Asma Guardian App for Childhood Asthma

Overseen By Christian Vallejo, MS

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Texas at Austin

Must be taking: Long-term controllers

Disqualifiers: Chronic lung, Cardiovascular, others

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

Compensation: Varies

Number of Visits: 6

Duration: 6 months

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of Asma Guardian, an app designed to help Hispanic/Latinx children manage asthma. The study will determine if using the app improves asthma care compared to usual treatment methods. It seeks children aged 5-12 who frequently experience asthma symptoms and have recently required steroid treatment for an asthma attack. Participants should have access to a smartphone or computer and internet. The trial aims to make asthma care more culturally responsive and effective for these children. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance asthma management for Hispanic/Latinx children.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications. It seems likely that children can continue their current asthma treatments while participating.

What prior data suggests that the Asma Guardian app is safe for children with asthma?

Research shows that the Asma Guardian app offers a new way to help manage asthma in Hispanic/Latinx children. Although specific safety data for the app is not available, the study is in the "Not Applicable" phase. This phase typically indicates low-risk, non-drug methods, and no major safety concerns have been reported so far.

As a tool for managing asthma rather than a medication, the app is likely very safe. It is designed to help control asthma symptoms, potentially leading to fewer asthma attacks and better health for children. While direct safety data for the app is lacking, it does not involve new medications, which usually means fewer risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Asma Guardian app because it offers a new way to manage childhood asthma by using digital technology. Unlike traditional treatments like inhalers and medications, the app provides real-time monitoring and personalized feedback to help children and their caregivers manage symptoms more effectively. Its interactive platform could empower users to better understand their condition and make informed decisions, potentially leading to improved asthma control and quality of life.

What evidence suggests that the Asma Guardian app is effective for childhood asthma?

Research shows that educating caregivers can greatly improve asthma control in children. Studies have found that when caregivers attend at least three education sessions, they learn more about managing asthma effectively, often leading to better asthma outcomes for their children. In this trial, participants in one arm will access the Asma Guardian app, which enhances this educational approach by offering content specifically designed for Hispanic and Latinx families. By increasing caregiver knowledge, the app aims to help manage and control asthma in school-age children. ^{1 6 7 8 9}

Who Is on the Research Team?

Elizabeth Matsui, MD

Principal Investigator

University of Texas at Austin

Are You a Good Fit for This Trial?

This trial is for Hispanic/Latinx parents with a child aged 5-12 who has asthma, uses long-term control medication, or meets criteria for persistent disease. The child must have had nocturnal symptoms and an exacerbation in the past year. Families need tech access for the app-based study but can't join if involved in another asthma study.

Inclusion Criteria

Provision of signed and dated informed consent forms

I am a parent with a child aged 5-12.

My child has persistent asthma, is Hispanic, and we have the tech for a study. We're not in another asthma study.

Exclusion Criteria

Unwilling to provide consent for research activities

I am able to understand and give consent for my treatment.

My child was intubated due to asthma.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive immediate access to the Asma Guardian app for asthma management, education, and environmental intervention for 6 months

6 months

Regular virtual interactions with a community health worker

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of asthma symptoms and app engagement

6 months

6 month follow-up visit

Delayed Access

Participants initially without access receive 1 month of access to the Asma Guardian app after the 6-month study visit

1 month

What Are the Treatments Tested in This Trial?

Interventions

• Asma Guardian

Trial Overview The Asthma Guardian trial tests a culturally tailored app designed to help manage childhood asthma against usual care. Participants are randomly assigned to either get immediate access to the Asma Guardian app or receive delayed access after the study period.

How Is the Trial Designed?

Group I: No Access to Asma Guardian website/app for 6 months Experimental Treatment 1 Intervention

Note: Participants who are randomized to no access will not receive access during the 6 months of the study; however they will receive 1 month of access after their 6 month study visit but any information gained during this time will not be part of analysis.

Group II: Access to Asma Guardian website/app Active Control 1 Intervention

Participants who are randomized to the Asma Guardian website at their baseline visit will have access to the website for 6 months starting at baseline. Access will be turned off at 6 months.

Who Is Running the Clinical Trial?

University of Texas at Austin

Lead Sponsor

Trials

387

Recruited

86,100+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

Published Research Related to This Trial

A systematic review identified 24 asthma management apps suitable for children, with only 4 available in German compared to 20 in English, highlighting a significant gap in German language resources.

English language asthma apps outperformed German apps in key areas such as improving self-management, being child-friendly, and offering a fun learning experience, indicating a need for better development of German language options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effective German and English Language mHealth Apps for Self-management of Bronchial Asthma in Children and Adolescents: Comparison Study. Franzmair, J., Diesner-Treiber, SC., Voitl, JJM., et al.[2021]

The CHANGE Asthma app, designed for children aged 4-11 with poorly controlled asthma, showed significant improvement in asthma control scores for users, indicating its potential effectiveness as an educational tool.

