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Feasibility of a Smartphone Application for Asthma Self-management

StatusUnknown
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated October 2, 2024 (before its estimated June 30, 2025 completion). Its status may not reflect the trial's current state.

Record History

  1. Changed Registry marked status Unknown (sponsor has not verified the record since Sep 2024); last known: Recruiting
  2. Primary completion date: May 2024 to Jun 30, 2025
    • Study completion date: May 2024 to Jul 31, 2025
    • Start date: Jun 20, 2023 to Jun 26, 2023
    v6
  3. Re-verified, no change to tracked fieldsv5
  4. Trial status: Not Yet Recruiting to Recruiting
    • Start date changed from estimate of Jun 19, 2023 to Jun 20, 2023
    • Site details revised
    v4
  5. Start date: Jul 2023 to Jun 19, 2023v3
  6. Enrollment target: 20 to 50
    • Primary and study completion dates: Apr 2023 to May 2024
    • Start date: Oct 2022 to Jul 2023
    v2
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05572177
Lead Sponsor University of South Florida
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Conditions
(from sponsor)		 Asthma Chronic
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov