Recruiting

ASTHMAXcel Voice

Sponsor:

Montefiore Medical Center

Code:

NCT06935084

Conditions

Asthma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

ASTHMAXcel Voice platform

Study Details

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

Study ID

NCT06935084

Start date

Sep 18, 2025

Status verified date

Sep, 2026

Completion date

Sep, 2028

Anticipated

Primary completion date

Sep, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Design

Enrollment

200 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Health Services Research

Interventions and Outcome Measures

Arms

experimental: ASTHMAXcel

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

no intervention: Usual Care (UC)

Participants in this arm will receive standard care.

Interventions

ASTHMAXcel Voice platform

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.

Primary outcome measure

  • Change in Asthma Control [ Time Frame: Change from Baseline to 6 months after randomization ]

Central Contacts and Locations

Central contacts

Sunit Jariwala, MD

609-937-1023sjariwal@montefiore.org

Juliana D Rodriguez, MD

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

Locations

Montefiore Medical Center

Recruiting

The Bronx, New York, United States, 10467

Contacts

Sunit Jariwala, MD

609-937-1023sjariwal@montefiore.org

Juliana D Rodriguez, MD

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

More Information

Sponsor

Montefiore Medical Center

Last update posted

Sep 8, 2026

Last verified

Sep, 2026

Keywords

  • Mobile Health Application
  • Asthma Management
  • Asthma Control

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Montefiore Medical Center on 2026-09-08.