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Asthma Management App for Asthma (PEAKmAAP Trial)

Little Rock, AR

N/A

Waitlist Available

Led By Tamara T. Perry, MD

Research Sponsored by Arkansas Children's Hospital Research Institute

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age ≥12 and <21 years

Persistent asthma according to national guidelines criteria

Must not have

Significant co-morbid conditions, such as moderate to severe developmental delay that could interfere with the adolescent's ability to self-monitor asthma

Significant underlying respiratory disease other than asthma, such as cystic fibrosis

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 12 months

Awards & highlights

No Placebo-Only Group

Summary

This trial will test how well an app helps manage asthma for 372 adolescents and young adults.

Who is the study for?

This trial is for adolescents and young adults aged 12 to under 21 with persistent asthma, as defined by national guidelines. They must have an ACT score of 19 or less, been prescribed asthma controller medication in the last six months, and have access to a smartphone and internet. It's not for those with other significant respiratory diseases besides asthma, severe co-morbid conditions that could affect self-monitoring, participants in recent clinical trials on asthma, or current smokers.

What is being tested?

The study tests a mobile app designed to help manage asthma more effectively among high-risk patients. The app is based on the traditional written asthma action plan but optimized for smartphones. Participants will be divided into groups: one using the standard care NutriMap app and others using different versions of the PEAKmAAP app.

What are the potential side effects?

Since this trial involves using an m-health intervention rather than medication, there are no direct physical side effects like you'd expect from drugs. However, users might experience stress or frustration if they encounter technical issues with the app.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 12 and 20 years old.

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I have been diagnosed with long-term asthma.

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I have been on asthma control medication in the last 6 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have a health condition that could make it hard for me to manage my asthma on my own.

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I have a serious lung condition other than asthma.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 12 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~12 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 12 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Asthma Control Test (ACT) Score

Secondary study objectives

Asthma Control Classification

Change in Asthma Control Test (ACT) Score to Access

Composite Asthma Severity Index (CASI) score

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: PEAKmAAP-Data Sharing (DS)Experimental Treatment1 Intervention

PEAKmAAP with Data Sharing (PEAKmAAP-DS) group will be asked to enter asthma symptoms or peak flow every day. The PEAKmAAP guides participants when to take asthma medicines and sends reminders to take their medicines every day. PEAKmAAP also provides reminders when to get asthma medicines refilled. Asthma education messages and video links are also pushed via notification. The primary care provided (PCP) will receive monthly reports to help them know how the participant's asthma symptoms are over time.

Group II: PEAKmAAPExperimental Treatment1 Intervention

The Pulmonary Education and Asthma Knowledge mobile asthma action plan (PEAKmAAP) group will use a mobile "app" that will help manage asthma. Participants will be asked to enter asthma symptoms or peak flow every day. The PEAKmAAP guides participants when to take asthma medicines and sends reminders to take their medicines every day. mAAP also provides reminders when to get asthma medicines refilled. Asthma education messages and video links are also pushed via notification.

Group III: Nutrition Map (NutriMap) Usual CareExperimental Treatment1 Intervention

Participants in this arm will use a smartphone application that sends daily non-asthma-related reminder for attention control. Participants will be asked to log their daily fruits and vegetables eaten. Participants will answer survey questions about their asthma and symptoms management.

0 / 5Eligibility criteria met