An Observational, Retrospective, Single-arm, Open US and Israel Study , for Usability Assessment and Algorithm, Development of the Cordio HearO™ Systeam
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 216
- 试验地点
- 6
- 主要终点
- Patient Usability success defined as: 1.Total and individual usability score of ≥3 in the usability questionnaire in ≥80% of the users.
研究概览
简要总结
To determine the usability and technical aspects of Cordio HearO™
详细描述
The system (including App and server) will be tested under simulated use conditions with representative users to identify potential changes required to the application user interface, to improve user performance and satisfaction, and to inform future design options.
The recordings data will also be used for algorithm improvement
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 22 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Patient Usability success defined as: 1.Total and individual usability score of ≥3 in the usability questionnaire in ≥80% of the users.
时间窗: 2 years
The used scale is: Usability questionnaire for the Cordio HearO™ App. This Usability questionnaire is a subjective evaluation based on Likert score of device user satisfaction. Maximum value for each item: 5 Minimum value for each item: 1 Higher scores means a better outcome
Patient Usability success defined as: 2. Total Compliance
时间窗: 2 Years
The total compliance will be determined by the total number of recording days. Success will be considered if total average compliance of 70 % of all days.
次要结局
未报告次要终点