Clinical trial NCT05013073: ASTHMAXcel Emergency Department Study
Official title: Adapting the ASTHMAxcel ED Application to Improve Asthma Related Patient-Centered Outcomes and Health Care Resource Utilization
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Asthma
Asthma Attack
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2021-08-19
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Single arm prospective open label study
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Asthma Control Test (ACT)
timeFrame: 4 Week Period
Secondary outcomes:
measure: mini Asthma Quality of Life Questionnaire (mini AQLQ)
timeFrame: Recall over 2 week period
measure: Unified Theory of Acceptance and use of Technology
timeFrame: Measured at 4 weeks after intervention
Other outcomes:
measure: Open Ended Questions for ASTHMAXcelED Application Improvement
timeFrame: Measured at 4 weeks after intervention
Locations:
city: Bronx
country: United States
facility: Montefiore Medical Center, Weiler Campus
state: New York
city: Bronx
country: United States
facility: Montefiore Medical Center, Moses Campus
state: New York
Study officials:
affiliation: Montefiore Medical Center
name: Benjamin W Friedman, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rui, P., & Kang, K. (2014). National Hospital Ambulatory Medical Care Survey: 2014 Emergency Department Summary Tables. Retrieved from http://www.cdc.gov/nchs /data/ahcd/nhamcs_emergency/2014 _ed_web_tables.pdf
citation: Gerald JK, Denninghoff KR. Emergency Department Recidivism and Asthma: Revisiting an Old Problem. J Allergy Clin Immunol Pract. 2018 Nov-Dec;6(6):1914-1915. doi: 10.1016/j.jaip.2018.06.006. No abstract available.
citation: Camargo CA Jr, Rachelefsky G, Schatz M. Managing asthma exacerbations in the emergency department: summary of the National Asthma Education And Prevention Program Expert Panel Report 3 guidelines for the management of asthma exacerbations. Proc Am Thorac Soc. 2009 Aug 1;6(4):357-66. doi: 10.1513/pats.P09ST2. No abstract available.
citation: Hsia BC, Wu S, Mowrey WB, Jariwala SP. Evaluating the ASTHMAXcel Mobile Application Regarding Asthma Knowledge and Clinical Outcomes. Respir Care. 2020 Aug;65(8):1112-1119. doi: 10.4187/respcare.07550. Epub 2020 Jun 2.
citation: "Asthma Control Test." Asthma Control Test (ACT), American Thoracic Society, www.thoracic.org/members/assemblies/assemblies/srn/questionaires/act.php
citation: Juniper EF, Guyatt GH, Cox FM, Ferrie PJ, King DR. Development and validation of the Mini Asthma Quality of Life Questionnaire. Eur Respir J. 1999 Jul;14(1):32-8. doi: 10.1034/j.1399-3003.1999.14a08.x.
citation: Oshlyansky, Lidia, Paul Cairns, and Harold Thimbleby.