Evaluation of the Effectiveness of User-focused Mobile Health Application on Asthma Control and Self-efficacy in Adolescents With Asthma: a Randomized Controlled Trial Protocol
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 4
- 主要终点
- Asthma Control
研究概览
简要总结
Mobile health applications (mHealth apps) are an opportunity offered by developing technology which in widely used among youths. The evidence regarding mHealth apps suggests that the apps can be safer and more feasible if are developed by healthcare team. Healthcare professionals have a major role to play in developing mHealth apps of good interventions.
详细描述
This study aims at developing the mHealth application (YoungAsthma) and evaluating the effectiveness of YoungAsthma app on the mean score of the asthma control test and self-efficacy scale in adolescents with asthma. This study is a self-efficacy theory-based, 4-week, randomized parallel group study. Participants will be randomized to either the intervention or control group in a 1:1 ratio. Adolescents will be randomly allocated to intervention (YoungAsthma which is a user-focused mHealth app) or control group (Usual care). The study protocol is conducted in accord with the Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT 2013 Statement) (Chan et al., 2013), the RCT is perform by the Consolidated Standards of Reporting Trials (CONSORT) (Moher et al., 2010) and the mHealth app is identified according to the mERA guideline (Agarwal et al., 2016).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •Having ability to speak, read and write Turkish at a sufficient level,
- •Having a diagnosis of asthma for at least a year,
- •Having an asthma control test score of 19 or below,
- •Having ability to use mobile devices,
- •Having a mobile device with an internet connection to login to the mHealth App.
排除标准
- •Having an internet access problem,
- •Having a psychiatric medical diagnosis
结局指标
主要结局
Asthma Control
时间窗: Assessment of change of the asthma control from baseline to 4 weeks will be done.
Asthma control will be evaluated by the Asthma Control Test (ACT) (Liu et al., 2007).
Self-Efficacy
时间窗: Assessment of change of the self-efficacy from baseline to 4 weeks will be done.
Self-efficacy will be evaluated by Asthmatic Child and Adolescent Self-Efficacy Scale (ACASES) (Schlösser \& Havermans, 1992).
次要结局
未报告次要终点
研究者
Nimet KARATAS
Research Assistant
Akdeniz University