Cognitive Monitoring in Planned Arthroplasty Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 117
- 试验地点
- 1
- 主要终点
- Number of patients declining
研究概览
简要总结
Feasibility study testing a prospective observational methodology to assess the feasibility of serial remote monitoring of cognition with CogTrack™, an online cognitive assessment tool.
详细描述
A feasibility study testing a prospective observational methodology at two secondary care sites (Derriford Hospital, University Hospitals Plymouth NHS Trust and Torbay Hospital, Torbay and South Devon NHS Foundation Trust) and open to interested primary care practices (who refer patients to secondary care).
Serial cognitive testing will be performed using CogTrack™, a validated online cognitive assessment tool, over approximately an 11-week period. CogTrack™ requires two practice sessions to familiarise participants13, so the baseline CogTrack™ score will be that which is performed on the third occasion. Surgical patients will be tested both pre- and post-operatively. Non-surgical patients will have the assessments done at times to mirror those in the surgical group.
Target is to recruit 150 participants in the surgery group and 50 control patients from primary care.
The demographics and other data will be directly entered onto a secure electronic eCRF by a member of the research team. Only networked trust computers will be used and data entered onto a password protected database held on a shared network drive.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Secondary Care (cases)
- •Age over 60 years
- •Listed for elective hip replacement
- •Listed for elective knee replacement
- •Able to consent for surgery
- •Primary Care (controls) matched population by age
排除标准
- •Patient refusal
- •Operation in the previous 12 months
- •Patients lacking capacity to sign their own consent form for surgery
- •Patients already with a diagnosis of dementia or deemed to lack capacity
- •Operation date within 3 weeks
结局指标
主要结局
Number of patients declining
时间窗: 18 months
Number of patients declining
Number of withdrawals plus reason if given
时间窗: 18 months
Number of withdrawals plus reason if given
Acceptability questionnaire
时间窗: 18 months
Acceptability questionnaire
Number of patients recruited
时间窗: 18 months
Number of patients recruited
Number of patients approached
时间窗: 18 months
Number of patients approached
Completion rate of secondary assessment
时间窗: 18 months
Completion rate of secondary assessments
Completion rate of remote cognitive assessment
时间窗: 18 months
Completion rate of remote cognitive assessment
IT accessibility
时间窗: 18 months
IT accessibility
次要结局
- Short form of the Informant Questionnaire on Cognitive Decline in the Elderly (Short IQCODE)2:(18 months)
- Clock drawing test (semi quantitative, score out of 3):(18 months)
- Pain score:(18 months)
- Opioid and sedative consumption in previous 6 hours:(18 months)
- Mood:(18 months)
- Cognitive assessment(18 months)
- 3D-CAM scores:(18 months)
- Single question of subjective memory deterioration:(18 months)