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Feasibility of a Smartphone Application for Asthma Self-management

Primary Purpose

Asthma Chronic

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Asthma SMART
Sponsored by
University of South Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Asthma Chronic

Eligibility Criteria

12 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of South FloridaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Asthma SMART

Standard of care

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

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.

Full Information

First Posted
July 25, 2022
Last Updated
June 21, 2023
Sponsor
University of South Florida
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)
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1. Study Identification

Unique Protocol Identification Number
NCT05572177
Brief Title
Feasibility of a Smartphone Application for Asthma Self-management
Official Title
Feasibility of mHealth Technology for Improving Self-Management and Adherence Among Asthmatic Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 20, 2023 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
May 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of South Florida
Collaborators
National Heart, Lung, and Blood Institute (NHLBI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma Chronic

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Asthma SMART
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard of care
Arm Type
No Intervention
Arm Description
Subjects randomized to the standard-of-care arm will continue to receive regular care for their condition.
Intervention Type
Device
Intervention Name(s)
Asthma SMART
Intervention Description
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 Measure Information:
Title
Recruitment rate (number recruited per month)
Description
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 months
Title
Retention rate (proportion that complete the 6-month trial)
Description
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 months
Title
Technical feasibility (percentage of screened population)
Description
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 months
Title
Mean overall usability score obtained from the Health-ITUES
Description
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 trial
Title
Average app usage per day
Description
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.
Time Frame
6 months
Title
Adherence to app reminders (proportion of app reminders)
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change in ACT score from baseline to the 6-month end point
Description
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-point

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Research Coordinator
Phone
813-974-2235
Email
jcreed3@usf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Amy Alman, PhD
Organizational Affiliation
University of South Florida
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Marisa Couluris, DO
Organizational Affiliation
University of South Florida
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Paul Rosen, PhD
Organizational Affiliation
University of South Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

Feasibility of a Smartphone Application for Asthma Self-management

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