Advancing Cognition and Cognitive Reserve Before ELective Surgery to Enhance Cognitive Recovery And TrajEctories (ACCELERATE)Trial: a Pilot Multicenter Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 103
- 试验地点
- 1
研究概览
简要总结
The Advancing Cognition and Cognitive reserve before ELective surgery to Enhance cognitive Recovery And TrajEctories (ACCELERATE) Pilot Trial estimates whether our novel, coach-supported cognitive prehabilitation strategy will achieve adequate intervention adherence in the context of a feasible multicenter trial protocol.
详细描述
Background: Delirium, a fluctuating, acute disturbance in attention and awareness, develops in 15-50% of older adults after major surgery. Promising, early stage evidence suggests that cognitive prehabilitation could decrease the absolute risk of postoperative delirium by 10% or more. However, multicenter trials that feasibly optimize cognitive prehabilitation adherence amongst populations most likely to benefit from the intervention are required to advance cognitive prehabilitation toward routine practice.
Overarching Aim: The ACCELERATE Pilot Trial will estimate whether our novel, coach-supported cognitive prehabilitation strategy will achieve adequate intervention adherence in the context of a feasible multicenter trial protocol.
Methods:
Design, setting and participants: The ACCELERATE Pilot trial is prospective single-arm interventional pilot trial.
People >/= 60 years old with Clinical Frailty Scale (CFS) score >/= 4 having inpatient abdominal, orthopedic, spine, thoracic, pelvic, head-and-neck, and vascular surgery with expected time to surgery >/= 4 weeks will be included.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age >/= 60 years
- •Planned, inpatient, surgical procedures: abdominal, orthopedic, spine, thoracic, pelvic, ENT, and vascular
- •Clinical Frailty Scale (CFS) score >/= 4
- •Expected time to surgery >/= 4 weeks
- •Cognitive capacity to independently consent for surgery
排除标准
- •Cardiac and intracranial neurosurgery procedures
- •Visual impairment
- •Lack of English fluency
研究组 & 干预措施
Intervention (cognitive prehabilitation)
Home-based, online, adaptive, multidomain cognitive prehabilitation program, using a cognitive training platform (Lumosity [Lumos Labs]), enhanced by theory- and evidence-informed structured coaching.
干预措施: Cognitive Prehabilitation (Behavioral)