Smartphone Application for Asthma Management

Overseen By Nataliya Kuzmin

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of South Florida

Disqualifiers: Mental disorder, Chronic lung disease, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a smartphone app can help teens manage their asthma more effectively. The app, called Asthma SMART, aims to make daily asthma care easier and more engaging. Participants will either continue with their regular asthma care or use the app alongside their usual treatment. Teens aged 12 to 17 with persistent asthma who speak English and have a smartphone may be suitable for this trial. The study aims to determine if the app is easy to use and beneficial for managing asthma symptoms. As an unphased trial, this study offers teens a unique opportunity to contribute to innovative asthma care solutions.

Will I have to stop taking my current medications?

The trial does not specify whether you need to stop taking your current medications. It seems you will continue with your standard asthma care while using the app.

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

Research shows that mobile health (mHealth) apps for managing asthma can be safe and helpful. Studies have found that these apps improve asthma control and lung function. They assist both patients and doctors by providing useful information for better asthma management.

While specific data on safety issues is lacking, mHealth apps are generally considered safe as they are digital tools, not medications. These apps support treatment by helping users track symptoms and medication use.

Overall, mHealth apps like Asthma SMART are promising tools for improving asthma management without posing direct safety concerns. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Asthma SMART app because it offers a novel approach to asthma management by leveraging digital technology. Unlike traditional treatments that might include inhalers or oral medications, this app empowers patients to actively monitor and manage their symptoms daily using their smartphones. The app aims to improve patient engagement and adherence to treatment plans, potentially leading to better asthma control and quality of life. By providing real-time feedback and personalized insights, it could revolutionize how patients interact with their healthcare, making asthma management more proactive and personalized.

What evidence suggests that this smartphone app is effective for asthma management?

Research shows that digital tools can help people manage asthma more effectively. One study found that adults using a digital asthma self-management program controlled their asthma better. Other studies have found that digital inhalers helped people adhere to their medication regimen, improving asthma control. These tools also assisted those who previously struggled with asthma management. In this trial, participants in the experimental arm will use the Asthma SMART app, which may offer similar benefits. While most research focuses on adults, teenagers using the Asthma SMART app might experience the same benefits. ^{1 5 6 7 8}

Who Is on the Research Team?

Amy Alman, PhD

Principal Investigator

University of South Florida

Marisa Couluris, DO

Principal Investigator

University of South Florida

Paul Rosen, PhD

Principal Investigator

University of Utah

Are You a Good Fit for This Trial?

This trial is for English-speaking adolescents aged 12-17 with mild to severe persistent asthma, who own an iPhone or Android device. They must be diagnosed by clinic physicians and live in the Tampa Bay area during the trial. It's not for those with other chronic lung diseases, certain disorders like cystic fibrosis, vision impairments that affect app use, mental or developmental disorders impacting self-management, or those involved in the app's development.

Inclusion Criteria

My asthma is persistent and has been confirmed by a doctor.

I am between 12 and 17 years old.

Must have a suitable iPhone or Android device available to use with the app

Exclusion Criteria

I have a chronic lung disease or a condition like cystic fibrosis, neuromuscular disease, an immune system disorder, or severe vision problems that could make it hard for me to use a mobile app.

You have a mental or developmental disorder that makes it hard for you to take care of a long-term health condition.

Having participated in the app development phase of the funded project

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants use the self-management app daily for asthma management in addition to standard-of-care

6 months

Daily app usage

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Asthma SMART

Trial Overview

The study tests a smartphone application designed to help teenagers manage their asthma better alongside standard care. Participants will either receive standard care alone or with the addition of this new app. The trial measures how well participants can stick to using the app and its impact on managing their asthma over six months.

How Is the Trial Designed?

Group I: Asthma SMART Experimental Treatment 1 Intervention

Subjects randomized to the intervention arm will be provided with the app to download to their personal iPhone or Android smartphone. Subjects will be asked to use the app every day for 6 months.

Group II: Standard of care Active Control 1 Intervention

Subjects randomized to the standard-of-care arm will continue to receive regular care for their condition.

Who Is Running the Clinical Trial?

University of South Florida

Lead Sponsor

Trials

433

Recruited

198,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

The number of asthma management apps more than doubled from 93 in 2011 to 191 in 2013, but many of these newer apps still lack comprehensive and evidence-based information, with only 13% providing supported self-care procedures.

