Brief Intervention for Children
- ClinicalTrials.gov ID
- NCT04373499
- Acronym / sponsor ID
- V-TTG vs BI / 18-1080
- Conditions
- Asthma, Bronchospasm, Shortness of Breath
- Keywords
- Inhaler, Education, Asthma, Learning, Module, Virtual Teach to Goal
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- American College of Chest Physicians
- Study start
- 16 Jan 2019 (actual)
- Primary completion
- 27 Feb 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 4 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- 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).
| Arm | Type | Receives |
|---|---|---|
| Virtual Teach-to-Goal (V-TTG) | Experimental | Behavioral: Virtual Teach to GoalThe 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 InterventionThe RA will give the patient a handout about inhaler technique and read the steps to the child. |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual Teach to GoalAlso: VTTGVirtual 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. | Behavioural | Virtual Teach-to-Goal (V-TTG) |
| Brief InterventionAlso: BIThere is a handout that describes proper inhaler technique. The RA reads the handout to the child. | Behavioural | Brief Intervention (BI) |
Primary outcome
Proportion of participants with metered dose inhaler (MDI) misuse immediately after V-TTG vs. BI education
Time frame: 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.
4 secondary outcomes
Acceptability of V-TTG among children and parents based on Likert-scale questions (1-5)
Time frame: Initial study visit - after completing V-TTG intervention
Usability of V-TTG among children and parents based on open-ended questions
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
Time frame: Follow-up visit at 1 month
Self-efficacy: Questionnaire
Time frame: Initial study visit - at baseline and immediately after intervention
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2021.
- Derived from this study: PubMed 36870528Volerman A, Balachandran U, Zhu M, Akel M, Hull A, Siros M, Luna V, Xu I, Press VG. Evaluating inhaler education interventions for hospitalized children with asthma: A randomized controlled trial. Ann Allergy Asthma Immunol. 2023 Aug;131(2):217-223.e1. doi: 10.1016/j.anai.2023.02.023. Epub 2023 Mar 3.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual Teach to Goal and Brief Intervention in people with Asthma and Bronchospasm, run by University of Chicago at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants with metered dose inhaler (MDI) misuse immediately after V-TTG vs. BI education (time frame: Initial study visit / baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04373499, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2021.