While the app improved individual scores, the overall change in asthma control did not significantly differ from the control group, suggesting that while beneficial, further research is needed to fully establish its efficacy compared to traditional methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dose Matters: A Smartphone Application to Improve Asthma Control Among Patients at an Urban Pediatric Primary Care Clinic. Real, FJ., Beck, AF., DeBlasio, D., et al.[2020]

The electronic-AsthmaTracker (e-AT) significantly improved asthma control and quality of life for children with asthma, as evidenced by reduced missed school days and increased parental satisfaction over a year-long study involving 327 participants.

Participants using e-AT experienced a 32% reduction in emergency department and hospital admissions and a 26% decrease in oral corticosteroid use compared to pre-intervention rates, and they had significantly better outcomes than matched controls.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ambulatory Management of Childhood Asthma Using a Novel Self-management Application. Nkoy, FL., Fassl, BA., Wilkins, VL., et al.[2019]

The Internet-based interactive asthma program, Blue Angel for Asthma Kids, significantly improved asthma management in 164 children over a 12-week trial, leading to reduced nighttime and daytime symptoms, as well as better peak expiratory flow (PEF) measurements.

Participants using the Blue Angel program showed increased adherence to asthma management, improved self-management knowledge, and a better quality of life compared to those receiving traditional care, indicating its effectiveness as a modern tool for asthma care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An internet-based interactive telemonitoring system for improving childhood asthma outcomes in Taiwan. Jan, RL., Wang, JY., Huang, MC., et al.[2007]

A prototype mHealth app designed for children with asthma and their caregivers was positively received, highlighting features like fun learning through manga, effective child-caregiver interaction, and an easy-to-read design.

The app was found to enhance asthma knowledge and self-management, with desired features including monitoring and notification functions, indicating its potential to support ongoing asthma management for children aged 2 to 12.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beneficial Features of a mHealth Asthma App for Children and Caregivers: Qualitative Study. Iio, M., Miyaji, Y., Yamamoto-Hanada, K., et al.[2021]

The Kiss myAsthma smartphone app was well-received by young users aged 15-24, with high satisfaction scores indicating its usability and effectiveness in helping them feel more confident in managing their asthma.

After six weeks of using the app, participants experienced a clinically significant improvement in their asthma quality of life, suggesting that the app can effectively support self-management and health behavior changes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A consumer designed smartphone app for young people with asthma: pilot of engagement and acceptability. Davis, SR., Peters, D., Calvo, RA., et al.[2021]

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 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 six-month asthma self-management program involving one-on-one education by nurse champions significantly improved asthma outcomes in 201 high-risk patients, including better quality of life and increased asthma knowledge.

The program led to notable decreases in missed work or school days, urgent care visits, and hospital admissions, while also increasing preventive care visits by over 40%, highlighting its effectiveness in managing asthma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The effectiveness of one-on-one nurse education on the outcomes of high-risk adult and pediatric patients with asthma. Forshee, JD., Whalen, EB., Hackel, R., et al.[2019]

In a 1-year study involving 310 parents of children with chronic diseases, the incidence of medication errors (MEs) was found to be 0.46 errors per child, with the highest risk observed in children under 1 year old (1.69 errors per child).

Children discharged from the cardiology unit had a significantly higher risk of medication errors (IRR of 3.66), highlighting the need for targeted monitoring and support for this vulnerable group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Cell-Phone Medication Error eHealth App for Managing Safety in Chronically Ill Young Patients at Home: A Prospective Study. Tiozzo, E., Rosati, P., Brancaccio, M., et al.[2023]

A new asthma app designed specifically for young people with asthma was developed using a participatory design approach, involving 20 young patients who contributed to its initial design and provided feedback on usability.

The app received high satisfaction ratings from young co-designers, with a median usability score of 5.3 out of 6, indicating it is both clinically sound and user-friendly, paving the way for further testing on its engagement and effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"Kiss myAsthma": Using a participatory design approach to develop a self-management app with young people with asthma. Davis, SR., Peters, D., Calvo, RA., et al.[2019]

The feasibility study of a mobile health app designed for children aged 0-12 years with asthma showed generally good acceptance, with 60% of caregivers and 63% of children reporting positive evaluations of the app's features after 6 months.

The most utilized feature was the 'record' function, but challenges in app usage were identified, indicating the need for ongoing improvements to enhance user experience and maintain engagement over time.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and Feasibility of a Mobile Asthma App for Children and Their Caregivers: Mixed Methods Study. Iio, M., Sato, M., Narita, M., et al.[2022]

Citations

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A Culturally Tailored Scalable Asthma Intervention for ... The Investigators will examine Asthma Guardian's effects on clinical outcomes as well as process/fidelity outcomes, including uptake and ...

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Effectiveness of pediatric asthma education program in the ... We included 262 patients with a median age of 4.5 years. Asthma education (AE) was taught to 226 (86 %) children, 36 with minimal education (ME) ...

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Family Chaos and Asthma Control | Pediatrics Family chaos emerged as a robust predictor and pathway linking parent depression and child asthma outcomes among urban minority youth.

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Efficacy and safety of budesonide/formoterol pMDI vs ... Budesonide/formoterol pMDI 160/9 μg showed statistically significant and clinically meaningful lung function improvements vs budesonide pMDI 160 μg.