Despite an increase in apps targeting specific skills like acute asthma management and inhaler technique, the overall quality remains low, with only 17% and 25% of these apps adhering to clinical guidelines and proper inhaler instructions, respectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The evolution of mobile apps for asthma: an updated systematic assessment of content and tools. Huckvale, K., Morrison, C., Ouyang, J., et al.[2022]

Asthma applications available on the Android platform primarily focus on helping patients with self-monitoring and self-assessment, which can lead to positive health outcomes for users across various demographics.

Despite their potential benefits, the quality of health information provided by these applications is generally low, indicating a need for improved content and ongoing evaluation of mHealth asthma applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A cross-sectional content analysis of Android applications for asthma. Househ, M., Hossain, N., Jamal, A., et al.[2018]

A review of 103 asthma apps revealed that only three provided comprehensive and reliable information about asthma, and none combined this with effective self-management tools, highlighting a significant gap in quality.

Many apps made unsupported recommendations for asthma management, and compliance with health information best practices was inconsistent, suggesting that healthcare professionals should be cautious when recommending these apps to patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Apps for asthma self-management: a systematic assessment of content and tools. Huckvale, K., Car, M., Morrison, C., et al.[2023]

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]

A study involving 111 asthma patients over 3 months revealed that users preferred apps with features like action plans, monitoring with feedback, and allergy/weather alerts to better manage their condition.

Healthcare professionals expressed interest in integrating patient data from these apps into practice records, but raised concerns about potential data overload and patient dependency on the technology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Time to change the paradigm? A mixed method study of the preferred and potential features of an asthma self-management app. Hui, CY., Walton, R., McKinstry, B., et al.[2021]

In 2018, there was a growing number of interactive mobile applications for allergy and asthma management available in the USA, indicating a trend towards digital health solutions in these areas.

These interactive asthma apps enhance communication between patients and healthcare providers, making personal health information and access to care more readily available, which can improve patient management and outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Asthma and Allergy Mobile Apps in 2018. Kagen, S., Garland, A.[2023]

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 systematic review included two randomized controlled trials with 408 participants, assessing the effectiveness of smartphone apps for asthma self-management compared to traditional methods, but the results were inconclusive due to low-quality evidence and significant variability between studies.

One study showed that a smartphone app improved asthma-related quality of life and lung function over six months, while the other found no significant impact on asthma symptoms or emergency visits, highlighting the need for further research to determine the true efficacy of these digital interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Smartphone and tablet self management apps for asthma. Marcano Belisario, JS., Huckvale, K., Greenfield, G., et al.[2022]

Clinicians believe that a mobile technology for asthma management can enhance patient care by providing real-time adherence data, particularly focusing on inhaler use and technique, which they find useful during clinic visits and for alerts on excessive rescue therapy use.

There are differing preferences between pediatric primary care clinicians and pulmonologists regarding the type of data they want from mobile health technology, highlighting the need for tailored solutions in asthma management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Understanding clinicians' attitudes toward a mobile health strategy to childhood asthma management: A qualitative study. Hollenbach, JP., Cushing, A., Melvin, E., et al.[2017]

Social media recruitment led to a higher number of downloads (87 users), but only 17% continued using the asthma management app for 30 days, indicating a challenge in maintaining long-term engagement.

In contrast, practice-based recruitment resulted in fewer downloads (24 patients), but a higher adherence rate of 54% over 30 days, suggesting that support from healthcare professionals significantly boosts ongoing app usage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A mixed method observational study of strategies to promote adoption and usage of an application to support asthma self-management. Hui, CY., McKinstry, B., Walton, R., et al.[2021]

A 3-month trial involving 20 adolescents showed that a tailored asthma app was functional and user-friendly, helping users manage their asthma by tracking their status and sending reminders for peak flow tests.

Participants reported that the app effectively supported their self-management skills, although they also identified external factors that limited its use and suggested improvements to enhance engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

I have most of my asthma under control and I know how my asthma acts: Users' perceptions of asthma self-management mobile app tailored for adolescents. Schneider, T., Baum, L., Amy, A., et al.[2021]

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 mobile health (mHealth) platform demonstrated an 80.10% accuracy in assessing asthma attack risk using physiological and environmental sensors, indicating its potential effectiveness for asthma self-management in children.

Usability testing showed that children could easily wear and understand the system, suggesting it could be a user-friendly tool for improving asthma management and potentially reducing hospitalizations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a Secure Wireless Sensing Smartwatch Application for the Self-Management of Pediatric Asthma. Hosseini, A., Buonocore, CM., Hashemzadeh, S., et al.[2019]

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