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| ID | Type | Description | Link |
|---|---|---|---|
| R34HL145442 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Heart, Lung, and Blood Institute (NHLBI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Asthma SMART | Experimental | 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. |
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| Standard of care | No Intervention | Subjects randomized to the standard-of-care arm will continue to receive regular care for their condition. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Asthma SMART | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Dipti Karnani | Contact | 813-974-5193 | diptik@usf.edu | |
| Nataliya Kuzmin | Contact | 813-974-9157 | Nataliyak@usf.edu |
| Name | Affiliation | Role |
|---|---|---|
| Amy Alman, PhD | University of South Florida | Principal Investigator |
| Marisa Couluris, DO | University of South Florida | Principal Investigator |
| Paul Rosen, PhD |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of South Florida | Recruiting | Tampa | Florida | 33612 | United States |
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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 |
| University of Utah |
| Principal Investigator |