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AsthmaASTHMAXcelNCT05013073

ASTHMAXcel Emergency Department Study

A study testing ASTHMAXcel ED Application in people with Asthma and Asthma Attack, run by Montefiore Medical Center at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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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. Read more about this study

Who is it for?
Ages 18 to 100 years
Conditions the study is for
Asthma, Asthma Attack
What is being tested?
ASTHMAXcel ED Application
Could I receive a placebo?
No, everyone receives an active treatment
How many people
160 participants
Where
2 sitesUnited States
Study dates
1 May 2021to 7 Feb 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • English speakers
  • at least 18+ years old with
  • physician-diagnosed asthma.

Who cannot join

  • severe cognitive or psychiatric conditions precluding capacity to provide informed consent,
  • inability to speak English,
  • lacking the technology to access the app.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Montefiore Medical Center, Weiler Campus

    The Bronx, New York, 10461

  • Montefiore Medical Center, Moses Campus

    The Bronx, New York, 10467

Other trials in United States

About this study

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

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.

Read the 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.

Being tested
ASTHMAXcel ED Application
Medical subject headings
Asthma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ASTHMAXcel ED ApplicationOther

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

Study groups in NCT05013073
Study groupRoleWhat they receive
Experimental ArmExperimentalAll patients will be enrolled in a single arm and download the mobile application ASTHMAxcel ED to their smartphones.
Receives: Other: ASTHMAXcel ED Application

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Asthma Control Test (ACT)

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

    Measured: 4 Week Period

Secondary outcomes (2)

  1. 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.

    Measured: Recall over 2 week period

  2. 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: Measured at 4 weeks after intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Aug 2021
  2. Study start1 May 2021
  3. Primary completion7 Feb 2023
  4. Study completion7 Feb 2023

Why it stopped: IRB approval expired

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Model description
Single arm prospective open label study
Masking
None (open label)
Enrolment
160 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05013073
Sponsor's protocol ID
2021-12692
Acronym
ASTHMAXcel
Status last verified
Sep 2023
First submitted
6 Aug 2021
Last updated
21 Sep 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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

  • 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.

    PubMed 30390904

  • 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.

    PubMed 19675345

  • 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.

    PubMed 32487751

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

  • 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.

    PubMed 10489826

  • Oshlyansky, Lidia, Paul Cairns, and Harold Thimbleby.

Questions about this trial

What is this clinical trial studying?

A study testing ASTHMAXcel ED Application in people with Asthma and Asthma Attack, run by Montefiore Medical Center at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: IRB approval expired). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Asthma Control Test (ACT) (time frame: 4 Week Period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05013073, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.

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