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

NCT04470180 | Completed DMC

• 1 other identifier: 192091
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma in Children

Outcome Measures

Primary Outcomes (1)

• 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

  12 months

Secondary Outcomes (7)

• Number of inhaler technique steps correct pre- and post-V-TTG education

  At baseline

• Number of inhaler technique steps correct at 1 month

  1-month after enrollment

• Score of Asthma Control Survey

  12-months

• Score of Asthma Impact

  12-months

• Score of Caregiver Quality of Life

  12-months

Study Arms (2)

Virtual Teach-to-Goal (V-TTG)

EXPERIMENTAL

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

Behavioral: Virtual Teach to Goal

standardized brief intervention

ACTIVE COMPARATOR

Intervention that mimics usual care to deliver inhaler technique education.

Behavioral: Brief Instruction

Interventions

Virtual Teach to Goal BEHAVIORAL

Participants will complete inhaler education on a tablet device.

Virtual Teach-to-Goal (V-TTG)

Brief Instruction BEHAVIORAL

Participants will be read out loud instruction on how to use their inhaler.

standardized brief intervention

Eligibility Criteria

• Age: 6 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Chicago: lead
• American Thoracic Society: collaborator

Study Sites (1)

University of Chicago Medicine

Chicago, Illinois, 60637, United States

Location

Study Officials

• Anna Volerman, MD

  University of Chicago

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2020
• First Posted: July 14, 2020
• Study Start: August 1, 2020
• Primary Completion: November 5, 2021
• Study Completion: November 5, 2021
• Last Updated: February 18, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)