ASTHMAXcel Voice Study

NCT06935084 | Recruiting

• 1 other identifier: 2025-16587
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to conduct a randomized controlled trial (RCT) to compare the adapted and refined ASTHMAXcel Voice platform to usual care (UC). It is hypothesized by the investigator team that ASTHMAXcel Voice will be associated with improved clinical and process outcomes, asthma quality of life (QOL), medication adherence, and self-efficacy as compared to UC.

Conditions

Asthma

Keywords

Mobile Health Application; Asthma Management; Asthma Control

Outcome Measures

Primary Outcomes (1)

• Change in Asthma Control

  Change in asthma control will be assessed and measured using the Asthma Control Test (ACT). The ACT is a 5-item questionnaire administered to assess asthma control. Participants will score each item on the ACT based on a 5-point Likert scale ranging from 1 (poor control) to 5 (excellent control) yielding an overall possible scoring range of 5-25, such that higher overall scores are associated with increased levels of asthma control. Change in ACT scores will be summarized by study arm using basic descriptive statistics. Paired t-tests will also be used to compare ACT scores between baseline and 2 months and baseline and 6 months within each arm.

  Change from Baseline to 6 months after randomization

Secondary Outcomes (14)

• Change in Asthma Control

  Change from Baseline to 2 months after randomization

• Change in User Acceptance of ASTHMAXcel Voice Application

  Baseline, 2 months, and 6 months after randomization

• Change in User Satisfaction of Interaction with the ASTHMAXcel Voice application

  Baseline, 2 months, and 6 months after randomization

• ASTHMAXcel Voice application Usage

  2 months and 6 months after randomization

• Change in Overall User Satisfaction

  Baseline, 2 months, and 6 months after randomization

Study Arms (2)

ASTHMAXcel

EXPERIMENTAL

Participants in this arm will be provided with the adapted and refined ASTHMAXcel Voice platform.

Other: ASTHMAXcel Voice platform

Usual Care (UC)

NO INTERVENTION

Participants in this arm will receive standard care.

Interventions

ASTHMAXcel Voice platform OTHER

ASTHMAXcel Voice is a mobile health application with a multi-level approach to address barriers with intervention components and facilitate health behavior change through the use of push notifications and interactive educational content.

ASTHMAXcel

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• English speaking
• Persistent asthma (diagnosed by a healthcare provider) on a daily controller medication
• Able to provide informed consent
• Smartphone access (iOS or Android) with data plan

You may not qualify if:

• Pregnancy
• Severe psychiatric or cognitive problems that would prohibit completion of protocol

Sponsors & Collaborators

• Montefiore Medical Center: lead
• Yeshiva University: collaborator
• Agency for Healthcare Research and Quality (AHRQ): collaborator

Study Sites (1)

Montefiore Medical Center

The Bronx, New York, 10467, United States

RECRUITING

Related Publications (19)

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  BACKGROUND

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  BACKGROUND

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  BACKGROUND

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  BACKGROUND

• Schatz M, Kosinski M, Yarlas AS, Hanlon J, Watson ME, Jhingran P. The minimally important difference of the Asthma Control Test. J Allergy Clin Immunol. 2009 Oct;124(4):719-23.e1. doi: 10.1016/j.jaci.2009.06.053. Epub 2009 Sep 19.

  PMID: 19767070 BACKGROUND

• 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.

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• Hsia B, Mowrey W, Keskin T, Wu S, Aita R, Kwak L, Ferastraoarou D, Rosenstreich D, Jariwala SP. Developing and pilot testing ASTHMAXcel, a mobile app for adults with asthma. J Asthma. 2021 Jun;58(6):834-847. doi: 10.1080/02770903.2020.1728770. Epub 2020 Feb 19.

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MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Sunit Jariwala, MD

  Montefiore Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sunit Jariwala, MD

CONTACT

609-937-1023; sjariwal@montefiore.org

Juliana D Rodriguez, MD

CONTACT

718-862-1722; juliana.rodríguez@einsteinmed.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Research assistants who administer questionnaires via the Electronic Data Capture (EDC) system will be blinded. Outcomes Assessors will not be blinded.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomized in a 1:1 ratio into one of two arms: ASTHMAXcel Voice or Usual Care (UC) arms. Block randomization (block size: 10) will be used for the purpose of balancing arms within each block. The randomization scheme will be prepared by the study statistician who will not be on study site.

Study Record Dates

• First Submitted: April 11, 2025
• First Posted: April 18, 2025
• Study Start: September 18, 2025
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): September 1, 2028
• Last Updated: October 24, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Results generated from this grant will be presented at national or international scientific meetings and conferences and will be published in a timely fashion. Data sets and associated documents will be provided to the NIH study Program Official within timelines described in the NIH Policy for Data Sharing from Observational Epidemiology Studies - no later than 3 years after the completion of each examination or follow-up cycle or 2 years after the baseline, follow-up, genetic, ancillary study, or other data set is finalized within the study for analysis for use in publication, whichever comes first. Study data will be made available to other users after publication of the study's main results have been published (estimated to be within 12 months of study closure). Once available, no time limit will be placed on accessibility of the study data.

Locations

US (1)