Recruiting

Feasibility of a Smartphone Application for Asthma Self-management

ClinicalTrials.gov IDNCT05572177

PhaseNA

Enrollment50

SponsorUniversity of South Florida

Age12 Years

SexALL

I'm interested View official listing

Conditions studied

Asthma Chronic

About this study

The primary goal of this project is to determine the feasibility, acceptability, and adherence of a smartphone application for improving asthma self-management in a pilot randomized controlled trial (RCT). The app is specifically designed to appeal to adolescents. Adolescents with persistent asthma will be randomized to receive: 1) standard-of-care or 2) the self-management app in addition to standard-of-care. Feasibility will be assessed by the ability to recruit and retain subjects, technical barriers to implementation, and the appropriateness of the intervention among adolescents and providers. The acceptability of the intervention will be determined by appraising perceived usefulness, entertainment, and ease of use of the app. Adherence to usage of the app over a 6-month period will be assessed by examining the frequency of app usage and the features that were used, and the extent of data regarding self-management that was entered. A secondary objective is to obtain preliminary estimates of effectiveness of the app on clinical outcomes (ACT score, spirometry, CHSA-C, exacerbations, and medication adherence) relative to standard-of-care. It is hypothesized that the app will result in a high level of adherence and will be a feasible and acceptable intervention to improve self-management among adolescents with persistent asthma.

Interventions

Device: Asthma SMART — The intervention is a smartphone application to improve self-management of asthma designed to appeal to adolescents. The app integrates four components to facilitate asthma self-management: 1) self-monitoring of peak-flow and symptoms; 2) graphical health user interfaces with avatars, infographics, and rewards; 3) interactive educational materials; and 4) patient-provider interactions.

Primary outcomes

Recruitment rate (number recruited per month) (6 months)
Retention rate (proportion that complete the 6-month trial) (6 months)
Technical feasibility (percentage of screened population) (6 months)
Mean overall usability score obtained from the Health-ITUES (Assessed at the end of the 6 month trial)
Average app usage per day (6 months)
Adherence to app reminders (proportion of app reminders) (6 months)

Eligibility information

Inclusion Criteria: * At least 12 and less than 18 years at enrollment * Established mild, moderate, or severe persistent asthma with a diagnosis verified by clinic physicians * Speak English * Not planning on moving out of the Tampa Bay area during the trial period * Must have a suitable iPhone or Android device available to use with the app Exclusion Criteria: * Having mental or other development disorder that may make self-management of a chronic condition difficult * Having other chronic lung disease or one or more of the following disorders including cystic fibrosis, neuromuscular disease, immunodeficiency or autoimmune disorders, blindness or severe vision impairment that may interfere with the ability to use the mobile app * Having participated in the app development phase of the funded project

Study locations

University of South Florida, Tampa, Florida 33612 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.