Feasibility of a Smartphone Application for Asthma Self-management
ConditionAsthma Chronic
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age12-17
SponsorUniversity of South Florida
About this trial
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
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Asthma SMART
DeviceThe 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.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Asthma SMARTExperimental treatment 1 intervention
Group B: Standard of careNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Recruitment rate (number recruited per month)
The recruitment rate will be defined as the total number of participants recruited divided by the number of months of recruitment to determine the approximate number of participants recruited in a single site per month.
Time frame
6 months2
Retention rate (proportion that complete the 6-month trial)
The retention rate will be calculated as the number of participants that complete the 6 month follow-up exam divided by the total number of participants randomized in the study.
Time frame
6 months3
Technical feasibility (percentage of screened population)
The percentage of the screened population that has a suitable smartphone and data plan or wi-fi access in order to use the app.
Time frame
6 months4
Mean overall usability score obtained from the Health-ITUES
The Health Information Technology Usability Evaluation Scale is a validated survey of usability of mobile health technology consisting of 20 questions each on a 5-point Likert scale with four subscale domains on impact, perceived usefulness, perceived ease of use, and user control. The total score is calculated as the average score across the domains with a value range from 1 to 5. Higher scores represent greater usability.
Time frame
Assessed at the end of the 6 month trialSecondary outcomes
1
Change in ACT score from baseline to the 6-month end point
The ACT test is a validated 5-question survey used to measure asthma control according to NHLBI guidelines. Total scores range from 5 to 25. Change will be calculated as the 6-month ACT score - baseline ACT score.
Time frame
Baseline and 6 month end-pointSponsors and contacts
Click on the lead sponsor to view all of their trials.
University of South Florida
Lead sponsor
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator
Source ClinicalTrials.gov