Feasibility of a Smartphone Application for Asthma Self-management

Asthma Chronic Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05572177
• Other study ID #: STUDY000956
• Secondary ID: R34HL145442
• Status: Recruiting
• Phase: N/A
• Start date: June 20, 2023
• Est. completion date: May 2024

Study information

• Verified date: December 2023
• Source: University of South Florida
• Contact: Dipti Karnani
• Phone: 813-974-5193
• Email: diptik[@]usf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: May 2024
• Est. primary completion date: May 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Asthma
• Asthma Chronic

Intervention

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.

Locations

Country	Name	City	State
United States	University of South Florida	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
University of South Florida	National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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.	Baseline and 6 month end-point