eAMS Smartphone App for Asthma

(eAMS Trial)

Not yet recruiting at 1 trial location

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Unity Health Toronto

Disqualifiers: Recent AAP, Pregnancy

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a smartphone app designed to help manage asthma. Patients fill out a simple questionnaire on their phones, which then provides doctors with recommendations for asthma care. Participants will also use a self-management tool called Breathe. The trial seeks individuals with asthma who have not received an asthma action plan in the last six months. As an unphased trial, this study offers a unique opportunity to contribute to innovative asthma management solutions.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems the focus is on using a smartphone app to manage asthma, so you may not need to change your current medication routine.

What prior data suggests that this app is safe for asthma management?

Research has shown that the Electronic Asthma Management System (eAMS) was tested in earlier studies with good results. This system manages asthma through a smartphone app where patients answer questions about their condition. Doctors then use the collected information to provide asthma care advice.

Although these studies did not provide specific safety data on eAMS, it's important to note that eAMS is an app. It doesn't involve taking new medicines or undergoing medical procedures, which usually reduces the risk of side effects. The main goal is to improve communication between patients and doctors about managing asthma.

Overall, available information suggests that eAMS is easy to use. It is a digital tool designed to enhance asthma care without introducing new medical risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The eAMS Smartphone App for Asthma is unique because it integrates technology into asthma management, offering a personalized approach through a smartphone or tablet app. Unlike traditional methods that rely on paper-based action plans and general guidelines, eAMS uses a simple questionnaire to generate tailored asthma care recommendations for clinicians. It also provides patients with a personalized asthma action plan and access to a tool called Breathe, empowering them to manage their condition more effectively. Researchers are excited about this treatment because it has the potential to enhance patient engagement and improve asthma outcomes by providing real-time, personalized care recommendations.

What evidence suggests that the eAMS app is effective for asthma management?

Research has shown that the Electronic Asthma Management System (eAMS), which participants in this trial may use, improves asthma care by using technology to assist in treatment decisions. Regular use of this digital asthma tool has reduced doctor visits and asthma flare-ups. The system includes a smartphone app that provides personalized asthma management plans, leading to better control of asthma symptoms. Studies also indicate that electronic devices for tracking asthma can reduce the need for rescue inhalers and enhance overall asthma management. These findings suggest that tools like eAMS make managing asthma more effective and convenient for patients. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for asthma patients aged 16 or older, identified by a validated electronic record search. It's open to those who haven't received an Asthma Action Plan (AAP) in the last six months. Pregnant individuals are excluded as AAP recommendations may differ for them.

Inclusion Criteria

Eligible physicians will include all primary care physicians at the 4 sites.

I am 16 or older with asthma confirmed by medical records.

Exclusion Criteria

Pregnant patients will be excluded given that conventional AAP recommendations may not be appropriate in this population.

I have been prescribed an AAP in the last 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants use the Electronic Asthma Management System (eAMS) to complete questionnaires and receive asthma care recommendations

12 months

Regular use of app and periodic clinical assessments

Follow-up

Participants are monitored for asthma control, medication changes, and healthcare utilization

12 months

What Are the Treatments Tested in This Trial?

Interventions

• eAMS

Trial Overview The study tests an Electronic Asthma Management System (eAMS). Patients use a smartphone app to complete questionnaires that help doctors assess asthma control and advise on medication changes, generating an electronic AAP based on responses.

How Is the Trial Designed?

Group I: Intervention Experimental Treatment 1 Intervention

Electronic Asthma Management System: eAMS Intervention eAMS consists of simple questionnaire completed either through an app on a patient's smartphone or tablet computer, a computerized clinical decision support system which then processes these data to produce a set of asthma care recommendations for the clinician, and a printable asthma action plan that is given to patients. eAMS will also provide access to a patient-oriented asthma management tool called Breathe.

Group II: Control Active Control 1 Intervention

Electronic Asthma Management System: eAMS - Control At control sites, eligible clinicians will be offered access to the web-based clinician-oriented asthma action plan (AAP) educational module produced by the Lung Association, copies of the Canadian Asthma Guidelines, and standard fillable paper-based AAPs (the eAMS will be offered after study end).

