Digital Intervention for Childhood Asthma

(TEACCCH Trial)

Overseen By Olivia Orr

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago

Must be taking: Inhaled corticosteroids

Disqualifiers: Cystic fibrosis, Cyanotic heart disease, others

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

Compensation: Varies

Number of Visits: 1

Duration: 12 months

80 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore the effectiveness of a digital tool for children with ongoing or hard-to-control asthma. It involves using a mobile app and sensors to track inhaler use, with some families receiving additional support from an asthma coordinator. This approach, known as Technology-Enhanced Asthma Care, seeks to determine if it makes asthma management easier and more effective. Families with children aged 4-17 who frequently experience asthma symptoms or use inhalers often might be suitable candidates. As an unphased trial, this study provides families the opportunity to contribute to innovative asthma care solutions.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it mentions that children must be prescribed certain asthma medications, so it's likely you can continue with those.

What prior data suggests that this digital intervention is safe for children with asthma?

Research has shown that digital tools, like those used in this asthma study, have been developed to help manage asthma in children. These tools often include apps and smart inhalers that track medication use and symptoms. One study found that about 70% of these digital health tools helped children with asthma adhere to their medication regimen.

Other studies suggest that these digital tools can simplify tracking symptoms and medication use for families, thereby improving asthma management. There is no strong evidence of serious side effects from using these apps and devices. They are generally safe because they focus on tracking and monitoring rather than altering medication.

Overall, digital asthma care tools are considered safe and can help improve asthma control. However, they should complement regular medical care, not replace it. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Digital Asthma Intervention because it uses cutting-edge technology to enhance asthma care for children. Unlike traditional treatments that rely solely on medication, this intervention integrates a mobile health app and inhaler sensors to provide real-time data, helping parents and healthcare providers monitor asthma symptoms more effectively. The app allows an asthma coordinator to actively engage with families, ensuring adherence to treatment plans and improving symptom management. This personalized and interactive approach could lead to better asthma control and quality of life for children, making it a promising advancement in asthma care.

What evidence suggests that this digital intervention is effective for childhood asthma?

Research has shown that mobile health (mHealth) technologies can enhance asthma care by simplifying medication adherence and symptom control. In this trial, participants in the Digital Asthma Intervention arm will receive digital tools such as apps and sensors. Studies have demonstrated that these tools can significantly improve asthma management in children. One review found that 70% of studies on digital interventions reported better treatment adherence. Although evidence for improving lung function and quality of life remains limited, technology still offers promising support for asthma management. Overall, digital tools appear to help children adhere to their treatment plans and manage their asthma more effectively. ^{1 2 3 5 6}

Are You a Good Fit for This Trial?

This trial is for parent-child pairs where the child has persistent or uncontrolled asthma. It's important that they have not been part of similar studies before and are comfortable using a mobile health app and digital sensors.

Inclusion Criteria

My asthma is frequent and hard to control.

The child is a patient in Primary Care Uptown, Primary Care Deming, Allergy, or Pulmonary Clinics at LCH.

I work for LCH and can give informed consent.

Exclusion Criteria

Consent is not obtained from the parent/guardian.

The caregiver has a smartphone that is not compatible with the Hailie® app.

The family has active Department of Child and Family Services (DCFS) involvement.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the mHealth app and digital sensors, with or without remote patient monitoring, to manage asthma over a 12-month period

12 months

Baseline, 1, 3, 6, 9, and 12 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Technology-Enhanced Asthma Care

Trial Overview

The study tests a digital asthma care approach. Half the participants will use an mHealth app with remote monitoring by an asthma coordinator, while the other half will use the same technology without active support to track inhaler usage.

How Is the Trial Designed?

Group I: Digital Asthma Intervention Experimental Treatment 1 Intervention

The intervention group will receive digital tools (mHealth app and sensors) and remote patient monitoring (RPM) assisted by an asthma coordinator, that supports an enhanced standard of care for their child's asthma. The mHealth intervention includes inhaler sensors on their rescue (SABA) and ICS inhaler and a mHealth app on the parent's smartphone. The asthma coordinator, as part of the implementation plan, will respond to information from the mHealth app and contact the participants about their adherence and asthma symptom control, following an algorithm aligned with NAEPP guidelines.

Group II: Comparison Active Control 1 Intervention

The comparison group will also receive enhanced standard of asthma care. A research "control" version of the mHealth app will be downloaded to smartphones to allow for data collection from inhaler sensors, but the mHealth app will only silently transmit data to the web portal and not provide any app interaction or feedback to participants.

Who Is Running the Clinical Trial?

