ASTHMAXcel Voice for Asthma

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

Trial Summary

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 data supports the effectiveness of the ASTHMAXcel Voice treatment for asthma?

Research shows that the ASTHMAXcel mobile application, which is part of the ASTHMAXcel Voice platform, has been linked to improved asthma knowledge, control, and quality of life among adults with asthma. This suggests that the ASTHMAXcel Voice treatment may also be effective in helping patients manage their asthma better. ^{1 2 3 4 5}

Is ASTHMAXcel Voice safe for humans?

The ASTHMAXcel mobile application has been used in studies with adults and children with asthma, and there have been no reports of safety concerns or adverse effects in these studies. ^{1 3 6 7 8}

How is the ASTHMAXcel Voice treatment different from other asthma treatments?

ASTHMAXcel Voice is unique because it is a mobile health platform designed to improve asthma management through digital education and support, rather than traditional medication. It focuses on enhancing asthma knowledge and self-management, offering a novel approach compared to standard drug treatments. ^{1 3 4 7 9}

What is the purpose of this trial?

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.

Research Team

Sunit Jariwala, MD

Principal Investigator

Montefiore Medical Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Developing and evaluating ASTHMAXcel adventures: A novel gamified mobile application for pediatric patients with asthma. [2020]

2. United States pubmed.ncbi.nlm.nih.gov

Severe Asthma Global Evaluation (SAGE): An Electronic Platform for Severe Asthma. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Evaluating the effect and user satisfaction of an adapted and translated mobile health application ASTHMAXcel© among adults with asthma in Pune, India. [2023]

4. Canada pubmed.ncbi.nlm.nih.gov

A Smartphone App to Support Adherence to Inhaled Corticosteroids in Young Adults With Asthma: Multi-Methods Feasibility Study. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Assessing the impact of a remote digital coaching engagement program on patient-reported outcomes in asthma. [2019]

6. India pubmed.ncbi.nlm.nih.gov

Improving quality of life in asthmatic children. [2019]

7. England pubmed.ncbi.nlm.nih.gov

Developing and pilot testing ASTHMAXcel, a mobile app for adults with asthma. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Evaluating the ASTHMAXcel Mobile Application Regarding Asthma Knowledge and Clinical Outcomes. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

Energy Efficient Monitoring of Metered Dose Inhaler Usage. [2018]