Who Is Running the Clinical Trial?

Unity Health Toronto

Lead Sponsor

Trials

572

Recruited

470,000+

Ontario Lung Association

Collaborator

Trials

20

Recruited

1,100+

Published Research Related to This Trial

A systematic review identified 6 mHealth apps that integrate with inhaler sensors, showing modest improvements in maintenance inhaler adherence and reduced use of rescue inhalers among asthma patients.

Despite these positive effects, the apps did not significantly impact overall asthma control or health outcomes, indicating a need for more comprehensive studies to evaluate their effectiveness in managing asthma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic Review of mHealth Applications That Interface with Inhaler Sensors in Asthma. Nguyen, E., Miao, B., Pugliese, N., et al.[2021]

A user-centered design approach was used to develop a prototype asthma smartphone application, incorporating feedback from patients and healthcare providers to ensure it meets their needs for effective self-management.

The review highlighted that only one existing asthma app utilized both user-centered design and intelligent learning systems, indicating a gap in the market for applications that can adapt and provide tailored support for asthma management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A user-centered, learning asthma smartphone application for patients and providers. Gaynor, M., Schneider, D., Seltzer, M., et al.[2022]

The developed mobile asthma management system includes a portable spirometer and a mobile app, designed to be affordable and user-friendly, enabling comprehensive asthma assessments.

This wireless solution meets the standards set by the American Thoracic Society and European Respiratory Society, aiming to enhance patient self-management and control of asthma in various settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrated Self-Management System for Improved Treatment of Asthma. Nguyen, KT., Culjat, MO., Mierzwa, AP., et al.[2018]

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. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6482383/

The Electronic Asthma Management System (eAMS) ... The Electronic Asthma Management System is a systematically developed and evidence-based computerised decision support tool that engages both patients and ...

2. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT03648203?term=teams%26draw=2%26rank=1

Technology Enabled Asthma Management System ... The overarching goal of TEAMS is to improve asthma outcomes by leveraging capabilities of existing technology (smartphone, telemedicine, electronic medical ...

3. publications.ersnet.org publications.ersnet.org/content/erj/50/suppl61/PA2778

Enabling asthma management and outcomes monitoring ... Abstract. Rationale: Electronic Medical Records (EMRs) can support and enable asthma management and outcomes monitoring, using standardized data elements.

4. bmcpulmmed.biomedcentral.com bmcpulmmed.biomedcentral.com/articles/10.1186/s12890-023-02467-8

Impact of a digital web-based asthma platform, a real-life study An interactive web-based asthma platform can reduce asthma-related health care visits and exacerbations when used actively.

5. sciencedirect.com sciencedirect.com/science/article/pii/S2213219822008285

Effectiveness of a Digital Inhaler System for Patients With ... The use of an electronic inhaler monitoring device has demonstrated reductions in SABA use, improved asthma control in previously uncontrolled patients, and ...

6. publications.ersnet.org publications.ersnet.org/content/erj/62/suppl67/pa4598

Outcomes-driven Asthma data application, Emirates Health ... The application highlights the latest disease status and care compliance gaps, as EHS policies recommend.All patients can be viewed in colour-segregated ...

7. clinicaltrials.gov clinicaltrials.gov/study/NCT03648203

Technology Enabled Asthma Management System ... It targets person level factors associated with asthma outcomes (individual knowledge, norms, attitudes, illness beliefs and self-efficacy), self-management ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S2213219825004088

Patient-Facing Digital Inhalers for Asthma: A Systematic ... Patient-facing digital inhalers probably improve asthma control and may reduce severe asthma exacerbations in patients at high risk for future exacerbations ...

9. academic.oup.com academic.oup.com/jamia/article/27/5/726/5817897

A point-of-care computerized clinical decision support system We sought to characterize system use, its predictors, and user feedback for the Electronic Asthma Management System (eAMS)—an electronic medical ...