Feasibility of a Smartphone Application for Asthma Self-management

Официальное название

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

Обзор

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.

Вмешательства

• Устройство 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.

Первичные конечные точки

• Recruitment rate (number recruited per month) [Срок оценки: 6 months]
• Retention rate (proportion that complete the 6-month trial) [Срок оценки: 6 months]
• Technical feasibility (percentage of screened population) [Срок оценки: 6 months]
• Mean overall usability score obtained from the Health-ITUES [Срок оценки: Assessed at the end of the 6 month trial]
• Average app usage per day [Срок оценки: 6 months]
• Adherence to app reminders (proportion of app reminders) [Срок оценки: 6 months]

Вторичные конечные точки (1)

• Change in ACT score from baseline to the 6-month end point [Срок оценки: Baseline and 6 month end-point]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Оценка устройства

Центры проведения

США · 1 центр

• University of South Florida — Tampa

Идентификаторы

NCT: NCT05572177 · STUDY000956 · R34HL145442

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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