ASTHMAXcel Emergency Department Study

Asthma Clinical Trial

— ASTHMAXcel  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05013073
• Other study ID #: 2021-12692
• Status: Terminated
• Phase: N/A
• Start date: May 1, 2021
• Est. completion date: February 7, 2023

Study information

• Verified date: September 2023
• Source: Montefiore Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 160
• Est. completion date: February 7, 2023
• Est. primary completion date: February 7, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Asthma
• Asthma Attack

Intervention

Other:
• ASTHMAXcel ED Application
A mobile application designed to assist patients in asthma symptom recognition, treatment best practices, and trigger identification.

Locations

Country	Name	City	State
United States	Montefiore Medical Center, Moses Campus	Bronx	New York
United States	Montefiore Medical Center, Weiler Campus	Bronx	New York

Sponsors (1)

Lead Sponsor	Collaborator
Montefiore Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (7)

"Asthma Control Test." Asthma Control Test (ACT), American Thoracic Society, www.thoracic.org/members/assemblies/assemblies/srn/questionaires/act.php

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. — View 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. — View 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. — View 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. — View Citation

Oshlyansky, Lidia, Paul Cairns, and Harold Thimbleby.

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Open Ended Questions for ASTHMAXcelED Application Improvement	In 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?	Measured at 4 weeks after intervention
Primary	Asthma Control Test (ACT)	A patient self-administered tool for identifying those with poorly controlled asthma.	4 Week Period
Secondary	mini Asthma Quality of Life Questionnaire (mini AQLQ)	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.	Recall over 2 week period
Secondary	Unified Theory of Acceptance and use of Technology	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.	Measured at 4 weeks after intervention