Mobile Health Tool for Asthma

(AIM2ACT Trial)

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a mobile health tool called AIM2ACT to help manage asthma in early adolescents. The goal is to determine if this tool effectively supports asthma management by involving caregivers and guiding families in handling asthma together. Participants are children aged 12-15 with poorly controlled asthma, meaning they experience frequent symptoms or disruptions in daily life due to asthma. The trial compares AIM2ACT to another mobile health condition, the mHealth Attention Control Condition, to evaluate which works better. Participants must live with a caregiver and have a recent history of asthma issues. As an unphased trial, this study offers participants the chance to contribute to innovative research that could improve asthma management for families.

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 prior data suggests that this mobile health tool is safe for adolescents with asthma?

Research shows no specific safety information is available for AIM2ACT, the mobile health tool tested to help manage asthma in teenagers. The trial's "Not Applicable" phase label indicates that AIM2ACT is not a drug but likely involves behavioral methods or technology, which typically carry different risks than medication trials.

Mobile health tools like AIM2ACT generally aim to improve asthma management and increase caregiver involvement. They are usually considered low-risk compared to medications because they don't involve ingesting substances. The research provided reports no negative effects related to AIM2ACT. Prospective participants should discuss any concerns with study coordinators or their healthcare provider. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about AIM2ACT because it offers a new way to manage asthma by using mobile health technology. Unlike traditional treatments that often focus solely on medication, AIM2ACT is designed to enhance collaboration between caregivers and patients, guiding them through asthma management together. This approach not only involves caregivers more actively but also leverages technology to provide real-time support and monitoring, which is different from the usual reliance on periodic doctor visits and self-reported symptoms. By integrating caregivers into the management process, AIM2ACT aims to improve overall asthma care and outcomes.

What evidence suggests that AIM2ACT is effective for asthma?

Research shows that AIM2ACT, which participants in this trial may receive, can significantly help teens manage their asthma. Teens who used AIM2ACT demonstrated improved asthma control compared to those who did not. These improvements were evident and made a real difference in managing asthma. AIM2ACT involves caregivers and supports teens in managing their condition. This mobile health tool has shown promise in improving life for teens with poorly controlled asthma. ^{1 4 6 7 8}

Who Is on the Research Team?

Sreekala Prabhakaran, M.D.

Principal Investigator

University of Florida

Are You a Good Fit for This Trial?

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.

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

I have asthma or have had breathing issues in the last year.

Exclusion Criteria

Your family is currently getting extra help for managing asthma.

I cannot do the study tasks by myself.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10071332/

AIM2ACT: Randomized controlled trial protocol for a mobile ... ... AIM2ACT is efficacious and the extent to which it leads to sustained improvements in asthma control and other outcomes. AIM2ACT is the first mHealth ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5742020/

Applying Interactive Mobile health to Asthma Care in Teens ... A pilot randomized controlled trial of AIM2ACT will be conducted with 50 early adolescents with poorly controlled asthma and a caregiver.

3. jahonline.org jahonline.org/article/S1054-139X(21)00293-7/fulltext

Using Mobile Health to Improve Asthma Self-Management ... AIM2ACT is a dyadic mobile health intervention designed to increase helpful caregiver support as early adolescents engage in asthma self-management behaviors.

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1054139X21002937

Using Mobile Health to Improve Asthma Self-Management ... Participants randomized to AIM2ACT had significant improvements in asthma control scores (p = .04) compared to control that surpassed the minimally clinically ...

5. researchgate.net researchgate.net/publication/365378795_AIM2ACT_Randomized_controlled_trial_protocol_for_a_mobile_health_intervention_for_early_adolescents_with_asthma

Randomized controlled trial protocol for a mobile health ... Efficacy outcomes, including family asthma management, lung function, adolescent asthma control, asthma-related quality of life, and self ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT02302040

Applying Interactive Mobile Health to Asthma Care in ... The aims of this application are to develop and test AIM2ACT, a mobile health (mHealth) tool, delivered via smartphones, that fosters helpful caregiver ...

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S155171441730188X

Applying Interactive Mobile health to Asthma Care in Teens ... The AIM2ACT intervention uses a mHealth tool designed to help early adolescents diagnosed with persistent asthma develop and master asthma self-management ...

8. withpower.com withpower.com/trial/mobile-health-tool-for-asthma-0e27f

Mobile Health Tool for Asthma (AIM2ACT Trial) There is no specific safety data available for the Mobile Health Tool for Asthma, AIM2ACT, or mHealth Attention Control Condition in the provided research ...