Feasibility of MHealth Technology for Improving Self-Management and Adherence Among Asthmatic Adolescents

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 17
Healthy Volunteers: f
View:

• 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

Locations
United States
Florida
University of South Florida
RECRUITING
Tampa
Contact Information
Primary
Dipti Karnani
diptik@usf.edu
813-974-5193
Backup
Nataliya Kuzmin
Nataliyak@usf.edu
813-974-9157
Time Frame
Start Date: 2023-06-26
Estimated Completion Date: 2025-07-31
Participants
Target number of participants: 50
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: University of South Florida
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)

This content was sourced from clinicaltrials.gov