Ann & Robert H Lurie Children's Hospital of Chicago

Lead Sponsor

Trials

275

Recruited

5,182,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

Medication adherence in pediatric asthma patients is alarmingly low, with rates estimated to be below 50%, despite healthcare providers' efforts to educate and intervene.

Digital health interventions, such as mobile apps and electronic monitoring devices, show promise in improving adherence and asthma control, but their variable results and implementation challenges limit widespread clinical adoption.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital health interventions in children with asthma. Ferrante, G., Licari, A., Marseglia, GL., 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 systematic review of 5 trials involving 593 participants found that interactive digital interventions for asthma self-management show some promise, with small beneficial effects on asthma control and quality of life, although the overall evidence is weak due to high variability among studies.

No significant harm was identified from these digital interventions, suggesting they are safe for use in adults with asthma, but more large-scale, robust trials are needed to strengthen the evidence base.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Interactive digital interventions to promote self-management in adults with asthma: systematic review and meta-analysis. McLean, G., Murray, E., Band, R., et al.[2022]

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]

Interactive digital interventions that allow two-way communication between patients and healthcare providers significantly improve adherence to asthma treatments and reduce patients' impairment due to asthma, as shown in a review of 121 studies.

Non-individualized digital interventions can help with adherence to inhaled corticosteroids but do not improve overall asthma burden, highlighting the importance of personalization and engagement in digital health solutions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital Health Technology in Asthma: A Comprehensive Scoping Review. Mosnaim, G., Safioti, G., Brown, R., et al.[2021]

In a 60-day pilot study involving 21 children aged 2-18 with sub-optimally controlled asthma, a novel video directly observed therapy (DOT) program showed high acceptability and engagement, with participants submitting a total of 810 videos.

The program significantly improved inhaler technique, with the median inhaler error rate dropping from 73% to 8% within the first two weeks, indicating that the digital intervention effectively supported correct inhaled corticosteroid use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of video observed therapy to support controller inhaler use among children in West Baltimore. McIntire, K., Weis, B., Litwin Ye, L., et al.[2022]

The increasing rates of asthma mortality and disability, particularly among adolescents, highlight the urgent need for improved management strategies.

Handheld wireless devices, like personal digital assistants, can play a crucial role in preventing emergency department visits and enhancing outcomes for patients with severe persistent asthma, with recommendations for nurses to be actively involved in the program's design and evaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of personal digital assistants by adolescents with severe asthma: can they enhance patient outcomes? Chang, BL., Omery, A., Mayo, A.[2019]

Digital technologies have been developed to improve asthma care in children and adolescents, with 70% of studies showing improved treatment adherence, indicating their potential effectiveness in supporting medication compliance.

However, the evidence for these technologies improving asthma control and health outcomes is mixed, highlighting the need for further research to understand their true impact and integration into existing healthcare systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Digital Technologies for Monitoring and Improving Treatment Adherence in Children and Adolescents With Asthma: Scoping Review of Randomized Controlled Trials. Milne-Ives, M., Lam, C., Meinert, E.[2021]

The ASTHMAXcel mobile application significantly improved asthma control and knowledge among adults, as evidenced by increased scores on the Asthma Control Test and Asthma Knowledge Questionnaire over 6 months.

Using ASTHMAXcel led to a notable reduction in asthma-related emergency department visits and hospitalizations, as well as decreased reliance on prednisone, highlighting its potential as an effective tool for outpatient asthma management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the ASTHMAXcel Mobile Application Regarding Asthma Knowledge and Clinical Outcomes. Hsia, BC., Wu, S., Mowrey, WB., et al.[2021]

The Digihaler System (DS) significantly improved asthma control in participants compared to standard-of-care inhalers, with a 35% higher odds of achieving well-controlled asthma after 24 weeks, based on a study of 391 participants aged 13 and older.

Participants using the DS showed good adherence to maintenance treatment and a 38.2% reduction in reliever inhaler use, indicating that the digital health tools effectively supported better asthma management and clinician engagement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a Maintenance and Reliever Digihaler System in Asthma: 24-week Randomized Study (CONNECT2). Mosnaim, GS., Hoyte, FCL., Safioti, G., et al.[2023]

The study involved 1306 quality control tests of an electronic monitoring device for asthma inhalers, showing a high reliability rate of 84% for pre-issue tests and 87% for return tests, although some devices had issues with under-recording.

Children using the device with reminder features reported significantly higher acceptability scores compared to those without reminders, with over 90% finding the device easy to use, indicating strong potential for improving asthma management in this age group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Electronic adherence monitoring device performance and patient acceptability: a randomized control trial. Chan, AHY., Stewart, AW., Harrison, J., et al.[2018]

Citations

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Digital Intervention for Childhood Asthma (TEACCCH Trial)

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