Asthma Management App for Asthma

(PEAKmAAP Trial)

Overseen By Rita C. Hudson Brown, BA

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Arkansas Children's Hospital Research Institute

Must be taking: Asthma controllers

Disqualifiers: Cystic fibrosis, Developmental delay, Smoker, others

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

Compensation: Varies

Number of Visits: 2

Duration: 12 months

370 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

The goal of this research study is to test how good an app is in making asthma easier to manage for 372 adolescents/young adults. The app is a mobile version of the asthma action plan.

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 likely that you can continue your prescribed asthma medication, as the study focuses on using an app to manage asthma.

Is the Asthma Management App safe for use in humans?

There is no specific safety data available for the Asthma Management App under the names NutriMap Usual Care, PEAKmAAP, or PEAKmAAP-DS. However, general concerns about mobile health apps include issues with privacy, security, and data accuracy, which are important for ensuring user safety. ^{1 2 3 4 5}

How does the Asthma Management App treatment differ from other asthma treatments?

The Asthma Management App treatment is unique because it uses a mobile application to help manage asthma, focusing on improving adherence to treatment and providing self-management tools. This approach is different from traditional treatments as it leverages technology to enhance patient engagement and control over their condition. ^{1 5 6 7 8}

What data supports the effectiveness of the treatment NutriMap Usual Care, PEAKmAAP, PEAKmAAP-DS for asthma management?

Research shows that mobile health apps can improve asthma control and quality of life by helping patients manage their condition better. These apps often include features like reminders and educational information, which can support self-management and potentially reduce hospital visits. ^{1 6 9 10 11}

Who Is on the Research Team?

Tamara T. Perry, MD

Principal Investigator

University of Arkansas

Are You a Good Fit for This Trial?

This trial is for adolescents and young adults aged 12 to under 21 with persistent asthma, as defined by national guidelines. They must have an ACT score of 19 or less, been prescribed asthma controller medication in the last six months, and have access to a smartphone and internet. It's not for those with other significant respiratory diseases besides asthma, severe co-morbid conditions that could affect self-monitoring, participants in recent clinical trials on asthma, or current smokers.

Inclusion Criteria

Access to the internet

I am between 12 and 20 years old.

I have been diagnosed with long-term asthma.

Exclusion Criteria

I have a health condition that could make it hard for me to manage my asthma on my own.

You are currently smoking.

You have participated in an asthma clinical trial in the last 6 months.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants use the PEAKmAAP app to manage asthma, with daily symptom logging and medication reminders

12 months

Monthly virtual check-ins

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• NutriMap Usual Care
• PEAKmAAP
• PEAKmAAP-DS

Trial Overview The study tests a mobile app designed to help manage asthma more effectively among high-risk patients. The app is based on the traditional written asthma action plan but optimized for smartphones. Participants will be divided into groups: one using the standard care NutriMap app and others using different versions of the PEAKmAAP app.

How Is the Trial Designed?

Group I: PEAKmAAP-Data Sharing (DS) Experimental Treatment 1 Intervention

PEAKmAAP with Data Sharing (PEAKmAAP-DS) group will be asked to enter asthma symptoms or peak flow every day. The PEAKmAAP guides participants when to take asthma medicines and sends reminders to take their medicines every day. PEAKmAAP also provides reminders when to get asthma medicines refilled. Asthma education messages and video links are also pushed via notification. The primary care provided (PCP) will receive monthly reports to help them know how the participant's asthma symptoms are over time.

Group II: PEAKmAAP Experimental Treatment 1 Intervention

The Pulmonary Education and Asthma Knowledge mobile asthma action plan (PEAKmAAP) group will use a mobile "app" that will help manage asthma. Participants will be asked to enter asthma symptoms or peak flow every day. The PEAKmAAP guides participants when to take asthma medicines and sends reminders to take their medicines every day. mAAP also provides reminders when to get asthma medicines refilled. Asthma education messages and video links are also pushed via notification.

Group III: Nutrition Map (NutriMap) Usual Care Experimental Treatment 1 Intervention

Participants in this arm will use a smartphone application that sends daily non-asthma-related reminder for attention control. Participants will be asked to log their daily fruits and vegetables eaten. Participants will answer survey questions about their asthma and symptoms management.

Who Is Running the Clinical Trial?

Arkansas Children's Hospital Research Institute

Lead Sponsor

Trials

141

Recruited

5,025,000+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

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]

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]

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]

Many mobile health apps, including insulin dose calculators and asthma management tools, have significant methodological weaknesses, such as poor user input validation and inappropriate recommendations, which can compromise patient safety.

A review of health apps revealed serious privacy and security issues, with 28% lacking a privacy policy and some transmitting personal data, highlighting the need for better regulation and transparency in app development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

'Trust but verify'--five approaches to ensure safe medical apps. Wicks, P., Chiauzzi, E.[2022]

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]

Citations

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

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

2. Italy pubmed.ncbi.nlm.nih.gov

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

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

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

4. Germany pubmed.ncbi.nlm.nih.gov

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

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

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

6. England pubmed.ncbi.nlm.nih.gov

'Trust but verify'--five approaches to ensure safe medical apps. [2022]

7. Switzerland pubmed.ncbi.nlm.nih.gov

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

8. England pubmed.ncbi.nlm.nih.gov

Promising peak flow diary compliance with an electronic peak flow meter and linked smartphone app. [2021]

9. 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]

10. Canada pubmed.ncbi.nlm.nih.gov

Quantitative and qualitative usage data of an Internet-based asthma monitoring tool. [2018]

11. England pubmed.ncbi.nlm.nih.gov

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