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Virtual Teach to Goal vs. Brief Intervention Inhaler Study-outpatient

Primary Purpose

Asthma in Children

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Virtual Teach to Goal
Brief Instruction
Sponsored by
University of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Asthma in Children

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Families will be included in the study if:

    1. The child is between the ages of 6-17 years old
    2. The child has a diagnosis of asthma, wheezing, or bronchospasm
    3. The child has been or is seen in general pediatrics, pediatric pulmonary, or pediatric allergy clinic at the University of Chicago Medical Center
    4. The child is taking medication for asthma, wheezing, or bronchospasm (either a controller medication or a quick-relief medication)
    5. The family has acess to wifi and/or data that supports virtual video-based platforms (if study is done virtually)

Exclusion Criteria:

  • Families will be excluded from the study if:

    1. The child/parent decline or unable to provide consent/assent
    2. The child/parent does not speak/read English
    3. The child cannot use an inhaler by themselves without a mask
    4. The child previously participated in this study
    5. The family does not have access to wifi and/or data that supports virtual video-based platforms (if study done virtually)

Sites / Locations

  • University of Chicago Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Virtual Teach-to-Goal (V-TTG)

standardized brief intervention

Arm Description

They will be randomized to receive education via a virtual learning module.

Intervention that mimics usual care to deliver inhaler technique education.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of inhaler technique steps correct pre- and post-V-TTG education
Evaluation of inhaler technique before and after education using validated checklist
Number of inhaler technique steps correct at 1 month
Evaluation of inhaler technique 1-month after education/baseline session
Score of Asthma Control Survey
Assessed using validated survey measure
Score of Asthma Impact
Assessed using validated survey measure
Score of Caregiver Quality of Life
Assessed using validated survey measure
Score of Child Asthma Management Self-Efficacy
Assessed using validated survey measure
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

Full Information

First Posted
April 16, 2020
Last Updated
February 17, 2022
Sponsor
University of Chicago
Collaborators
American Thoracic Society
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1. Study Identification

Unique Protocol Identification Number
NCT04470180
Brief Title
Virtual Teach to Goal vs. Brief Intervention Inhaler Study-outpatient
Official Title
An RCT of Virtual Teach-to-Goal Versus Brief Instruction for Children With Asthma in Clinics
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
November 5, 2021 (Actual)
Study Completion Date
November 5, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Chicago
Collaborators
American Thoracic Society

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma in Children

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Virtual Teach-to-Goal (V-TTG)
Arm Type
Experimental
Arm Description
They will be randomized to receive education via a virtual learning module.
Arm Title
standardized brief intervention
Arm Type
Active Comparator
Arm Description
Intervention that mimics usual care to deliver inhaler technique education.
Intervention Type
Behavioral
Intervention Name(s)
Virtual Teach to Goal
Intervention Description
Participants will complete inhaler education on a tablet device.
Intervention Type
Behavioral
Intervention Name(s)
Brief Instruction
Intervention Description
Participants will be read out loud instruction on how to use their inhaler.
Primary Outcome Measure Information:
Title
Proportion of participants with effective inhaler use (>75% steps correct) post-intervention with V-TTG versus BI
Description
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
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Number of inhaler technique steps correct pre- and post-V-TTG education
Description
Evaluation of inhaler technique before and after education using validated checklist
Time Frame
At baseline
Title
Number of inhaler technique steps correct at 1 month
Description
Evaluation of inhaler technique 1-month after education/baseline session
Time Frame
1-month after enrollment
Title
Score of Asthma Control Survey
Description
Assessed using validated survey measure
Time Frame
12-months
Title
Score of Asthma Impact
Description
Assessed using validated survey measure
Time Frame
12-months
Title
Score of Caregiver Quality of Life
Description
Assessed using validated survey measure
Time Frame
12-months
Title
Score of Child Asthma Management Self-Efficacy
Description
Assessed using validated survey measure
Time Frame
12-months
Title
Number of healthcare encounters self-reported and EHR-recorded since baseline
Description
Healthcare utilization measured via program-specific questionnaire delivered to parent and child as well as manual review of medical records
Time Frame
12-months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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) Exclusion Criteria: 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Volerman, MD
Organizational Affiliation
University of Chicago
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Chicago Medicine
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Virtual Teach to Goal vs. Brief Intervention Inhaler Study-outpatient

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