RECRUITING

Feasibility of a Smartphone Application for Asthma Self-management

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-06-26
Study Completion:2025-07-31
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05572177

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:12 Years to 17 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD
Inclusion CriteriaExclusion Criteria
  1. * At least 12 and less than 18 years at enrollment
  2. * Established mild, moderate, or severe persistent asthma with a diagnosis verified by clinic physicians
  3. * Speak English
  4. * Not planning on moving out of the Tampa Bay area during the trial period
  5. * Must have a suitable iPhone or Android device available to use with the app
  1. * Having mental or other development disorder that may make self-management of a chronic condition difficult
  2. * 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
  3. * Having participated in the app development phase of the funded project

Contacts and Locations

Study Contact

Dipti Karnani
CONTACT
813-974-5193
diptik@usf.edu
Nataliya Kuzmin
CONTACT
813-974-9157
Nataliyak@usf.edu

Principal Investigator

Amy Alman, PhD
PRINCIPAL_INVESTIGATOR
University of South Florida
Marisa Couluris, DO
PRINCIPAL_INVESTIGATOR
University of South Florida
Paul Rosen, PhD
PRINCIPAL_INVESTIGATOR
University of Utah

Study Locations (Sites)

University of South Florida
Tampa, Florida, 33612
United States

Collaborators and Investigators

Sponsor: University of South Florida

  • Amy Alman, PhD, PRINCIPAL_INVESTIGATOR, University of South Florida
  • Marisa Couluris, DO, PRINCIPAL_INVESTIGATOR, University of South Florida
  • Paul Rosen, PhD, PRINCIPAL_INVESTIGATOR, University of Utah

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-06-26
Study Completion Date2025-07-31

Study Record Updates

Study Start Date2023-06-26
Study Completion Date2025-07-31

Terms related to this study

Additional Relevant MeSH Terms

  • Asthma Chronic