AIM2ACT: A Mobile Health Tool to Help Adolescents Self-Manage Asthma
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Florida
- Enrollment
- 320
- Locations
- 2
- Primary Endpoint
- Asthma Control using asthma control questionnaire
Study Overview
Brief Summary
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 12 Years to 70 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Adolescent is 12-15 years old
- •Caregiver is between 18-70 years-old
- •Adolescent lives in the residence of caregiver
- •Adolescent and caregiver can speak and read English
- •(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
- •Adolescent has had an active inhaled corticosteroid prescription for ≥ 4 weeks
- •(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
- •(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
- •(c) Adolescent scores 19 or lower on the Asthma Control Test
Exclusion Criteria
- •Families will be excluded if:
- •The family is currently involved in an asthma management intervention above and beyond usual care, OR
- •Adolescent is unable to complete study procedures independently.
Arms & Interventions
AIM2ACT
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.
Intervention: AIM2ACT (Behavioral)
mHealth Attention Control Condition
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.
Intervention: mHealth Attention Control Condition (Behavioral)
Outcomes
Primary Outcomes
Asthma Control using asthma control questionnaire
Time Frame: Change in baseline, post-intervention,3 months, and 6 months, and 12 month follow-up
Measured via the Asthma Control Test questionnaire which has 5 items that assesses frequency of daytime and nocturnal asthma symptoms, activity limitations, and perceptions of disease control.Adolescents will complete all 5 items independently of caregivers. Scores range from 5 (poor control of asthma) to 25 (complete control of asthma), with higher scores reflecting greater asthma control. An ACT score \>19 indicates well-controlled asthma."
Secondary Outcomes
No secondary outcomes reported