Feasibility of a Smartphone Application for Asthma Self-management

NCT ID: NCT05572177

Last Updated: 2024-10-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-06-26
• Study Completion Date: 2025-07-31

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.

Conditions

Asthma Chronic

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DEVICE_FEASIBILITY
• Blinding Strategy: NONE

Study Groups

Asthma SMART

Subjects 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.

Group Type: EXPERIMENTAL

Asthma SMART

Intervention Type: DEVICE

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.

Standard of care

Subjects randomized to the standard-of-care arm will continue to receive regular care for their condition.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Heart, Lung, and Blood Institute (NHLBI)

NIH

Sponsor Role: collaborator

University of South Florida

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Amy Alman, PhD

Role: PRINCIPAL_INVESTIGATOR

University of South Florida

Marisa Couluris, DO

Role: PRINCIPAL_INVESTIGATOR

University of South Florida

Paul Rosen, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Utah

Locations

University of South Florida

Tampa, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Dipti Karnani

Role: CONTACT

diptik@usf.edu

813-974-5193

Nataliya Kuzmin

Role: CONTACT

Nataliyak@usf.edu

813-974-9157

Other Identifiers

R34HL145442

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY000956

Identifier Type: -

Identifier Source: org_study_id