AIM2ACT: A Mobile Health Tool to Help Adolescents Self-Manage Asthma

University of Florida

Status: Active, not recruiting

Conditions: Asthma

Treatments: Behavioral: mHealth Attention Control Condition; Behavioral: AIM2ACT

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04448002

R01HL153119 (U.S. NIH Grant/Contract)

IRB202000748

Details and patient eligibility

About

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

Enrollment: 320 estimated patients

Sex: All

Ages: 12 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria are:

1. Adolescent is 12-15 years old

2. Caregiver is between 18-70 years-old

3. Adolescent lives in the residence of caregiver

4. Adolescent and caregiver can speak and read English

5. (a) Adolescent has been diagnosed as having asthma, OR (b) Doctor has stated the adolescent has asthma, OR (c) Adolescent has had breathing problems in the past 12 months

6. Adolescent has had an active inhaled corticosteroid prescription for ≥ 4 weeks

7. (a) During the past 14 days (that is, during the past fourteen 24-hour periods that include daytime and nighttime), the adolescent has experienced one or more of the following: (i) Asthma symptoms such as wheezing, shortness of breath, or tightness in the chest, or cough on more than 4 separate days; (ii) Woken up because of asthma symptoms such as wheezing, shortness of breath, or tightness in the chest, or cough on 1 or more separate nights; (iii) Had to slow down or stop play or usual activities or missed school because of asthma, wheezing, or tightness in the chest, or cough on more than 4 separate days; (iv) Used any asthma rescue medicine (sometimes called a quick relief medicine) on more than 4 separate days

   • OR

     (b) In the past year, adolescent has had one or more of the following: (i) 2 or more exacerbations requiring oral systemic corticosteroids; (ii) 2 or more emergency department visits; (iii) 1 hospitalization; (iv) 2 or more urgent medical care visits due to asthma

   • OR

     (c) Adolescent scores 19 or lower on the Asthma Control Test

Exclusion criteria are -

Families will be excluded if:

1. The family is currently involved in an asthma management intervention above and beyond usual care, OR
2. Adolescent is unable to complete study procedures independently.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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320 participants in 2 patient groups

AIM2ACT

Experimental group

Description:

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.

Treatment:

Behavioral: AIM2ACT

mHealth Attention Control Condition

Active Comparator group

Description:

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.

Treatment:

Behavioral: mHealth Attention Control Condition