ASTHMAXcel Emergency Department Study

NCT ID: NCT05013073

Last Updated: 2023-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

160 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-05-01

Study Completion Date

2023-02-07

Brief Summary

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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

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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.

Conditions

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Asthma Asthma Attack

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Single arm prospective open label study
Primary Study Purpose

OTHER

Blinding Strategy

NONE

Open Label.

Study Groups

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Experimental Arm

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

Group Type EXPERIMENTAL

ASTHMAXcel ED Application

Intervention Type OTHER

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

Interventions

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ASTHMAXcel ED Application

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Montefiore Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Benjamin W Friedman, MD

Role: PRINCIPAL_INVESTIGATOR

Montefiore Medical Center

Locations

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Montefiore Medical Center, Weiler Campus

The Bronx, New York, United States

Site Status

Montefiore Medical Center, Moses Campus

The Bronx, New York, United States

Site Status

Countries

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United States

References

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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

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 30390904 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19675345 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32487751 (View on PubMed)

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

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 10489826 (View on PubMed)

Oshlyansky, Lidia, Paul Cairns, and Harold Thimbleby.

Reference Type BACKGROUND

Other Identifiers

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2021-12692

Identifier Type: -

Identifier Source: org_study_id

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