A Mixed Methods, Observational, Cross-over Study of Measurement Comparability and Usability of Electronic and Paper Formats of a Binge Eating Diary
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- The primary endpoint is the comparison of number of binge eating episodes recorded over a 14-day period between diary formats
研究概览
简要总结
The purpose of this study is to examine how binge eating episodes are recorded using two different diary formats: a paper diary and an electronic diary and to see whether both formats collect information in the same way and to understand which of the two formats is easier to use
详细描述
Binge eating (BE) diary has already been successfully employed to measure binge eating behavior in clinical trials. This has been implemented using a paper diary (p-diary) completed daily in the evening. From the diary records, binge eating episodes are confirmed by a healthcare professional. Despite the advantages of electronic implementation and the clinical and research need for such a tool, no electronic diary (e-diary) has been systematically tested in comparison to paper diary through an empirical study.
The following scientific questions are to be answered with this project
- Are the paper and electronic diary formats considered measurement comparable, such that data collected using the different formats across different studies or programs could be directly comparable?
- Are there differences in usability that might limit completion rates or lead to under reporting using one or the other mode of data collection?
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Binge Eating Disorder based on The Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) (5) criteria (as assessed with BED module of the structural clinical interview [SCID] (6) for DSM-5)
- •Reported frequency of minimum of 2 binge episodes/week
- •Age: over 18 years of age
- •Ability to understand and complete self-reporting measures 5 . The subject owns a smartphone compatible with Google Play or Apple App Store and is able to download and use apps appropriately.
排除标准
- •Comorbid psychiatric conditions requiring immediate hospitalization (as assessed with MSE)
- •IInability to use smartphone or paper diary due to physical limitations or technical barriers (e.g., severe visual impairment)
- •Inability to read/write in English
结局指标
主要结局
The primary endpoint is the comparison of number of binge eating episodes recorded over a 14-day period between diary formats
时间窗: from enrollment v1,day 0 to v3,day 30
The primary endpoint is the comparison of number of binge eating episodes recorded over a 14-day period between diary formats
次要结局
未报告次要终点