Prevention of Early Postoperative Decline
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 45
- 试验地点
- 2
- 主要终点
- Feasibility of Providing a Neurocognitive Training Program to Elderly Cardiac Surgical Patients - Enrollment
研究概览
简要总结
The purpose of this trial is to determine whether using a brain training program in the time leading up to as well as after heart surgery will reduce confusion and cognitive loss that can occur after surgery.
详细描述
Randomized, controlled pilot study with a convenience sample of 45 adult cardiac surgical patients. The main intervention to be studied will be the use of a neurocognitive training program (Lumosity) for 10 days preoperatively, and then for four weeks postoperatively. The prescribed regimen of training will focus on the areas of cognitive function most commonly affected in the postoperative period, including working memory, attention, and processing speed. Patients in the control arm will undergo current standard cardiac surgical postoperative care and will be asked to refrain from obtaining a Lumosity account.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients undergoing cardiac surgery age 60-90
- •Cardiac surgery scheduled at least 10 days from enrollment
- •High school education level or equivalent
排除标准
- •Preexisting psychiatric illness
- •History of cerebrovascular event or seizure
- •Non English speakers
- •Baseline severe cognitive dysfunction including Alzheimer's, Parkinson's, or other severe forms of dementia
- •Significant visual impairment
- •Enrollment in another study involving cognition
结局指标
主要结局
Feasibility of Providing a Neurocognitive Training Program to Elderly Cardiac Surgical Patients - Enrollment
时间窗: Enrollment was assessed after enrollment was completed.
Feasibility will be partly determined by evaluating enrollment. Enrolling \>50% of eligible patients is the target.
Feasibility of Providing a Neurocognitive Training Program to Elderly Cardiac Surgical Patients - Adherence
时间窗: To be evaluated at the conclusion of the study. Adherence was assessed in 3 separate periods: pre hospital, in hospital, and post discharge (typically at the 4 week follow up clinic visit).
Feasibility will be partly determined by evaluating adherence patterns. Sufficient adherence to protocol will be deemed sufficient to deem the study feasible.
次要结局
- Number of Participants With Postoperative Delirium Measured by the Confusion Assessment Method (CAM)(Defined as present or absent on any day from postoperative day 1 to postoperative day 7.)
- Number of Participants With Postoperative Cognitive Decline(Day of hospital discharge, an average of 1 week.)
- Postoperative Cognitive Dysfunction Measured Using the Montreal Cognitive Assessment (MoCA)(Measured at 1, 3 and 6 months postoperatively.)
研究者
Brian O'Gara
MD
Beth Israel Deaconess Medical Center