eAMS Smartphone App for Asthma

(eAMS Trial)

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

50 Participants Needed

Trial Summary

What is the purpose of this trial?

This study is an extension of a pilot study in which investigators developed and tested a computerized tool to help physicians to determine if their patients' asthma is well controlled, advise them on medication changes required according to the current level of control, and automatically generate an electronic version of the AAP, all based on patient responses to a questionnaire completed by patients on a tablet computer. In this phase patients will have the ability to complete the questionnaire on their smartphones, through a pre-downloaded app and will have access to an electronic asthma self-management app.

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 data supports the effectiveness of the eAMS treatment for asthma?

Research shows that mobile apps and technology-based interventions can help people manage asthma better by improving education, monitoring symptoms, and ensuring they take their medication as prescribed. These tools empower patients to manage their asthma more effectively at home and in daily life. ^{1 2 3 4 5}

How does the eAMS Smartphone App for Asthma differ from other asthma treatments?

The eAMS Smartphone App for Asthma is unique because it integrates a mobile application with a portable spirometer (a device that measures lung function) to help patients self-manage their asthma. This approach empowers patients to monitor their condition more accurately at home, which can lead to better asthma control and improved quality of life compared to traditional treatments. ^{1 2 6 7 8}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Integrated Self-Management System for Improved Treatment of Asthma. [2018]

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

Systematic Review of mHealth Applications That Interface with Inhaler Sensors in Asthma. [2021]

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

Impact of Technology-Based Interventions on Patient-Reported Outcomes in Asthma: A Systematic Review. [2021]

4. Italy pubmed.ncbi.nlm.nih.gov

Opinions of patients with persistent asthma regarding the use of mobile applications for disease monitoring. [2022]

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

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

6. Germany pubmed.ncbi.nlm.nih.gov

Patient Self-Management of Asthma Using Mobile Health Applications: A Systematic Review of the Functionalities and Effects. [2018]

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

A user-centered, learning asthma smartphone application for patients and providers. [2022]

8. 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]