Status:
ACTIVE_NOT_RECRUITING
AIM2ACT: A Mobile Health Tool to Help Adolescents Self-Manage Asthma
Lead Sponsor:
University of Florida
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Asthma
Eligibility:
All Genders
12-70 years
Phase:
NA
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 as...
Eligibility Criteria
Inclusion
- Inclusion criteria are:
- 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
- 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:
- The family is currently involved in an asthma management intervention above and beyond usual care, OR
- Adolescent is unable to complete study procedures independently.
Exclusion
Key Trial Info
Start Date :
April 23 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 31 2026
Estimated Enrollment :
320 Patients enrolled
Trial Details
Trial ID
NCT04448002
Start Date
April 23 2021
End Date
March 31 2026
Last Update
March 13 2025
Active Locations (2)
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1
UF Health Pediatrics
Gainesville, Florida, United States, 32610
2
Nemours Children's Hospital
Jacksonville, Florida, United States, 32207