SMART@Home Digital Platform for Asthma Management

Overseen By Kevin Hommel, PhD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Children's Hospital Medical Center, Cincinnati

Disqualifiers: Pervasive developmental disorder, Serious mental illness

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

Compensation: Varies

Number of Visits: Unknown

25 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new digital tool, SMART@Home, designed to manage asthma more effectively. The goal is to determine if the app, which integrates with devices like spirometers (tools that measure lung function), can better track symptoms and guide treatment decisions. Participants will either use the app or continue with their usual care to compare outcomes. The trial seeks adolescents aged 12-17 who regularly experience asthma symptoms. It aims to enhance connectivity and engagement in asthma care through this innovative platform. As an unphased trial, participants can contribute to pioneering research that may transform asthma management for young people.

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 focused on testing a digital platform for asthma management, so it's likely you can continue your usual treatment, but please confirm with the trial coordinators.

What prior data suggests that the SMART@Home platform is safe for asthma management?

Research shows that digital health tools like SMART@Home can safely and effectively manage asthma. Studies indicate that mobile apps paired with devices like digital inhalers improve asthma control and reduce severe attacks. These digital tools simplify asthma management at home.

SMART@Home employs mobile apps and sensors to track symptoms and medication use, offering real-time monitoring and feedback. Users have found these apps safe and easy to use. Similar digital health tools have reported no major safety issues.

As a digital platform, SMART@Home primarily complements existing asthma treatments, posing no direct risk of physical harm like some medications or procedures. Overall, the SMART@Home platform appears promising for safe and effective asthma management. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the SMART@Home digital platform because it brings a fresh approach to asthma management by integrating technology into daily care. Unlike traditional treatments that rely on medication alone, SMART@Home uses an app to help patients track their medication and symptoms while also providing real-time feedback on lung function through spirometry. This digital tool aims to empower patients with more personalized data, potentially improving their ability to manage asthma more effectively. By offering a comprehensive and interactive way to monitor asthma, SMART@Home could lead to better health outcomes and more proactive management of the condition.

What evidence suggests that the SMART@Home platform is effective for asthma management?

Research shows that digital tools like SMART@Home, available to participants in this trial, can help people with asthma manage their symptoms more effectively. Studies have found that similar health apps can improve asthma control and may reduce severe attacks. The SMART@Home platform connects with devices to provide real-time information on asthma activity and integrates with electronic health records, aiding doctors in making better treatment decisions. By tracking symptoms, medication use, and lung function, the app guides users to take action when needed. Early evidence suggests that these digital methods can enhance asthma care by offering timely assistance. ^{2 3 5 6 7}

Who Is on the Research Team?

Kevin Hommel, PhD

Principal Investigator

Children's Hospital Medical Center, Cincinnati

Rachelle Ramsey, PhD

Principal Investigator

Children's Hospital Medical Center, Cincinnati

Matt Wortman, PhD

Principal Investigator

Children's Hospital Medical Center, Cincinnati

Are You a Good Fit for This Trial?

This trial is for young people aged 11-17 with asthma who need regular treatment. They and their caregivers must speak English fluently. It's not open to those with developmental disorders or serious mental illnesses like schizophrenia, as noted in medical records.

Inclusion Criteria

English fluency for patient and caregiver

I am between 11 and 17 years old.

I have a chronic condition like asthma that needs regular treatment.

Exclusion Criteria

Diagnosis of pervasive developmental disorder in patient or caregiver as determined by medical chart review

Diagnosis of serious mental illness (e.g., schizophrenia) in patient or caregiver as determined by medical chart review

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Beta Testing

Beta test of the SMART@Home Asthma Tracker and asthma action plan algorithm with approximately 8 participants, recording simulated increases in symptoms

4 weeks

Pilot Randomized Control Trial (RCT)

6-month pilot RCT with 40 adolescent patients with asthma, testing the interactive asthma action plan functionality and impact

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• SMART@Home

Trial Overview The SMART@Home feasibility trial is testing a digital platform designed to help manage complex patient care remotely. It includes an app that connects to Bluetooth devices for tracking asthma and integrates with the Epic health record system.

How Is the Trial Designed?

Group I: SMART@Home Experimental Treatment 1 Intervention

Use of the SMART@Home app for medication and symptom tracking, spirometry feedback

Group II: Control Active Control 1 Intervention

Usual Care

Who Is Running the Clinical Trial?

Children's Hospital Medical Center, Cincinnati

Lead Sponsor

Trials

844

Recruited

6,566,000+

Published Research Related to This Trial

A comprehensive analysis of 372,345 spontaneous reports from 2011 to 2017 identified 385 different safety signals related to asthma medications in children, with a notable focus on psychiatric events, highlighting the importance of monitoring these drugs in the pediatric population.

The study uncovered new safety signals, such as herpes viral infections linked to omalizumab and hypertrichosis associated with budesonide, emphasizing that age stratification is crucial for detecting unique risks in children that may not be evident in the broader population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Exploratory Study of Signals for Asthma Drugs in Children, Using the EudraVigilance Database of Spontaneous Reports. Baan, EJ., de Smet, VA., Hoeve, CE., et al.[2021]

A review of 99 completed allergic rhinitis trials found that while adverse events (AEs) were fully reported in ClinicalTrials.gov, only 46.7% of corresponding publications provided complete AE reporting, highlighting a significant gap in transparency.

