ASTHMAXcel Emergency Department Study
- Conditions
- Asthma AttackAsthma
- Interventions
- Other: ASTHMAXcel ED Application
- Registration Number
- NCT05013073
- Lead Sponsor
- Montefiore Medical Center
- Brief Summary
This protocol focuses on Phase 1 of a planned two-phase research project. Phase 1 aims to test and adapt a prototype ASTHMAXcelED application for the ED. Phase 2 will be an RCT to test the efficacy of a refined ASTHMAXcelED app after being modified based on the results of Phase 1.
- Detailed Description
The original ASTHMAxcel app was developed by Dr. Jariwala, which delivers asthma education and promotes patients' adherence to the national asthma guidelines. The app was developed in accordance with Montefiore Medical Center's regulatory/compliance (determined by the Montefiore Legal department and Einstein-Montefiore Office of Biotechnology) and security (determined by Montefiore IT) policies. Over the last several years the app has been iteratively improved based on patient feedback and has been shown to improve asthma knowledge, asthma control, and asthma-related quality of life among asthma clinic patients. This version of the app has been tailored to the ED, requiring less physician directed education and focusing on common triggers and symptom management. Research associates will ask each patient to download the ASTHMAXcelED app and RA's instruct them on use of the application. RA's will also show every patient a video using the ASTHMAXcelED mobile application in which the investigators demonstrate correct use of an inhaler and discuss asthma triggers.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 160
- English speakers
- at least 18+ years old with
- physician-diagnosed asthma.
- severe cognitive or psychiatric conditions precluding capacity to provide informed consent,
- inability to speak English,
- lacking the technology to access the app.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Experimental Arm ASTHMAXcel ED Application All patients will be enrolled in a single arm and download the mobile application ASTHMAxcel ED to their smartphones.
- Primary Outcome Measures
Name Time Method Asthma Control Test (ACT) 4 Week Period A patient self-administered tool for identifying those with poorly controlled asthma.
- Secondary Outcome Measures
Name Time Method mini Asthma Quality of Life Questionnaire (mini AQLQ) Recall over 2 week period Based on the 32 item AQLQ, the mini AQLQ is a 15-item self-administered tool constructed to meet the efficiency needs of large-scale clinical trials. The instrument was constructed for adults, and shown to have good reliability, responsiveness, construct and criterion validity. It captures functional impairments most relevant to adult asthma patients over a 2 week recall period. The tool is scored on a 7 point Likert scale, with increasing values corresponding with worsening quality of life.
Unified Theory of Acceptance and use of Technology Measured at 4 weeks after intervention UTAUT explains user intention and behavior regarding the adoption of new technology. It explains user interaction using 4 domains: 1) performance expectancy, 2) effort expectancy, 3) social influence, and 4) facilitating conditions. The model explained 70% of the variance in Behavioral Intention to Use (BI) and about 50% in actual use, and has been validated against eight similar models and across nine culturally diverse nations.
Trial Locations
- Locations (2)
Montefiore Medical Center, Weiler Campus
🇺🇸Bronx, New York, United States
Montefiore Medical Center, Moses Campus
🇺🇸Bronx, New York, United States