ASTHMAXcel Emergency Department Study

Sponsor
Montefiore Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05013073
Collaborator
(none)
110
2
1
28.1
55
2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: ASTHMAXcel ED Application
N/A

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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
110 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
Single arm prospective open label studySingle arm prospective open label study
Masking:
None (Open Label)
Masking Description:
Open Label.
Primary Purpose:
Other
Official Title:
Adapting the ASTHMAxcel ED Application to Improve Asthma Related Patient-Centered Outcomes and Health Care Resource Utilization
Actual Study Start Date :
May 1, 2021
Anticipated Primary Completion Date :
Sep 3, 2023
Anticipated Study Completion Date :
Sep 3, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Experimental Arm

All patients will be enrolled in a single arm and download the mobile application ASTHMAxcel ED to their smartphones.

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

Outcome Measures

Primary Outcome Measures

  1. Asthma Control Test (ACT) [4 Week Period]

    A patient self-administered tool for identifying those with poorly controlled asthma.

Secondary Outcome Measures

  1. 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.

  2. 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.

Other Outcome Measures

  1. Open Ended Questions for ASTHMAXcelED Application Improvement [Measured at 4 weeks after intervention]

    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?

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 100 Years
Sexes Eligible for Study:
All
Accepts 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Montefiore Medical Center, Weiler Campus Bronx New York United States 10461
2 Montefiore Medical Center, Moses Campus Bronx New York United States 10467

Sponsors and Collaborators

  • Montefiore Medical Center

Investigators

  • Principal Investigator: Benjamin W Friedman, MD, Montefiore Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Benjamin W. Friedman, MD, Professor, Montefiore Medical Center
ClinicalTrials.gov Identifier:
NCT05013073
Other Study ID Numbers:
  • 2021-12692
First Posted:
Aug 19, 2021
Last Update Posted:
Apr 27, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 27, 2022