Evaluation of the Effectiveness of Smartconsent to Improve Understanding of Informed Consent in Prostate Laser Enucleation Procedures
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 52
- 试验地点
- 4
- 主要终点
- Score in the Multiple choice test questionnaire
研究概览
简要总结
The general objective of the study is to assess whether the new smartconsent tool improves patients' understanding of the intervention to be performed, compared to standard practice.
A randomized clinical trial will be conducted in 50 patients who will undergo LASER PROSTATIC ENUCLEATION.
详细描述
Male patients aged between 50 and 70 years, belonging to the Hospital Universitario Araba who are going to undergo PROSTATIC LASER ENUCLEATION, and who attend urology consultation between December 2019 and December 2020, and who meet the inclusion criteria and none of the exclusion criteria.
Inclusion criteria:
- Patients willing to receive information via tablet.
- Patients who know how to and can read.
Exclusion criteria:
-Not applicable.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients willing to receive information via tablet.
- •Patients who know and can read.
排除标准
- •Not applicable
结局指标
主要结局
Score in the Multiple choice test questionnaire
时间窗: At the recruitment moment
Specifically designed for each type of procedure, following the recommendations proposed by Kehoe, Jerard and Fathelrahman et al. and developed on the basis of the information to be provided in an informed consent form, with 4 response options and only one correct answer
次要结局
- Satisfaction with the informed consent proccess(At the recruitment moment)
- Overall satisfaction with the informed consent process,(At the recruitment moment)
- Time required to complete the informed consent process (MIN).(At the recruitment moment)
- Ability to complete the informed consent form(At the recruitment moment)
- Score in the System Usability Scale(At the recruitment moment)