NCT05013073

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P50-P75 for not_applicable asthma

Timeline
Completed

Started May 2021

Geographic Reach
1 country

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 6, 2021

Completed
13 days until next milestone

First Posted

Study publicly available on registry

August 19, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 7, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 7, 2023

Completed
Last Updated

September 21, 2023

Status Verified

September 1, 2023

Enrollment Period

1.8 years

First QC Date

August 6, 2021

Last Update Submit

September 18, 2023

Conditions

AsthmaAsthma Attack

Outcome Measures

Primary Outcomes (1)

  • Asthma Control Test (ACT)

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

    4 Week Period

Secondary Outcomes (2)

  • mini Asthma Quality of Life Questionnaire (mini AQLQ)

    Recall over 2 week period

  • Unified Theory of Acceptance and use of Technology

    Measured at 4 weeks after intervention

Other Outcomes (1)

  • Open Ended Questions for ASTHMAXcelED Application Improvement

    Measured at 4 weeks after intervention

Study Arms (1)

Experimental Arm

EXPERIMENTAL

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

Other: ASTHMAXcel ED Application

Interventions

ASTHMAXcel ED ApplicationOTHER

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

Experimental Arm

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Montefiore Medical Center, Weiler Campus

The Bronx, New York, 10461, United States

Location

Montefiore Medical Center, Moses Campus

The Bronx, New York, 10467, United States

Location

Related Publications (7)

  • 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

    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.

    PMID: 30390904BACKGROUND

  • 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.

    PMID: 19675345BACKGROUND

  • 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.

    PMID: 32487751BACKGROUND

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

    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.

    PMID: 10489826BACKGROUND

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

    BACKGROUND

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Benjamin W Friedman, MD

    Montefiore Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
Open Label.
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Single arm prospective open label study
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 6, 2021

First Posted

August 19, 2021

Study Start

May 1, 2021

Primary Completion

February 7, 2023

Study Completion

February 7, 2023

Last Updated

September 21, 2023

Record last verified: 2023-09

Data Sharing

IPD Sharing
Will not share

Locations

US(2)