Clinical trial NCT04448002: AIM2ACT: A Mobile Health Tool to Help Adolescents Self-Manage Asthma
Official title: AIM2ACT: A Mobile Health Tool to Help Adolescents Self-Manage Asthma
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Asthma
Keywords: Adolescent
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2020-06-25
Enrollment: 320
Sex: ALL
Minimum age (years): 12
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Block randomization will ensure a 1:1 ratio
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Asthma Control using asthma control questionnaire
timeFrame: Change in baseline, post-intervention,3 months, and 6 months, and 12 month follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: UF Health Pediatrics
state: Florida
city: Jacksonville
country: United States
facility: Nemours Children's Hospital
state: Florida
Study officials:
affiliation: University of Florida
name: Sreekala Prabhakaran, M.D.
role: PRINCIPAL_INVESTIGATOR
References: