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

Trial Summary

What is the purpose of this trial?

The primary goal of this project is to determine the feasibility, acceptability, and adherence of a smartphone application for improving asthma self-management in a pilot randomized controlled trial (RCT). The app is specifically designed to appeal to adolescents. Adolescents with persistent asthma will be randomized to receive: 1) standard-of-care or 2) the self-management app in addition to standard-of-care. Feasibility will be assessed by the ability to recruit and retain subjects, technical barriers to implementation, and the appropriateness of the intervention among adolescents and providers. The acceptability of the intervention will be determined by appraising perceived usefulness, entertainment, and ease of use of the app. Adherence to usage of the app over a 6-month period will be assessed by examining the frequency of app usage and the features that were used, and the extent of data regarding self-management that was entered. A secondary objective is to obtain preliminary estimates of effectiveness of the app on clinical outcomes (ACT score, spirometry, CHSA-C, exacerbations, and medication adherence) relative to standard-of-care. It is hypothesized that the app will result in a high level of adherence and will be a feasible and acceptable intervention to improve self-management among adolescents with persistent asthma.

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 data supports the effectiveness of the treatment Asthma SMART, Asthma Self-Management Apps, Asthma SMART Systems for asthma management?

Research shows that self-management programs, which can be delivered through smartphone apps, are recommended by major clinical guidelines and have been associated with improved outcomes for asthma patients. These apps offer customizable, low-cost, and accessible ways to support asthma management, potentially improving patient adherence and outcomes. ^{1 2 3 4 5}

Is the Smartphone Application for Asthma Management safe for humans?

Research on asthma management apps, including those using smartwatch technology, suggests they are generally safe for users. These apps have been tested for usability and functionality, showing positive outcomes in self-management and education without reported safety concerns. ^{5 6 7 8 9}

How is the Asthma SMART treatment different from other asthma treatments?

Asthma SMART is unique because it uses a smartphone app designed to help patients manage their asthma by providing personalized, user-centered tools and information. Unlike traditional treatments, it includes a wireless spirometer (a device to measure lung function) that helps patients self-assess their condition, making it easier to manage asthma at home or on the go. ^{7 10 11 12 13}

Research Team

Marisa Couluris, DO

Principal Investigator

University of South Florida

Paul Rosen, PhD

Principal Investigator

University of Utah

Amy Alman, PhD

Principal Investigator

University of South Florida

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

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]

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 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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Apps for asthma self-management: a systematic assessment of content and tools. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Smartphone and tablet self management apps for asthma. [2022]

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

Understanding clinicians' attitudes toward a mobile health strategy to childhood asthma management: A qualitative study. [2017]

4. England 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. [2021]

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

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

6. Switzerland pubmed.ncbi.nlm.nih.gov

Feasibility of a Secure Wireless Sensing Smartwatch Application for the Self-Management of Pediatric Asthma. [2019]

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

The evolution of mobile apps for asthma: an updated systematic assessment of content and tools. [2022]

8. England 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. [2021]

9. England pubmed.ncbi.nlm.nih.gov

A cross-sectional content analysis of Android applications for asthma. [2018]

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

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

11. Netherlands pubmed.ncbi.nlm.nih.gov

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

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

Asthma and Allergy Mobile Apps in 2018. [2023]

13. England 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. [2021]