Computerized Cognitive Intervention in the Oldest-Old: A Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 69
- 试验地点
- 2
- 主要终点
- Change in Global Cognition Composite
研究概览
简要总结
Little is known about preventive strategies with immediate public health impact for cognitive functioning in the oldest-old (OO). Cognitive training improves cognitive functioning in the young-old (YO; 60 to 84), yet has not been examined in the OO.
Clinical trials are needed to determine if computerized cognitive training is effective at preventing or delaying cognitive decline in the OO. In order to develop such trials, information regarding use of computers and internet by the OO, and the ability and interest in such a program, must be determined.
This study will examine the effects of a computerized cognitive training program, CogniFit™, with a "classic" computerized games program, on cognitive functioning in cognitively healthy OO subjects. Information regarding use of computers and internet by the OO will be collected. Interest in and ability to complete a computerized cognitive training program will be examined, along with the cognitive, demographic, biological, and lifestyle characteristics related to this interest and ability.
Efficacy of the CogniFit™ and games programs will be assessed immediately following the training and four months after completing the training. The researchers expect that those who use the CogniFit™ program will have greater improvements than those using the games program. Finally, the participants' characteristics related to the efficacy of the programs will be examined.
Subjects recruited for this project will include those already participating in several studies of aging and cognition at the Mount Sinai School of Medicine. Recruiting from this pool of subjects will provide this program with baseline information regarding numerous subject characteristics, including cognition, family history, lifestyle, and cardiovascular information.
This study will inform future large-scale clinical trials of computerized cognitive training programs in the elderly, as well as provide information regarding the efficacy of such training in the OO. In addition, the study will identify characteristics affecting efficacy of computerized training, and thus, may suggest mechanisms through which cognitive training improves cognitive functioning in the most senior citizens of our society.
详细描述
Specific Aim 1- To estimate, in cognitively normal OO, rates of 1) computer and internet use, 2) willingness to participate in a computerized cognitive training program, 3) ability to comply with the program to its completion.
Specific Aim 1a- To explore the relationships of baseline global cognition, sociodemographic, ADL/IADL, lifestyle, and biological characteristics with willingness to participate in, and with completion of a computerized cognitive training program.
Specific aim 2 - To compare the effectiveness of the CogniFit. and games programs 2 months after initiation of the intervention (corresponding to the time to complete the intervention).
Specific aim 2a - To compare the effectiveness of the CogniFit. and games programs 6 months after initiation of intervention Specific aim 3- To explore the relevance of the wide range of already available sociodemographic, lifestyle, ADL/IADL, and biological characteristics of subjects with the differential effectiveness of the programs.
Results of this study will provide essential information for planning a large-scale trial of computerized cognitive training program for the OO.
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
- Double (Participant, Investigator)
盲法说明
Participants are not told which group they are assigned to, and the investigator (PI) and coordinators completing the cognitive evaluation are not told which group the participants are assigned to.
入排标准
- 年龄范围
- 80 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Normal cognition by consensus conference, MMSE> 25th percentile norm, CDR=0
- •Has computer with internet access that is capable of running the computerized cognitive training program.
- •Willing to dedicate the necessary time to the project
排除标准
- •Prior or current participation in another cognitive intervention study
- •Medical disease that precludes consistent participation or that affects cognition
- •Poor vision
- •Poor hearing
研究组 & 干预措施
Computerized cognitive training
Received the Computerized cognitive training program, CogniFit™
干预措施: CogniFit™ (Behavioral)
Control-games
Received the Computerized games program
干预措施: Control-games (Behavioral)
结局指标
主要结局
Change in Global Cognition Composite
时间窗: Baseline and after completion of program (approximately 7-8 weeks)
Memory, Immediate recall; Word List Memory, Delayed recall; Word List Memory, Recognition; Logical Memory Story A, Immediate recall; Logical Memory Story A, Delayed recall; Logical Memory Story A, Recognition, Target Cancellation Tests (diamond and TMX); Trail Making Test (Parts A and B); Digit Symbol Substitution Test; Digit Span tests (Forward and Backward), Similarities; Boston Naming Test; and Category Fluency and Letter Fluency tests at completion of program as compared to baseline.
次要结局
- Change in Logical Memory Story A(Baseline and after completion of program (approximately 7-8 weeks))
- Change in Memory Function(Baseline and after completion of program (approximately 7-8 weeks))
- Change in Attention/Executive function score(Baseline and after completion of program (approximately 7-8 weeks))
- Change in Language function score(Baseline and after completion of program (approximately 7-8 weeks))