An Asthma Mobile Intervention to Promote Patient-Reported Outcomes in Primary Care

Study Overview
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Brief Summary
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Through this study, the investigators will adapt the ASTHMAXcel mobile app and evaluate the adapted intervention through a randomized controlled trial.

Detailed Description
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Through this study, the investigators will use patient and provider feedback to adapt the ASTHMAXcel mobile intervention, and will conduct a randomized controlled trial to test the intervention's impact on clinical and process outcomes.

Official Title
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Adapting, Scaling, and Spreading an Algorithmic Asthma Mobile Intervention to Promote Patient-Reported Outcomes Within Primary Care Settings

Conditions
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Asthma

Intervention / Treatment
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* Other: ASTHMAXcel mobile application
* Other: Outpatient primary care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: English-speaking individuals >18 years with: 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 completing the protocol patients that previously received ASTHMAXcel

Ages Eligible for Study
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Minimum Age: 18 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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Through the randomized controlled trial component, there will be 2 arms, which include the ASTHMAXcel intervention and usual care delivered through the outpatient primary care setting.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ASTHMAXcel arm<br>The ASTHMAXcel arm represents the study intervention, which is a patient-facing mobile application for adult patients with asthma. | Other: ASTHMAXcel mobile application<br>* ASTHMAXcel is a mobile application (patient-facing) that delivers guideline-based asthma education.<br>|
| Active Comparator: Usual care arm<br>This arm represents usual care delivered in the outpatient primary care setting at the study sites. | Other: Outpatient primary care<br>* Usual care delivered through the outpatient primary care setting<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline asthma quality of life to 2, 6, and 12 months | Patients' asthma quality of life measured by the mini-Asthma Quality of Life Questionnaire (mini-AQLQ) | Baseline, 2 months, 6 months, 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction measured by the Client Satisfaction Questionnaire-8 | Patient satisfaction measured by the Client Satisfaction Questionnaire-8 | Baseline, 2 months, 6 months, 12 months | 
| Provider perception of self-performance measured by the Asthma Physicians' Practice Assessment Questionnaire | Provider perception of self-performance measured by the Asthma Physicians' Practice Assessment Questionnaire | Baseline, 2 months, 6 months, 12 months | 
| Change from baseline asthma knowledge to 2 months, 6 months, and 12 months | Asthma knowledge as measured by the validated KASE asthma questionnaire | Baseline, 2 months, 6 months, 12 months | 
| Patient acceptance of ASTHMAXcel intervention as measured by the UTAUT questionnaire | Patient acceptance of ASTHMAXcel intervention as measured by the UTAUT questionnaire | Baseline, 2 months, 6 months, 12 months | 
| Change from baseline asthma control to 2, 6, and 12 months | Asthma symptom burden as measured by the Asthma Control Test | Baseline, 2 months, 6 months, 12 months | 
| Depression as measured by the Patient Health Questionnaire-9 | Depression as measured by the Patient Health Questionnaire-9 | Baseline, 2 months, 6 months, 12 months | 
| Number of asthma emergency department visits | Number of asthma emergency department visits | Baseline, 2 months, 6 months, 12 months | 
| Number of asthma hospitalizations | Number of asthma hospitalizations | Baseline, 2 months, 6 months, 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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informatics, asthma