Feasibility of MHealth Technology for Improving Self-Management and Adherence Among Asthmatic Adolescents
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Recruitment rate (number recruited per month)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Device Feasibility
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Recruitment rate (number recruited per month)
时间窗: 6 months
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.
Mean overall usability score obtained from the Health-ITUES
时间窗: Assessed at the end of the 6 month trial
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
时间窗: 6 months
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.
Technical feasibility (percentage of screened population)
时间窗: 6 months
The percentage of the screened population that has a suitable smartphone and data plan or wi-fi access in order to use the app.
Adherence to app reminders (proportion of app reminders)
时间窗: 6 months
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.
Retention rate (proportion that complete the 6-month trial)
时间窗: 6 months
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.
次要结局
- Change in ACT score from baseline to the 6-month end point(Baseline and 6 month end-point)