ASTHMAXcel Voice for Asthma

Recruiting at 1 trial location

Overseen By Sunit Jariwala, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Montefiore Medical Center

Must be taking: Daily controller

Disqualifiers: Pregnancy, Severe psychiatric, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

200 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new tool called ASTHMAXcel Voice, which may help people with asthma manage their condition more effectively than standard care. The goal is to determine if this platform improves quality of life, medication adherence, and confidence in managing asthma symptoms. Participants will either use ASTHMAXcel Voice or continue with their usual asthma care. Suitable candidates have persistent asthma, use daily controller medication, and possess a smartphone with a data plan. As an unphased trial, this study provides a unique opportunity to contribute to innovative asthma management solutions.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, since it involves comparing a new platform to usual care, you might continue your current asthma medication.

What prior data suggests that the ASTHMAXcel Voice platform is safe for asthma patients?

Research has shown that the ASTHMAXcel Voice app helps manage asthma by analyzing voice samples. This technology uses a 6-second voice recording to assess asthma symptoms through machine learning. Studies suggest it can enhance asthma management and improve health outcomes.

For safety, patients contributed to the app's development, and medical experts reviewed it, indicating a focus on user safety. However, specific information about side effects or issues from using the ASTHMAXcel Voice app is not available. As a non-invasive app, it likely presents fewer safety concerns compared to traditional medication treatments. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the ASTHMAXcel Voice platform because it introduces a novel approach to managing asthma through voice interaction technology. Unlike traditional asthma treatments that typically involve inhalers or medication, ASTHMAXcel Voice aims to enhance patient engagement and self-management by providing personalized guidance and feedback via an interactive voice system. This innovative method could empower patients to better understand and control their condition, potentially leading to improved outcomes and a more active role in their own healthcare.

What evidence suggests that the ASTHMAXcel Voice platform is effective for asthma?

Research has shown that the ASTHMAXcel Voice platform, which participants in this trial may receive, helps control asthma symptoms and improve quality of life. Studies have found that this platform aids users in understanding their medication better and adhering to their treatment plan. Designed for ease of use, it effectively manages asthma daily. Users of ASTHMAXcel have reported better symptom control and an overall improvement in asthma-related quality of life. This suggests that ASTHMAXcel Voice can be a valuable tool for those seeking better asthma management. ^{1 2 5 6 7}

Who Is on the Research Team?

Sunit Jariwala, MD

Principal Investigator

Montefiore Medical Center

Are You a Good Fit for This Trial?

This trial is for individuals with asthma or allergies and asthma. Specific eligibility criteria are not provided, so it's important to contact the study team for details on who can participate.

Inclusion Criteria

Able to provide informed consent

Smartphone access (iOS or Android) with data plan

English speaking

Exclusion Criteria

Pregnancy

Severe psychiatric or cognitive problems that would prohibit completion of protocol

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the ASTHMAXcel Voice platform or receive usual care for asthma management

6 months

Monthly virtual check-ins

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 months

What Are the Treatments Tested in This Trial?

Interventions

• ASTHMAXcel Voice platform

Trial Overview The ASTHMAXcel Voice platform is being tested against usual care in a randomized controlled trial. The goal is to see if this platform improves outcomes like quality of life, medication adherence, and self-efficacy in asthma patients.

How Is the Trial Designed?

Group I: ASTHMAXcel Experimental Treatment 1 Intervention

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

Group II: Usual Care (UC) Active Control 1 Intervention

Participants in this arm will receive standard care.

Who Is Running the Clinical Trial?

Montefiore Medical Center

Lead Sponsor

Trials

468

Recruited

599,000+

Yeshiva University

Collaborator

Trials

13

Recruited

2,600+

Agency for Healthcare Research and Quality (AHRQ)

Collaborator

Trials

415

Recruited

6,777,000+

Published Research Related to This Trial

The ASTHMAXcel Adventures mobile app significantly improved asthma control in pediatric patients, with controlled asthma rates increasing from 30.8% at baseline to 59.0% at 6 months, particularly among boys.

Patients experienced reduced emergency department visits and oral prednisone use, with a decrease from 0.46 visits at baseline to 0.02 visits at 6 months, indicating better overall asthma management and high patient satisfaction throughout the study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Developing and evaluating ASTHMAXcel adventures: A novel gamified mobile application for pediatric patients with asthma. Hsia, BC., Singh, AK., Njeze, O., et al.[2020]

The ASTHMAXcel mobile application significantly improved asthma control and knowledge among adults, as evidenced by increased scores on the Asthma Control Test and Asthma Knowledge Questionnaire over 6 months.

Using ASTHMAXcel led to a notable reduction in asthma-related emergency department visits and hospitalizations, as well as decreased reliance on prednisone, highlighting its potential as an effective tool for outpatient asthma management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the ASTHMAXcel Mobile Application Regarding Asthma Knowledge and Clinical Outcomes. Hsia, BC., Wu, S., Mowrey, WB., et al.[2021]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06935084

Study Details | NCT06935084 | ASTHMAXcel Voice Study It is hypothesized by the investigator team that ASTHMAXcel Voice will be associated with improved clinical and process outcomes, asthma quality of life (QOL), ...

2. trialx.com trialx.com/clinical-trials/listings/325524/asthmaxcel-voice-study/?&geo_lat=40.9238&geo_lng=-73.9989&radius=10&place=Bergenfield&user_country=United%20States

ASTHMAXcel Voice Study | Clinical Research Trial Listing ... It is hypothesized by the investigator team that ASTHMAXcel Voice will be associated with improved clinical and process outcomes, asthma quality ...

3. jacionline.org jacionline.org/article/S0091-6749(23)02050-X/fulltext

Assessing Patient-Centered Clinical Outcomes in a Virtual ... Conclusions. The AsthmaXcel mobile platform is effective for significantly improving asthma symptom control and asthma quality of life and can contribute to ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40775888/

A Novel Mobile Health App for Asthma Management The results provide valuable insights into (1) perceived usefulness of ASTHMAXcel Voice particularly the new feature utilizing voice ...

5. liebertpub.com liebertpub.com/doi/10.1089/respcare.12312

Implementing and Evaluating the Clinical Outcomes of an ... We previously demonstrated that the ASTHMAXcel mobile platform can improve asthma control, knowledge, and quality of life, as well as reduce ...

6. digital.ahrq.gov digital.ahrq.gov/program-overview/research-stories/asthmaxcel-voice-mobile-application-improve-chronic-disease

ASTHMAXcel Voice Mobile Application to Improve Chronic ... A mobile app that uses voice biomarkers to assess asthma symptoms has the potential to improve self-management, shared decision making, and health outcomes ...

7. tandfonline.com tandfonline.com/doi/full/10.1080/02770903.2020.1728770

Developing and pilot testing ASTHMAXcel, a mobile app ... ASTHMAXcel was designed based on patient feedback and consistent with NAEPP, BTS/SIGN, and GINA guidelines. The app was reviewed by internists, allergist/ ...