Desktop vs. Mobile Data Collection in a Prospective Multicenter Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Evaluation score
研究概览
简要总结
Paper-based data collection for prospective clinical trials is associated with a poor quality of data collection. This typically involves missing or wrong data entry or a low recruitment rate, mainly due to the cumbersome and uncontrolled data collection.
Electronic data collection is associated with improved quality of data entry in the cases of Electronic Patient Records (EPR) and patient handover among doctors during night and day shifts. However, a comprehensive direct comparison between web-based desktop personal computer (PC) and mobile (e.g. iPad) data collection has not yet been reported.
The purpose of this prospective trial is to compare the users' experience with the web-based desktop PC and mobile data collection (iPad) tools.
详细描述
The investigators designed a prospective randomized controlled trial where doctors from several randomly selected hospitals will use either a desktop PC or mobile (iPad) data collection tool. A validated user experience evaluation instrument will be used at the beginning, during interim analysis and at the end of the trial.
The desktop-based data collection is built on Drupal, a renowned open source content management system (CMS). The same CMS will be used with a special interface designed for iOS/iPad. Both data collection platforms will be used in parallel to a prospective clinical trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Emergency Room doctors
- •Agree to participate in the trial
- •Provide informed consent
- •Have basic information technology literacy
- •Agree to receive brief training of the platform
排除标准
- •Clinicians and health care professionals not part of this trial
- •Lacking of basic information technology literacy
研究组 & 干预措施
Desktop PC
Conventional institutional Desktop Personal Computers will be used to collect data of patients via a password protected encrypted interface.
干预措施: Evaluation form (Other)
Mobile
Novel Mobile Clinical Trial Management System on iPads will be used to collect data of patients via a password protected encrypted interface.
干预措施: Evaluation form (Other)
结局指标
主要结局
Evaluation score
时间窗: 2 years
A validated user experience and evaluation instrument will be used. The overall score will be compared between the Desktop PC and Mobile (iPad) data collection tools. PC: indicates Personal Computer
次要结局
- Recruitment rate(2 years)
- Cost-effectiveness analysis(2 years)
- Cost-benefit analysis(2 years)
- Cost-utility analysis(2 years)