ASTHMAXcel Emergency Department Study (ASTHMAXcel)
Primary Purpose
Asthma, Asthma Attack
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ASTHMAXcel ED Application
Sponsored by

About this trial
This is an interventional other trial for Asthma
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.
Sites / Locations
- Montefiore Medical Center, Weiler Campus
- Montefiore Medical Center, Moses Campus
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Experimental Arm
Arm Description
All patients will be enrolled in a single arm and download the mobile application ASTHMAxcel ED to their smartphones.
Outcomes
Primary Outcome Measures
Asthma Control Test (ACT)
A patient self-administered tool for identifying those with poorly controlled asthma.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT05013073
First Posted
August 6, 2021
Last Updated
September 18, 2023
Sponsor
Montefiore Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT05013073
Brief Title
ASTHMAXcel Emergency Department Study
Acronym
ASTHMAXcel
Official Title
Adapting the ASTHMAxcel ED Application to Improve Asthma Related Patient-Centered Outcomes and Health Care Resource Utilization
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Terminated
Why Stopped
IRB approval expired
Study Start Date
May 1, 2021 (Actual)
Primary Completion Date
February 7, 2023 (Actual)
Study Completion Date
February 7, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Montefiore Medical Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, Asthma Attack
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Single arm prospective open label study
Masking
None (Open Label)
Masking Description
Open Label.
Allocation
N/A
Enrollment
160 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental Arm
Arm Type
Experimental
Arm Description
All patients will be enrolled in a single arm and download the mobile application ASTHMAxcel ED to their smartphones.
Intervention Type
Other
Intervention Name(s)
ASTHMAXcel ED Application
Intervention Description
A mobile application designed to assist patients in asthma symptom recognition, treatment best practices, and trigger identification.
Primary Outcome Measure Information:
Title
Asthma Control Test (ACT)
Description
A patient self-administered tool for identifying those with poorly controlled asthma.
Time Frame
4 Week Period
Secondary Outcome Measure Information:
Title
mini Asthma Quality of Life Questionnaire (mini AQLQ)
Description
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.
Time Frame
Recall over 2 week period
Title
Unified Theory of Acceptance and use of Technology
Description
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.
Time Frame
Measured at 4 weeks after intervention
Other Pre-specified Outcome Measures:
Title
Open Ended Questions for ASTHMAXcelED Application Improvement
Description
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?
Time Frame
Measured at 4 weeks after intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benjamin W Friedman, MD
Organizational Affiliation
Montefiore Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montefiore Medical Center, Weiler Campus
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Montefiore Medical Center, Moses Campus
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
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
Results Reference
background
PubMed Identifier
30390904
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.
Results Reference
background
PubMed Identifier
19675345
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.
Results Reference
background
PubMed Identifier
32487751
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.
Results Reference
background
Citation
"Asthma Control Test." Asthma Control Test (ACT), American Thoracic Society, www.thoracic.org/members/assemblies/assemblies/srn/questionaires/act.php
Results Reference
background
PubMed Identifier
10489826
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.
Results Reference
background
Citation
Oshlyansky, Lidia, Paul Cairns, and Harold Thimbleby.
Results Reference
background
Learn more about this trial
ASTHMAXcel Emergency Department Study
We'll reach out to this number within 24 hrs