Adapting and Expanding the Asthma-Educator App

Study Overview
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Brief Summary
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This project seeks to test and refine an adapted/expanded version of a previously created ASTHMAXcel app.

Detailed Description
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The study will test the adapted app on participants ages 15-21 (recruited from outpatient primary and specialty care sites at Montefiore) with asthma, for a period of 4 and a half months, and will conduct formative and summative evaluation of the application's functionality and usability. The investigators will also be collecting process and clinical outcomes.

Official Title
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Adapting and Expanding the Algorithmic Software Tool to Help Manage Asthma (ASTHMAXcel) for Youth With Asthma

Conditions
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Asthma

Intervention / Treatment
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* Other: ASTHMAXcel App


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: English-speaking individuals between 15-21 Persistent asthma (diagnosis made by a healthcare provider) On a daily controller medication Able to give informed consent Smartphone (iOS or Android) access Exclusion Criteria: Use of oral corticosteroids in the 2 weeks prior to the baseline visit Pregnancy Severe psychiatric or cognitive problems that would prohibit an individual from understanding and completing the protocol Patients that previously received the ASTHMA-Educator application

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: Study will eventually compare health outcomes between a group given the ASTHMAXcel intervention and a group given Usual Care
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention Arm<br>This group will download the ASTHMAXcel application and use it for the duration of the study | Other: ASTHMAXcel App<br>* ASTHMAXcel includes interactive games, educational videos, quizzes and personalized feedback to teach different aspects of asthma management.<br>|
| No Intervention: Usual Care Arm<br>This group will just receive normal provider care | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from Baseline Asthma Control to 3 Month Asthma Control | Asthma symptom burden as measured by the Asthma Control Test Score Scale: 5 (min = worse); 25 (max = better outcome) | Post-Refinement Baseline, 3 Months | 
| Change from Baseline Asthma Control to 3 Month Asthma Control | Asthma symptom burden as measured by the Asthma Control Test Score Scale: 5 (min = worse); 25 (max = better outcome) | Post-Refinement Baseline, 4 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Asthma Symptom Perception | Ability of participants to perceive their asthma symptoms by using the ASTHMAXcel app and a peak flowmeter | Week 2, Week 4 , Week 6 (Pre and Post Refinement) | 
| Asthma Knowledge | Will use the Child Asthma Illness Representation Survey (AIRS) to asses patients knowledge on asthma as well as their attitudes towards their condition. Score Scale: 4 (min = worse outcome); 20 (max = better outcome) | Post-Refinement Baseline, 3 Month | 
| Medication Adherence | Self-reported adherence by patient using Medication Adherence Report Scale Score Scale: 10 (min = worse outcome); 50 (max = better outcome) | Post-Refinement Baseline, 3 Month | 
| Asthma Quality of Life | Quality of life of participants, measured by mini-Asthma Quality of Life Questionnaire Score Scale: 15 (min = worse outcome); 105 (max = better outcome) | Post-Refinement Baseline, 3 Month | 
| Emergency Department Visits | Self-Reported Emergency Department (ED) visits | Post-Refinement Baseline, 3 Month | 
| Patient Satisfaction | Patient satisfaction with study measured by the Client Satisfaction Questionnaire-8 Score Scale: 8 (min = worse outcome); 32 (max = better outcome) | Post-Refinement Baseline, 3 Month | 
| Patient Interface Satisfaction | Patient satisfaction with ASTHMAXcel app interface measured by Questionnaire for User Interface Survey (QUIS) Score Scale: 0 (min = worse outcome); 261 (max = better outcome) Answers scale from 0 (terrible/hard to understand)) to 9 (wonderful/easy to understand) | Post-Refinement Baseline, 3 Month | 
| Patient Usage | Time spent on app and different screens of app, measured using Google Analytics | Baseline, 3 Month | 
| Health Literacy | Ability for patients to comprehend Newest Vital Sign screening tool | Post-Refinement Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma