Clinical trial NCT05572177: Feasibility of a Smartphone Application for Asthma Self-management
Official title: Feasibility of MHealth Technology for Improving Self-Management and Adherence Among Asthmatic Adolescents
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Asthma Chronic
Lead sponsor: University of South Florida
Sponsor class: OTHER
Collaborators: name: National Heart, Lung, and Blood Institute (NHLBI)
First posted: 2022-10-07
Enrollment: 50
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DEVICE_FEASIBILITY

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.


Eligibility criteria: 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

Primary outcomes:
measure: Recruitment rate (number recruited per month)
timeFrame: 6 months
measure: Retention rate (proportion that complete the 6-month trial)
timeFrame: 6 months
measure: Technical feasibility (percentage of screened population)
timeFrame: 6 months
measure: Mean overall usability score obtained from the Health-ITUES
timeFrame: Assessed at the end of the 6 month trial
measure: Average app usage per day
timeFrame: 6 months
measure: Adherence to app reminders (proportion of app reminders)
timeFrame: 6 months
Secondary outcomes:
measure: Change in ACT score from baseline to the 6-month end point
timeFrame: Baseline and 6 month end-point
Other outcomes:
Locations:
city: Tampa
country: United States
facility: University of South Florida
state: Florida
Study officials:
affiliation: University of South Florida
name: Amy Alman, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of South Florida
name: Marisa Couluris, DO
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Utah
name: Paul Rosen, PhD
role: PRINCIPAL_INVESTIGATOR
References: