Trial of a Cognitive Intervention for Older Adults
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 2,832
- 试验地点
- 13
- 主要终点
- Changes in Cognitive Abilities of Speed of Processing From Baseline to Year 10
研究概览
简要总结
The purpose of the ACTIVE study was to test if cognitive training interventions could maintain functional independence in elders by improving basic mental abilities, with follow-up assessments through five years.
详细描述
ACTIVE was a 4-arm, single-blind, randomized controlled trial. The primary objective of ACTIVE was to test the effectiveness and durability of three distinct cognitive interventions in improving elders' performance on basic measures of cognition and measures of cognitively demanding daily activities (e.g., food preparation, driving, medication use, financial management). These interventions previously had been found successful in improving cognitive abilities under laboratory or small-scale field conditions.
The three interventions shared common design features: 1) equivalent intensity and duration; 2) small group settings in ten 60-75 minute sessions; 3) focus on strategies for solving problems, remembering, or responding quickly to information; 4) modeling and demonstration of strategy usage; 5) practice on exemplar problems; 6) individual and group exercises; 7) feedback on performance; 8) fostering of self-efficacy regarding performance; 9) applying strategies to real-world tasks; 10) individualized training experiences, and 11) social interaction activities. In all three interventions, Sessions 1-5 focused on strategy instruction and exercises to practice the strategy. Sessions 6-10 provided additional practice exercises, but no new strategies were introduced. Content for each of the 10 sessions was scripted in a trainer's manual.
Interventions:
- Reasoning training focused on inductive reasoning, the ability to solve problems that follow a serial pattern and manifest in executive functioning. Participants were taught strategies to identify the pattern or sequence required to solve a problem. Training exercises involved identifying patterns in both laboratory-type reasoning tasks and in everyday activities, e.g., understanding the pattern in a bus schedule.
- Memory training focused on verbal episodic memory, which deals with acquisition and retrieval of information acquired in a particular place at a particular time. Participants were taught mnemonic strategies for remembering lists and sequences of items, text material, and main ideas and details of stories and other text-based information. Training exercises involved recalling laboratory-like episodic memory tasks as well as tasks related to everyday activities such as recalling a shopping list.
- Speed training focused on visual search and the ability to identify and locate visual information quickly in a divided attention format, with and without distractors. Participants practiced speeded tasks on a computer, and were allowed to proceed to more complex tasks, and faster and faster presentation speeds at their own pace.
- A control group received no training.
In addition, booster training was provided to help participants maintain gains made from initial training and to further improve cognitive skills. Booster training was provided to a random sample of approximately 50% of training participants at 11 and 35-36 months after primary training.
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 (Participant)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 65 or older
- •Mini-Mental State Examination (MMSE) score 23 or greater
- •Vision scored greater than 20/50
- •Minimal dependence in hygiene, bathing, and dressing
排除标准
- •Significant decline in cognitive skills, physical abilities, or functional independence
- •Inability to complete study activities as evidenced by MMSE and vision scores lower than Inclusion Criteria requirement
- •Diagnosis of Alzheimer's disease
- •Stroke in previous 12 months
- •Cancer with limited life expectance
- •Current chemotherapy or radiation treatment
- •Communication problems
- •Planned move from study area
- •Scheduling conflicts that would preclude participation in study activities
- •Prior involvement in similar cognitive training studies
结局指标
主要结局
Changes in Cognitive Abilities of Speed of Processing From Baseline to Year 10
时间窗: Up to 10 years
Speed of processing outcome was computed as the summation of three Useful Field of View tasks requiring identification and localization of information, with 75% accuracy, under varying levels of cognitive demand. For the analysis, the reversed score was used and the possible range of the reversed speed of processing outcome is 0 to 1500. Higher values for the reversed scores represent a better outcome. Changes in outcome were computed as "10 year minus baseline" and the negative values indicate the decline from baseline.
Changes in Cognitive Abilities of Memory From Baseline to Year 10
时间窗: Up to 10 years
Memory outcome was computed as the summation of Rey Auditory-Verbal Learning Test (AVLT), the Hopkins Verbal Learning Test (HVLT), and the Rivermead Behavioral Paragraph Recall test immediate recall. The possible range of the memory outcome is 0 to 132. Higher values represent a better outcome. Changes in outcome were computed as "10 year minus baseline" and the negative values indicate the decline from baseline.
Changes in Everyday Problem Solving From Baseline to Year 10
时间窗: Up to 10 years
Everyday Problem Solving was computed as the summation of the Everyday Problems Test (EPT) and Observed Tasks of Daily Living (OTDL). The possible range of the everyday problem solving outcome is 0 to 56. Higher values represent a better outcome. Changes in outcome were computed as "10 year minus baseline" and the negative values indicate the decline from baseline.
Changes in Cognitive Abilities of Reasoning From Baseline to Year 10
时间窗: Up to 10 years
Reasoning outcome was computed as the summation of total correct for Letter Series, Letter Sets, and Word Series. The possible range of the reasoning outcome is 0 to 75. Higher values represent a better outcome. Changes in outcome were computed as "10 year minus baseline" and the negative values indicate the decline from baseline.
Changes in Everyday Speed of Processing From Baseline to Year 10
时间窗: Up to 10 years
Everyday Speed of processing was computed as the summation of Complex Reaction Time (CRT) and Timed IADL (TIADL). For the analysis, the reversed score was used and the possible range of the reversed everyday speed of processing outcome is -3 to 100. Higher values for the reversed scores represent a better outcome. Changes in outcome were computed as "10 year minus baseline" and the negative values indicate the decline from baseline.
Changes in Instrumental Activities of Daily Living (IADL) Difficulty From Baseline to Year 10
时间窗: Up to 10 years
The self-reported measure of everyday IADL function was the summation of the IADL difficulty sub-scores from the Minimum Dataset - Home Care (MDS-HC) which assesses performance in the past 7 days on 19 daily tasks spanning meal preparation, housework, finances, health care, telephone, shopping, travel, and need for assistance in dressing, personal hygiene, and bathing. For the analysis, the reversed score was used and the possible range of the reversed everyday IADL function outcome is 0 to 38. Higher values for the reversed scores represent a better outcome. Changes in outcome were computed as "10 year minus baseline" and the negative values indicate the decline from baseline.
次要结局
- Examine Health, Genetic and Cognitive Moderators(10th Year)
- Estimate the Effects of ACTIVE Training to General Population(10th Year)
- Changes in Health-related Quality of Life (HRQol), Driving Function, Health Service Use(10th Year)