NCT05572177 · University of South Florida
Feasibility of a Smartphone Application for Asthma Self-management
What this study is about
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 randomly assigned controlled trial (RCT). The app is specifically designed to appeal to adolescents.
View original scientific 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.
Interventions
DEVICE
Asthma SMART
The 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.
Primary outcome measures
Recruitment rate (number recruited per month)
Time frame: 6 months
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.
Retention rate (proportion that complete the 6-month trial)
Time frame: 6 months
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.
Technical feasibility (percentage of screened population)
Time frame: 6 months
The percentage of the screened population that has a suitable smartphone and data plan or wi-fi access in order to use the app.
Mean overall usability score obtained from the Health-ITUES
Time frame: Assessed at the end of the 6 month trial
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.
Average app usage per day
Time frame: 6 months
Sustainability of app usage will be defined as the number of days each participant interacted with the app at least once divided by the total number of days in the trial. Interaction is defined as performing any activity in the app.
Adherence to app reminders (proportion of app reminders)
Time frame: 6 months
Adherence to the app will be determined by examining the frequency of responses to app reminders. Adherence will be calculated as the number of activities completed in response to an app reminder divided by the total number of reminders received.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Tampa, Florida
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 2, 2024 · Source of record for eligibility and locations