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ASTHMAXcel Emergency Department Study

Adapting the ASTHMAxcel ED Application to Improve Asthma Related Patient-Centered Outcomes and Health Care Resource Utilization

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05013073
Acronym
ASTHMAXcel
Enrollment
160
Registered
2021-08-19
Start date
2021-05-01
Completion date
2023-02-07
Last updated
2023-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma, Asthma Attack

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.

Interventions

OTHERASTHMAXcel ED Application

A mobile application designed to assist patients in asthma symptom recognition, treatment best practices, and trigger identification.

Sponsors

Montefiore Medical Center
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE

Masking description

Open Label.

Intervention model description

Single arm prospective open label study

Eligibility

Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

* English speakers * at least 18+ years old with * physician-diagnosed asthma.

Exclusion criteria

* severe cognitive or psychiatric conditions precluding capacity to provide informed consent, * inability to speak English, * lacking the technology to access the app.

Design outcomes

Primary

MeasureTime frameDescription
Asthma Control Test (ACT)4 Week PeriodA patient self-administered tool for identifying those with poorly controlled asthma.

Secondary

MeasureTime frameDescription
mini Asthma Quality of Life Questionnaire (mini AQLQ)Recall over 2 week periodBased 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 TechnologyMeasured at 4 weeks after interventionUTAUT 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.

Other

MeasureTime frameDescription
Open Ended Questions for ASTHMAXcelED Application ImprovementMeasured at 4 weeks after interventionIn order to iteratively improve the app and develop themes regarding user adoption, participants will be asked the following open ended questions and their answers transcribed in their entirety. How do you feel about using the app? Have you run into any issues using the app? Is it getting easier/harder to use the app over time? Which app features do you like? Which app features do you dislike? Which app features do you find difficult to use? How can the app be improved?

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026