Implementing a Guidelines-Based M-Health Intervention for High Risk Asthma Patients (PEAKmAAP)

Arkansas Children's Hospital Research Institute

Status: Active, not recruiting

Conditions: Pediatric Asthma

Treatments: Behavioral: PEAKmAAP; Behavioral: PEAKmAAP-DS; Behavioral: NutriMap Usual Care

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03842033

206110

1R01NR015988-01A1 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The goal of this research study is to test how good an app is in making asthma easier to manage for 372 adolescents/young adults. The app is a mobile version of the asthma action plan.

Full description

The proposed project aligns with our prior work targeting high-risk pediatric asthma populations in non-inner city environments by targeting adolescents at risk for future exacerbations from the Patient-Centered Medical Home (PCMH) at Arkansas Children's Hospital (ACH).

We propose to conduct a 3-arm randomized, controlled trial with 372 adolescents with uncontrolled asthma to test the effectiveness of mAAP. mAAP provides real-time, personalized feedback, asthma education, and data logging/tracking capabilities.

Enrollment: 370 patients

Sex: All

Ages: 12 to 20 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Age ≥12 and <21 years
• Persistent asthma according to national guidelines criteria
• Asthma Control Test (ACT) score ≤19
• Prescribed a preventive (controller) asthma medication in the past 6 months
• Access to a smartphone compatible with the PEAKmAAP and NutriMap
• Access to the internet
• Able to read and speak English

Exclusion criteria

• Significant underlying respiratory disease other than asthma, such as cystic fibrosis
• Significant co-morbid conditions, such as moderate to severe developmental delay that could interfere with the adolescent's ability to self-monitor asthma
• Current smoker
• Participation in the investigator's or other asthma clinical trials in the previous 6 months

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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370 participants in 3 patient groups

PEAKmAAP

Other group

Description:

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.

Treatment:

Behavioral: PEAKmAAP

PEAKmAAP-Data Sharing (DS)

Other group

Description:

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.

Treatment:

Behavioral: PEAKmAAP-DS

Nutrition Map (NutriMap) Usual Care

Other group

Description:

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.

Treatment:

Behavioral: NutriMap Usual Care