SMART@Home Digital Platform for Asthma Management

Overseen By Kevin Hommel, PhD

Age: < 18

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

Trial Summary

What is the purpose of this trial?

The proposed research addresses the limitations or lack of a digital platform to provide remote care of medically complex patients. Previous attempts have had poor clinical validity and suffered lack of patient engagement. The study team will deconstruct the previously implemented SMART platforms to create a roadmap, platform, and template to guide clinicians to create new tools. Results from Phase 1 of this project highlighted the need for connectivity between the SMART@Home app and Bluetooth-enable devices to provide objective disease activity data as well as integration with Epic electronic health record so that providers can use the data to inform treatment planning and decision making. A subsequent pilot user validation trial is also needed to confirm development goals were met. Conducting a pilot user validation trial of the SMART@Home asthma tracker, spirometer, and action plan is the purpose of the next phases of this study. A beta test the SMART@Home Asthma Tracker and asthma action plan algorithm will take place with approximately 8 participants. Beta testing will have participants record simulated increases in symptoms to ensure appropriate levels of care is communicated via the app. Then, a group of 40 adolescent (ages 12-17) patients with asthma for a 6-month pilot Randomized Control Trial (RCT). Participants will be randomized into either the IMAAP SMART@Home (n=20) or control (n=20) groups following the completion of baseline measures to test the interactive asthma action plan functionality and impact.

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 data supports the effectiveness of the SMART@Home treatment for asthma management?

Research shows that mobile health apps paired with inhaler sensors can help people manage their asthma better. Additionally, using mobile phones for asthma monitoring has been found to improve asthma control compared to traditional methods. ^{1 2 3 4 5}

Is the SMART@Home Digital Platform for Asthma Management safe for humans?

The safety of asthma treatments has been studied, with some patients reporting tiredness and palpitations as common side effects. However, improving asthma control and patient education may help reduce these adverse effects. ^{6 7 8 9 10}

How is the SMART@Home Digital Platform for Asthma Management different from other asthma treatments?

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. Unlike traditional treatments that focus on medication, this platform empowers patients with real-time data and self-assessment tools to improve asthma control. ^{3 4 11 12 13}

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

Eligibility Criteria

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

I am between 11 and 17 years old.

English fluency for patient and caregiver

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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]

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]

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]

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]

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]

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 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 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]

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 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]

References

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

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

2. United States 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. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

A Wearable IoT Aldehyde Sensor for Pediatric Asthma Research and Management. [2020]

4. 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]

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

Clinical and cost effectiveness of mobile phone supported self monitoring of asthma: multicentre randomised controlled trial. [2023]

6. New Zealand pubmed.ncbi.nlm.nih.gov

Exploratory Study of Signals for Asthma Drugs in Children, Using the EudraVigilance Database of Spontaneous Reports. [2021]

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

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

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

Patient-reported adverse events under asthma therapy: a community pharmacy-based survey. [2015]

9. Switzerland pubmed.ncbi.nlm.nih.gov

Adverse Drug Events Related to Common Asthma Medications in US Hospitalized Children, 2000-2016. [2022]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Post-market surveillance of consumer products: Framework for adverse event management. [2022]

11. Ireland pubmed.ncbi.nlm.nih.gov

Development of online diary and self-management system on e-Healthcare for asthmatic children in Taiwan. [2014]

12. Netherlands pubmed.ncbi.nlm.nih.gov

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

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

Biomedical REAl-Time Health Evaluation (BREATHE): toward an mHealth informatics platform. [2022]