ASTHMA-Educator Mobile Application Manage Asthma

Study Overview
=================
Brief Summary
-----------------
Through this study, the investigators developed the ASTHMA-Educator mobile application, and evaluated its use among adult asthma patients at Montefiore.

Detailed Description
-----------------
Through this study, the investigators developed the ASTHMA-Educator mobile application, and evaluated its use through 2 phases: 1) Phase 1 = process outcomes evaluation with 30 patients); and 2) Phase 2 (longitudinal clinical evaluation with 40 patients receiving the intervention at baseline, 2 months, 4 months, and 6 months). The study's primary outcome is asthma control.

Official Title
-----------------
The ASTHMA-Educator: A Novel Algorithmic Software Tool to Help Manage Asthma

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Other: ASTHMA-Educator mobile application


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults (>18 years) with: (a) severe asthma (i.e. at least one asthma-related ED visit and/or hospitalization in the previous year); (b) access to a smartphone with short message service (SMS) capability; (c) English speaking; (d) able to give informed consent. Exclusion Criteria: (a) use of oral corticosteroids in the 2 weeks prior to the baseline visit; (b) pregnancy; (c) severe psychiatric or cognitive problems that would prohibit an individual from understanding and completing the protocol; and (d) patients that previously received the ASTHMAXcel application.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Health Services Research
Intervention Model: Single Group Assignment
Interventional Model Description: This is a single-arm proof of concept study to evaluate the impact of the ASTHMA-Educator on process and clinical outcomes
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ASTHMA-Educator arm<br>The ASTHMA-Educator mobile application for patient-centered asthma education. The application is administered via on-site iPad (tablet). | Other: ASTHMA-Educator mobile application<br>* The on-site delivered ASTHMA-Educator mobile application.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline asthma control to 2, 4, and 6 months | Asthma symptom burden as measured by the Asthma Control Test | Baseline, 2 months, 4 months, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline asthma knowledge to immediately post-intervention, 2 months, 4 months, and 6 months | Asthma knowledge as measured by the validated Asthma Knowledge Questionnaire | Baseline, immediately post-intervention, 2 months, 4 months, 6 months | 
| Patient satisfaction measured by the Client Satisfaction Questionnaire-8 | Patient satisfaction measured by the Client Satisfaction Questionnaire-8 | Immediately post-intervention at the baseline visit, 2 months, 4 months, 6 months | 
| Time spent in using the mobile application | Time spent in using the mobile application | Immediately post-intervention at the baseline visit | 
| Asthma quality of life measured by the mini-Asthma Quality of Life Questionnaire (mini-AQLQ) | Patients' asthma quality of life measured by the mini-Asthma Quality of Life Questionnaire (mini-AQLQ) | Baseline, 2 months, 4 months, 6 months | 
| Asthma emergency department visits | Asthma emergency department visits | Baseline, 2 months, 4 months, 6 months | 
| Asthma hospitalizations | Asthma hospitalizations | Baseline, 2 months, 4 months, 6 months | 
| Asthma-related steroid courses | Asthma-related steroid courses | Baseline, 2 months, 4 months, 6 months | 

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