Mobile Health Tool for Asthma

(AIM2ACT Trial)

Recruiting at 1 trial location

Overseen By Mona Sayedul Huq, PhD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: University of Florida

Must be taking: Inhaled corticosteroids

Disqualifiers: Current asthma intervention, Unable to complete procedures

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

Compensation: Varies

Number of Visits: 6

Duration: 3 months

320 Participants Needed

Trial Summary

What is the purpose of this trial?

The aim is to test the efficacy of AIM2ACT and long-term maintenance of treatment effects in a fully-powered randomized controlled trial with 160 early adolescents with poorly controlled persistent asthma, ages 12-15 years, and a caregiver

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop your current medications. However, since it mentions that participants must have an active inhaled corticosteroid prescription, it seems likely that you can continue your current asthma medications.

What data supports the effectiveness of the treatment AIM2ACT, mHealth Attention Control Condition for asthma?

Research shows that mobile health tools, like apps paired with inhaler sensors, can improve asthma management by providing real-time data and enhancing medication adherence. These tools have been found to improve asthma knowledge and control, suggesting that AIM2ACT could be effective in helping patients manage their asthma better. ^{1 2 3 4 5}

What safety data exists for the Mobile Health Tool for Asthma?

There is no specific safety data available for the Mobile Health Tool for Asthma, AIM2ACT, or mHealth Attention Control Condition in the provided research articles. ^{6 7 8 9 10}

How is the AIM2ACT treatment for asthma unique compared to other treatments?

AIM2ACT is unique because it uses a mobile health tool to integrate data from sensors and apps to monitor asthma symptoms and triggers in real-time, helping patients manage their condition more effectively by predicting symptom changes and avoiding triggers. ^{2 3 11 12 13}

Research Team

Sreekala Prabhakaran, M.D.

Principal Investigator

University of Florida

Eligibility Criteria

This trial is for early adolescents aged 12-15 with poorly controlled asthma and their caregivers (18-70 years old). Participants must speak English, live with the caregiver, and have experienced recent frequent asthma symptoms or have a history of severe asthma events. Adolescents should be on inhaled corticosteroids and diagnosed with asthma.

Inclusion Criteria

I have been using an inhaled corticosteroid for at least 4 weeks.

My caregiver is between 18 and 70 years old.

I have had frequent asthma symptoms or needed emergency care for asthma recently.

Exclusion Criteria

Your family is currently getting extra help for managing asthma.

I cannot do the study tasks by myself.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the AIM2ACT mHealth intervention or mHealth attention control condition

3 months

Regular virtual check-ins

Follow-up

Participants are monitored for safety and effectiveness after treatment

9 months

Assessments at 6 months and 12 months

Treatment Details

Interventions

• AIM2ACT
• mHealth Attention Control Condition

Trial Overview The AIM2ACT study tests a mobile health tool designed to help young teens manage their asthma against an attention control condition. It's a randomized controlled trial involving 160 pairs of adolescents and caregivers to see if the tool can improve long-term asthma control.

Participant Groups

Group I: AIM2ACT Experimental Treatment 1 Intervention

AIM2ACT is the experimental arm for the trial. AIM2ACT is a dyadic mHealth intervention designed to sustain caregiver involvement and monitoring as well as guide dyads through collaborative asthma management.

Group II: mHealth Attention Control Condition Active Control 1 Intervention

The mHealth attention control condition is the active comparator arm in the trial that accounts for staff attention and novelty of technology based asthma management intervention.

Who Is Running the Clinical Trial?

University of Florida

Lead Sponsor

Trials

1,428

Recruited

987,000+

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator

Trials

3,987

Recruited

47,860,000+

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 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]

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]

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]

The number of asthma management apps more than doubled from 93 in 2011 to 191 in 2013, but many of these newer apps still lack comprehensive and evidence-based information, with only 13% providing supported self-care procedures.

Despite an increase in apps targeting specific skills like acute asthma management and inhaler technique, the overall quality remains low, with only 17% and 25% of these apps adhering to clinical guidelines and proper inhaler instructions, respectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The evolution of mobile apps for asthma: an updated systematic assessment of content and tools. Huckvale, K., Morrison, C., Ouyang, J., et al.[2022]

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

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

3. England pubmed.ncbi.nlm.nih.gov

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

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

Technology Interventions for Nonadherence: New Approaches to an Old Problem. [2019]

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

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

6. England pubmed.ncbi.nlm.nih.gov

The evolution of mobile apps for asthma: an updated systematic assessment of content and tools. [2022]

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

The Danish severe asthma register: an electronic platform for severe asthma management and research. [2023]

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

Real-life studies and registries of severe asthma: The advent of digital technology. [2023]

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

The safety of asthma medications during pregnancy and lactation: Clinical management and research priorities. [2022]

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

Internet-Based Monitoring in the Severe Asthma Research Program Identifies a Subgroup of Patients With Labile Asthma Control. [2020]

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

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

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

Mobile Health and Inhaler-Based Monitoring Devices for Asthma Management. [2020]

13. England pubmed.ncbi.nlm.nih.gov

Development and validation of an electronic daily control score for asthma (e-DASTHMA): a real-world direct patient data study. [2023]