Asthma in ChildrenNCT04470180
Virtual Teach to Goal vs. Brief Intervention Inhaler Study-outpatient
A study testing Virtual Teach to Goal and Brief Instruction in people with Asthma in Children, run by University of Chicago at 1 site in United States.
Trial summary
This study aims to evaluate the comparative effectiveness of a high-fidelity, low-resource, and feasible model versus a standardized brief intervention that mimics usual care to deliver tailored inhaler technique education to children with asthma via a randomized clinical trial. Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Asthma in Children
- What is being tested?
- Virtual Teach to Goal and Brief Instruction
- 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
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Aug 2020to 5 Nov 2021
- 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 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Families will be included in the study if:
- The child is between the ages of 6-17 years old
- The child has a diagnosis of asthma, wheezing, or bronchospasm
- The child has been or is seen in general pediatrics, pediatric pulmonary, or pediatric allergy clinic at the University of Chicago Medical Center
- The child is taking medication for asthma, wheezing, or bronchospasm (either a controller medication or a quick-relief medication)
- The family has acess to wifi and/or data that supports virtual video-based platforms (if study is done virtually)
Who cannot join
- Families will be excluded from the study if:
- The child/parent decline or unable to provide consent/assent
- The child/parent does not speak/read English
- The child cannot use an inhaler by themselves without a mask
- The child previously participated in this study
- The family does not have access to wifi and/or data that supports virtual video-based platforms (if study done virtually)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Chicago Medicine
Chicago, Illinois, 60637
About this study
Official title: An RCT of Virtual Teach-to-Goal Versus Brief Instruction for Children With Asthma in Clinics
This study aims to evaluate the comparative effectiveness of a high-fidelity, low-resource, and feasible model versus a standardized brief intervention that mimics usual care to deliver tailored inhaler technique education to children with asthma via a randomized clinical trial. We have already conducted a trial of V-TTG among elementary school-aged children hospitalized in the inpatient setting and we now aim to test this tool in the outpatient clinic setting among a broader pediatric patient population.
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. Urban, minority, and underserved youth are disproportionally affected. On Chicago's South Side, one-in-five children have an asthma diagnosis; over half visit an urgent care or emergency department (55%), miss school (51.2%), or require parents to miss work annually due to asthma (56.1%).
Effective self-management is crucial to optimize asthma care and improve outcomes. A key barrier to self-management is the 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. Our team developed a V-TTG intervention for adults with demonstrated efficacy. It remains unknown whether this interactive and adaptive module will be feasible and effective in the pediatric population due to varied developmental levels and parental involvement in care.
Virtual Teach-to-Goal (V-TTG) holds the potential to improve inhaler technique in children; however, because learning theory indicates children and adults learn differently, the same learning module cannot be utilized. We have already constructed V-TTG for children with feedback from children with asthma, parents, and healthcare professionals. The learning module is tailored for age by using developmentally and age-appropriate vocabulary, concepts, format, and pacing.
- Conditions
- Asthma in Children
- Being tested
- Virtual Teach to Goal, Brief Instruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual Teach to GoalBehavioural
Participants will complete inhaler education on a tablet device.
Brief InstructionBehavioural
Participants will be read out loud instruction on how to use their inhaler.
| Study group | Role | What they receive |
|---|---|---|
| Virtual Teach-to-Goal (V-TTG) | Experimental | They will be randomized to receive education via a virtual learning module. Receives: Behavioral: Virtual Teach to Goal |
| standardized brief intervention | Active comparator | Intervention that mimics usual care to deliver inhaler technique education. Receives: Behavioral: Brief Instruction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants with effective inhaler use (>75% steps correct) post-intervention with V-TTG versus BI
Inhaler technique will be assessed based on a validated published checklist, which was developed and validated by Dr. Press15 and utilized in my preliminary research with children (see Preliminary Studies). For this primary outcome, we will account for the pre-intervention technique to account for any differences in baseline of the two groups
Measured: 12 months
Secondary outcomes (7)
Number of inhaler technique steps correct pre- and post-V-TTG education
Evaluation of inhaler technique before and after education using validated checklist
Measured: At baseline
Number of inhaler technique steps correct at 1 month
Evaluation of inhaler technique 1-month after education/baseline session
Measured: 1-month after enrollment
Score of Asthma Control Survey
Assessed using validated survey measure
Measured: 12-months
Score of Asthma Impact
Assessed using validated survey measure
Measured: 12-months
Score of Caregiver Quality of Life
Assessed using validated survey measure
Measured: 12-months
Score of Child Asthma Management Self-Efficacy
Assessed using validated survey measure
Measured: 12-months
Number of healthcare encounters self-reported and EHR-recorded since baseline
Healthcare utilization measured via program-specific questionnaire delivered to parent and child as well as manual review of medical records
Measured: 12-months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2020
- Study start1 Aug 2020
- Primary completion5 Nov 2021
- Study completion5 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma in ChildrenStudies 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
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- American Thoracic Society
- Responsible party
- Sponsor
- Investigators
- Anna Volerman, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04470180
- Sponsor's protocol ID
- 192091
- Status last verified
- Feb 2022
- First submitted
- 16 Apr 2020
- Last updated
- 18 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An RCT of Virtual Teach-to-Goal Versus Brief Instruction for Children With Asthma in Clinics
- ClinicalTrials.gov ID
- NCT04470180
- Acronym / sponsor ID
- 192091
- Conditions
- Asthma in Children
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- American Thoracic Society
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 5 Nov 2021 (actual)
- Study completion
- 5 Nov 2021 (actual)
- First posted
- 14 Jul 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.
