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

Trial Summary

What is the purpose of this trial?

A randomized controlled trial with parent-child pairs of children with persistent or uncontrolled asthma. An intervention group (n=40 parent-child pairs) will receive the mobile health (mHealth) app and digital sensors with enhanced support from a population health manager role, hereinafter referred to as an asthma coordinator, to provide remote patient monitoring (RPM). A comparison group (n=40 parent-child pairs) will receive the mHealth app and sensors without RPM support to silently collect inhaler use information without mHealth app features. The focus of this project is to evaluate the feasibility and acceptability of delivering a digital intervention for pediatric asthma with RPM in the outpatient setting.

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 data supports the effectiveness of the treatment Technology-Enhanced Asthma Care for childhood asthma?

Research shows that digital technologies, like mobile apps and video therapy, can help children with asthma use their inhalers correctly and stick to their treatment plans, which may reduce hospital visits and improve health outcomes. ^{1 2 3 4 5}

Is the digital intervention for childhood asthma safe for humans?

The research on digital technologies for asthma care, including video therapy and mobile apps, generally focuses on improving treatment adherence and monitoring, with no specific safety concerns reported in the studies. ^{1 3 6 7 8}

How is the Technology-Enhanced Asthma Care treatment different from other asthma treatments?

Technology-Enhanced Asthma Care is unique because it uses digital tools like mobile apps, electronic monitoring devices, and interactive websites to help children manage their asthma. These tools can track symptoms, remind patients to take their medication, and provide education, which can improve adherence and asthma control compared to traditional treatments. ^{2 3 9 10 11}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

References

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

Feasibility of video observed therapy to support controller inhaler use among children in West Baltimore. [2022]

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

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

3. Canada 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. [2021]

4. England pubmed.ncbi.nlm.nih.gov

Interactive digital interventions to promote self-management in adults with asthma: systematic review and meta-analysis. [2022]

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

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

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

Evaluating the ASTHMAXcel Mobile Application Regarding Asthma Knowledge and Clinical Outcomes. [2021]

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

Effectiveness of a Maintenance and Reliever Digihaler System in Asthma: 24-week Randomized Study (CONNECT2). [2023]

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

Electronic adherence monitoring device performance and patient acceptability: a randomized control trial. [2018]

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

Digital Health Technology in Asthma: A Comprehensive Scoping Review. [2021]

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

Use of personal digital assistants by adolescents with severe asthma: can they enhance patient outcomes? [2019]

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

Digital health interventions in children with asthma. [2022]