ASTHMAXcel Voice: a smartphone voice tool to help manage asthma
Conducting a Randomized Controlled Trial for A Novel Patient-Facing Mobile Platform to Collect and Implement Patient-Reported Outcomes and Voice Biomarkers in Underserved Adult Patients With Asthma
This project will test if the ASTHMAXcel Voice smartphone app, which uses a 6-second voice sample to detect worsening symptoms, helps people with persistent asthma improve control and self-management compared with usual care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Montefiore Medical Center Academic / other |
| Locations | 1 site (The Bronx, New York) |
| Trial ID | NCT06935084 on ClinicalTrials.gov |
What this trial studies
Researchers will run a randomized controlled trial comparing the adapted ASTHMAXcel Voice platform to usual care among English-speaking patients with persistent asthma on daily controller medication. The app combines patient-reported outcomes, educational videos, goal setting, personalized algorithms, push notifications, and a 6-second voice sample analyzed by machine learning to produce a Respiratory Symptoms Risk Score (RSRS). The platform also supports shared decision-making, screens for social determinants of health, enables referrals, and allows remote care coordination to promote medication adherence and self-management. Primary outcomes include clinical and process measures, asthma quality of life, medication adherence, and self-efficacy.
Who should consider this trial
Good fit: Ideal candidates are English-speaking patients with provider-diagnosed persistent asthma who take a daily controller medication, can provide informed consent, and own an iOS or Android smartphone with a data plan.
Not a fit: People who are pregnant, have severe psychiatric or cognitive impairments, do not speak English, or lack smartphone/data access are unlikely to benefit or be eligible.
Why it matters
Potential benefit: If successful, the app could reduce asthma exacerbations, emergency visits, and hospitalizations while improving quality of life and self-management, particularly for underserved patients.
How similar studies have performed: A prior AHRQ-funded pilot of ASTHMAXcel PRO showed significant reductions in steroid use, ED visits, and hospitalizations, but the voice-biomarker approach in ASTHMAXcel Voice is newer and less tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
The Bronx, New York
- Montefiore Medical Center — The Bronx, New York, United States (Recruiting)
Study contacts
- Principal investigator: Sunit Jariwala, MD — Montefiore Medical Center
- Study coordinator: Sunit Jariwala, MD
- Email: sjariwal@montefiore.org
- Phone: 609-937-1023
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.