This study aims to evaluate the comparative effectiveness of a high-fidelity, low-resource, and feasible model versus a standardized brief intervention that mimics usual care to deliver tailored inhaler technique education to children with asthma via a randomized clinical trial. We have already conducted a trial of V-TTG among elementary school-aged children hospitalized in the inpatient setting and we now aim to test this tool in the outpatient clinic setting among a broader pediatric patient population.
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. Urban, minority, and underserved youth are disproportionally affected. On Chicago's South Side, one-in-five children have an asthma diagnosis; over half visit an urgent care or emergency department (55%), miss school (51.2%), or require parents to miss work annually due to asthma (56.1%).
Effective self-management is crucial to optimize asthma care and improve outcomes. A key barrier to self-management is the 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. Our team developed a V-TTG intervention for adults with demonstrated efficacy. It remains unknown whether this interactive and adaptive module will be feasible and effective in the pediatric population due to varied developmental levels and parental involvement in care.
Virtual Teach-to-Goal (V-TTG) holds the potential to improve inhaler technique in children; however, because learning theory indicates children and adults learn differently, the same learning module cannot be utilized. We have already constructed V-TTG for children with feedback from children with asthma, parents, and healthcare professionals. The learning module is tailored for age by using developmentally and age-appropriate vocabulary, concepts, format, and pacing.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Virtual Teach-to-Goal (V-TTG) | Experimental | Behavioral: Virtual Teach to GoalThey will be randomized to receive education via a virtual learning module. |
| standardized brief intervention | Active comparator | Behavioral: Brief InstructionIntervention that mimics usual care to deliver inhaler technique education. |
Who may qualify
- Ages
- 6 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Families will be included in the study if:
Key exclusion criteria (6 listed)
- Families will be excluded from the study if:
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 GoalParticipants will complete inhaler education on a tablet device. | Behavioural | Virtual Teach-to-Goal (V-TTG) |
| Brief InstructionParticipants will be read out loud instruction on how to use their inhaler. | Behavioural | standardized brief intervention |
Primary outcome
Proportion of participants with effective inhaler use (>75% steps correct) post-intervention with V-TTG versus BI
Time frame: 12 months
Inhaler technique will be assessed based on a validated published checklist, which was developed and validated by Dr. Press15 and utilized in my preliminary research with children (see Preliminary Studies). For this primary outcome, we will account for the pre-intervention technique to account for any differences in baseline of the two groups
7 secondary outcomes
Number of inhaler technique steps correct pre- and post-V-TTG education
Time frame: At baseline
Number of inhaler technique steps correct at 1 month
Time frame: 1-month after enrollment
Score of Asthma Control Survey
Time frame: 12-months
Score of Asthma Impact
Time frame: 12-months
Score of Caregiver Quality of Life
Time frame: 12-months
Score of Child Asthma Management Self-Efficacy
Time frame: 12-months
Number of healthcare encounters self-reported and EHR-recorded since baseline
Time frame: 12-months
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 18 Feb 2022.
- 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.
Anna Volerman, MD principal investigator
University of Chicago
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 Instruction in people with Asthma in Children, 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 6 inclusion and 6 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 18 Feb 2022. 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 effective inhaler use (>75% steps correct) post-intervention with V-TTG versus BI (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Feb 2022.