Preventing Cognitive and Functional Decline Among Seniors at Risk: A Community-Based Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 232
- 试验地点
- 1
- 主要终点
- Changes in improved performance (measured as total number of untrained goals improved to criterion) on the Canadian Occupational Performance Measure (COPM) immediately post-intervention.
研究概览
简要总结
This study evaluates the efficacy of Real-World Strategy Training (RWST) compared to a psycho-education workshop for improving everyday life performance in older adults with subjective cognitive decline (SCD). Participants will be randomly assigned to receive one of these approaches.
详细描述
Evidence suggests that 25-50% of community-dwelling older adults report SCD and that these individuals have an elevated risk for developing Mild Cognitive Impairment and/or dementia. Many of these individuals report difficulties with complex activities of daily living.
RWST aims to reduce these difficulties in everyday life by providing a meta-cognitive training approach that compensates for age-related executive changes. The approach is provided within the context of individually identified everyday-life difficulties.
The psycho-education approach is a Brain-Health Workshop supplemented by intellectually stimulating activities such as doing Sudoku and/or word searches. This approach provides information people may use to inform health behaviour changes.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 60 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Have subjective cognitive complaints
- •Be fluent in written and spoken English
- •Able to self-identify areas of their everyday lives in which they would like to improve.
排除标准
- •Diagnosis of neurological conditions (e.g. dementia, mild cognitive impairment, Parkinson's)
- •Presence of severe depression
- •Presence of substance abuse
- •History of hospitalization for psychiatric reasons
研究组 & 干预措施
Real World Strategy Training
Group intervention including education and strategy training to manage everyday functional difficulties.
干预措施: Real World Strategy Training (Behavioral)
Psychosocial Education
Group sessions including education on brain health.
干预措施: Psychosocial Education (Behavioral)
结局指标
主要结局
Changes in improved performance (measured as total number of untrained goals improved to criterion) on the Canadian Occupational Performance Measure (COPM) immediately post-intervention.
时间窗: Changes from baseline to post-intervention at 10 weeks.
The COPM is a standardized semi-structure interview in which participants identify everyday life difficulties (defined as things they need to or want to do). These issues are converted to goals with performance rated on a 10-point Likert-type scale. Goals considered improved to criterion are those that have a 2 or more points increase on ratings.
次要结局
- Improved performance on the Multiple Errands Test (MET).(10 weeks after baseline (after intervention), 3 months post-intervention, 6 months post-intervention.nths post-intervention.)
- Improved performance on the Canadian Occupational Performance Measure (COPM) measured at three and six months post-intervention.(Three and six months post-intervention.)
- Improved performance on neuropsychological measures of executive function.(Baseline, 10 weeks, 3 months post-intervention, 6 months post-intervention.)
- Improved satisfaction with performance on trained and untrained goals identified using the COPM.(10 weeks after baseline (after intervention), 3 months post-intervention, 6 months post-intervention.)
- Change in health-related Quality of Life(Baseline, 10 weeks, 3 months post-intervention, 6 months post-intervention.)
研究者
Dr. Deirdre Dawson
Senior Scientist
Baycrest