Recruiting

Observational Study

Sponsor:

University of South Florida

Code:

NCT05572177

Conditions

Asthma Chronic

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Not accepted

Interventions

Asthma SMART

Study Details

Brief summary:

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.

Conditions

Asthma Chronic

Study ID

NCT05572177

Start date

Jun 26, 2023

Status verified date

Sep, 2024

Completion date

Jul 31, 2025

Anticipated

Primary completion date

Jun 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12 - 17

Healthy Volunteers: Not accepted

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 Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

experimental: Asthma SMART

Subjects randomized to the intervention arm will be provided with the app to download to their personal iPhone or Android smartphone. Subjects will be asked to use the app every day for 6 months.

no intervention: Standard of care

Subjects randomized to the standard-of-care arm will continue to receive regular care for their condition.

Interventions

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 outcome measure

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

Central Contacts and Locations

Central contacts

Dipti Karnani

813-974-5193diptik@usf.edu

Nataliya Kuzmin

813-974-9157Nataliyak@usf.edu

Locations

University of South Florida

Recruiting

Tampa, Florida, United States, 33612

More Information

Sponsor

University of South Florida

Last update posted

Oct 2, 2024

Last verified

Sep, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of South Florida on 2024-10-02.