Feasibility of a Smartphone Application for Asthma Self-management
Feasibility of MHealth Technology for Improving Self-Management and Adherence Among Asthmatic Adolescents
2 other identifiers
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 25, 2022
CompletedFirst Posted
Study publicly available on registry
October 7, 2022
CompletedStudy Start
First participant enrolled
June 26, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2025
CompletedOctober 2, 2024
September 1, 2024
2 years
July 25, 2022
September 30, 2024
Conditions
Outcome Measures
Primary Outcomes (6)
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.
6 months
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.
6 months
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.
6 months
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.
Assessed at the end of the 6 month trial
Average app usage per day
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.
6 months
Adherence to app reminders (proportion of app reminders)
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.
6 months
Secondary Outcomes (1)
Change in ACT score from baseline to the 6-month end point
Baseline and 6 month end-point
Study Arms (2)
Asthma SMART
EXPERIMENTALSubjects 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.
Standard of care
NO INTERVENTIONSubjects randomized to the standard-of-care arm will continue to receive regular care for their condition.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of South Florida
Tampa, Florida, 33612, United States
Study Officials
- PRINCIPAL INVESTIGATOR
Amy Alman, PhD
University of South Florida
- PRINCIPAL INVESTIGATOR
Marisa Couluris, DO
University of South Florida
- PRINCIPAL INVESTIGATOR
Paul Rosen, PhD
University of Utah
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DEVICE FEASIBILITY
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 25, 2022
First Posted
October 7, 2022
Study Start
June 26, 2023
Primary Completion
June 30, 2025
Study Completion
July 31, 2025
Last Updated
October 2, 2024
Record last verified: 2024-09