Inconsistencies were prevalent in 95.6% of the publications, with discrepancies in the number and types of AEs reported, indicating a need for improved reporting standards to enhance patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reporting of the safety from allergic rhinitis trials registered on ClinicalTrials.gov and in publications: An observational study. Paladin, I., Pranić, SM.[2022]

From 2000 to 2016, the incidence of adverse drug events related to anti-asthmatic medications in hospitalized children increased significantly, from 5.3 to 21.6 per 1000 discharges, indicating a growing concern for safety in pediatric asthma treatment.

Children aged 0-4 years experienced the most dramatic rise in adverse events from bronchodilators, highlighting the need for careful monitoring and management of asthma medications in this vulnerable age group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Drug Events Related to Common Asthma Medications in US Hospitalized Children, 2000-2016. Xie, L., Gelfand, A., Mathew, MS., et al.[2022]

The eAsthmaCare platform was developed to support asthmatic children and their families in managing asthma through a web-based self-management system, which includes features like an online asthma diary and remote assessments.

In a study involving 41 asthmatic children and their parents, the system demonstrated acceptable satisfaction scores across multiple domains, indicating its feasibility and potential to improve communication between patients and healthcare professionals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of online diary and self-management system on e-Healthcare for asthmatic children in Taiwan. Lin, HC., Chiang, LC., Wen, TN., et al.[2014]

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 BREATHE platform is a mobile health framework that integrates various sensors to monitor pediatric asthma, collecting continuous data on health metrics, environmental exposures, and daily activities from 20 participants over a week.

Initial findings suggest that BREATHE can effectively correlate environmental triggers with asthma symptoms, although usability challenges were noted, indicating the need for improvements in user engagement and convenience.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biomedical REAl-Time Health Evaluation (BREATHE): toward an mHealth informatics platform. Bui, AAT., Hosseini, A., Rocchio, R., et al.[2022]

The proposed three-part framework for analyzing adverse events includes phases for documenting incidents, conducting in-depth reviews, and assessing the association between exposure and adverse events, which can enhance product safety.

By standardizing the evaluation of adverse events through this framework, companies can better manage risks and improve consumer products based on reliable data.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Post-market surveillance of consumer products: Framework for adverse event management. Kingston, R., Sioris, K., Gualtieri, J., et al.[2022]

The connected-for-asthma system (C4A) was found to be user-friendly and effective in helping patients self-manage their asthma, with 8 out of 10 participants wanting to continue using it after the study.

Patients valued the accuracy of the devices and used them to monitor symptoms and medication, highlighting the importance of trust in technology for effective asthma management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing the technical feasibility of a flexible, integrated Internet-of-things connected for asthma (C4A) system to support self-management: a mixed method study exploring patients and healthcare professionals perspectives. Hui, CY., McKinstry, B., Mclean, S., et al.[2023]

In a study involving 288 participants with poorly controlled asthma, mobile phone-based monitoring did not show significant improvements in asthma control or self-efficacy compared to traditional paper-based monitoring after six months.

Both monitoring methods resulted in similar rates of acute exacerbations and healthcare costs, but the mobile phone service was more expensive due to telemonitoring costs, making it not cost-effective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical and cost effectiveness of mobile phone supported self monitoring of asthma: multicentre randomised controlled trial. Ryan, D., Price, D., Musgrave, SD., et al.[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]

The study introduces a cloud-based wearable IoT aldehyde sensor system designed to monitor environmental factors that can trigger asthma, potentially improving asthma management.

This innovative sensor system allows for real-time data collection and analysis, which can help researchers and patients better understand and manage asthma triggers in their daily environments.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Wearable IoT Aldehyde Sensor for Pediatric Asthma Research and Management. Li, B., Dong, Q., Downen, RS., et al.[2020]

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 a survey of 1,351 asthma patients aged 18-50, nearly 59% reported adverse events (AEs) related to their asthma therapy, with tiredness and palpitations being the most common symptoms.

Patients with poor asthma control and those who perceive their asthma as a handicap were significantly more likely to report multiple AEs, suggesting that better education and management of asthma could improve treatment acceptability and reduce reported side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient-reported adverse events under asthma therapy: a community pharmacy-based survey. Laforest, L., Van Ganse, E., Devouassoux, G., et al.[2015]

Citations

1. withpower.com withpower.com/trial/phase-asthma-in-children-2024-c472c

SMART@Home Digital Platform for Asthma Management The SMART@Home Digital Platform is unique because it integrates digital tools like mobile apps and wearable sensors to help patients manage asthma at home.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11091812/

Digital Self-Management Platform for Adult Asthma This is a digital health app that aims to support people with asthma by combining numerous approaches that have been shown as effective in ...

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

Patient-Facing Digital Inhalers for Asthma: A Systematic ... The findings that patient-facing digital inhalers probably improve asthma symptom control and may reduce severe asthma exacerbations in high- ...

4. thelancet.com thelancet.com/journals/eclinm/article/PIIS2589-5370(25)00136-1/fulltext

Digitally mapping the asthma journey—from diagnosis to ... Triggers can be identified using digital technology to track asthma deterioration, such as symptoms or lung function, and environmental factors.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11405314/

Asthma management in the digital age - PMC Digital tools for monitoring treatment focus on tracking medication use, inhalation technique, and physiological markers such as peak-flow rate ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6917046/

Mobile Health and Inhaler-Based Monitoring Devices for ... Mobile health and web applications (apps), wearables, and other personal monitoring devices have tremendous potential to improve the management of asthma.

7. nature.com nature.com/articles/s41597-023-02241-9

Home monitoring with connected mobile devices for ... Passive monitoring with mobile-health devices, especially when combined with machine-learning, provides an avenue to reduce management burden.