Elucidating the Necessary Components and Mechanisms of Cognitive Training
试验速览
- 阶段
- 不适用
- 入组人数
- 280
- 试验地点
- 1
- 主要终点
- Protocol compliance
研究概览
简要总结
Loss of independence, cognitive decline, and difficulties in everyday function are areas of great concern for older adults and their families. Cognitive training is one low cost, noninvasive training intervention that has repeatedly demonstrated reliable transfer effects to maintained cognition, everyday function, health, and most recently, a 29% reduction in incident dementia. Importantly, many of these everyday function effects are maintained across five to ten years including: maintained driving mobility, 50% reduction in at-fault vehicle crashes, and maintained Instrumental Activities of Daily Living (IADL). Although clearly an important and effective intervention, the moderators and mechanisms underlying this program are unknown.
The overall objective in this planning grant is to lay the conceptual and methodological foundation to explore cognitive, psychosocial, lifestyle behaviors, and biomarker mechanisms and moderators of two forms of conceptually driven cognitive training. Additionally, this study will examine how cognitive and psychosocial factors within daily life account for the transfer of cognitive training to everyday function. We will use a factorial design to randomize adults ages 55-85 to 0, 10, 20, 30, or 40 hours of two forms of cognitive training, a combined training, or an active comparison condition (Phase 1). An additional sample of participants will complete 20 hours of two forms of cognitive training or the active comparison group as well as provide blood samples (Phase 2).
Across the study period, participants will complete cognitive, health, lifestyle, and psychosocial assessments at baseline, posttest, and approximately three month follow-up assessments in person or remotely using a study-provided laptop. Additionally, all participants will be asked to complete daily cognitive, health, lifestyle, and psychosocial measures daily using study-provided smartphones.
This study will allow us to test the feasibility of our enrollment, assessment and training protocols for a future multisite clinical trial. This exploratory study is the first of its kind and will be used to provide important data relevant to a future larger randomized controlled trial examining mediators of cognitive training in a representative sample of adults. This information will assist in the future development of more effective home- and community-based interventions that maintain everyday function.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 55-85 community-dwelling adults
- •Written informed consent obtained
- •No reported evidence of or diagnosis of dementia/Alzheimer's Disease; score of 5 or greater on the MIS-t administered during phone screening
- •Willing and able to participate in the up to 9 months of the study duration
- •Is proficient in written and spoken English
- •All Phase 1 criteria plus willingness and ability to provide two blood samples at baseline and posttest
排除标准
- •Phase 1 exclusions:
- •Failure to meet any of the above eligibility criteria
- •Use of video games for more than 2 hours/week over the previous 2 years
- •Currently engaged in a cognitive program such as Brain HQ or Lumosity
- •Phase 2 exclusion:
- •In addition to Phase 1 exclusion, also criteria below:
- •Inability or unwillingness to travel to Clemson to provide two in-person blood samples at baseline and posttest
研究组 & 干预措施
BUD1
10 hours of bottom-up driven cognitive training games
干预措施: BUD1 (Behavioral)
BUD2
10 hours of bottom-up driven cognitive training games
干预措施: BUD2 (Behavioral)
No contact
0 hours of activities during intervention period of study
TDD1
10 hours of top-down driven cognitive training games
干预措施: TDD1 (Behavioral)
TDD2
10 hours of top-down driven cognitive training games
干预措施: TDD2 (Behavioral)
TDD1 + TDD2
20 hours of top-down driven cognitive training games
干预措施: TDD1 (Behavioral)
TDD1 + TDD2
20 hours of top-down driven cognitive training games
干预措施: TDD2 (Behavioral)
BUD1 + BUD2
20 hours of bottom-up driven cognitive training games
干预措施: BUD1 (Behavioral)
BUD1 + BUD2
20 hours of bottom-up driven cognitive training games
干预措施: BUD2 (Behavioral)
BUD2 + TDD2
10 hours of bottom-up driven cognitive training games plus 10 hours of top-down driven cognitive training games
干预措施: BUD2 (Behavioral)
BUD2 + TDD2
10 hours of bottom-up driven cognitive training games plus 10 hours of top-down driven cognitive training games
干预措施: TDD2 (Behavioral)
BUD1 + TDD1
10 hours of bottom-up driven cognitive training games plus 10 hours of top-down driven cognitive training games
干预措施: BUD1 (Behavioral)
BUD1 + TDD1
10 hours of bottom-up driven cognitive training games plus 10 hours of top-down driven cognitive training games
干预措施: TDD1 (Behavioral)
BUD2 + TDD1
10 hours of bottom-up driven cognitive training games plus 10 hours of top-down driven cognitive training games
干预措施: BUD2 (Behavioral)
BUD2 + TDD1
10 hours of bottom-up driven cognitive training games plus 10 hours of top-down driven cognitive training games
干预措施: TDD1 (Behavioral)
BUD2 + TDD1 + TDD2
10 hours of bottom-up driven cognitive training games plus 20 hours of top-down driven cognitive training games
干预措施: BUD2 (Behavioral)
BUD2 + TDD1 + TDD2
10 hours of bottom-up driven cognitive training games plus 20 hours of top-down driven cognitive training games
干预措施: TDD1 (Behavioral)
BUD2 + TDD1 + TDD2
10 hours of bottom-up driven cognitive training games plus 20 hours of top-down driven cognitive training games
干预措施: TDD2 (Behavioral)
CSA10
10 hours of cognitive stimulating activities
干预措施: CSA10 (Behavioral)
BUD1 + TDD2
10 hours of bottom-up driven cognitive training games plus 10 hours of top-down driven cognitive training games
干预措施: BUD1 (Behavioral)
BUD1 + TDD2
10 hours of bottom-up driven cognitive training games plus 10 hours of top-down driven cognitive training games
干预措施: TDD2 (Behavioral)
BUD1 + TDD1 + TDD2
10 hours of bottom-up driven cognitive training games plus 20 hours of top-down driven cognitive training games
干预措施: BUD1 (Behavioral)
BUD1 + TDD1 + TDD2
10 hours of bottom-up driven cognitive training games plus 20 hours of top-down driven cognitive training games
干预措施: TDD1 (Behavioral)
BUD1 + TDD1 + TDD2
10 hours of bottom-up driven cognitive training games plus 20 hours of top-down driven cognitive training games
干预措施: TDD2 (Behavioral)
BUD1 + BUD2 + TDD2
20 hours of bottom-up driven cognitive training games plus 10 hours of top-down driven cognitive training games
干预措施: BUD1 (Behavioral)
BUD1 + BUD2 + TDD2
20 hours of bottom-up driven cognitive training games plus 10 hours of top-down driven cognitive training games
干预措施: BUD2 (Behavioral)
BUD1 + BUD2 + TDD2
20 hours of bottom-up driven cognitive training games plus 10 hours of top-down driven cognitive training games
干预措施: TDD2 (Behavioral)
BUD1 + BUD2 + TDD1
20 hours of bottom-up driven cognitive training games plus 10 hours of top-down driven cognitive training games
干预措施: BUD1 (Behavioral)
BUD1 + BUD2 + TDD1
20 hours of bottom-up driven cognitive training games plus 10 hours of top-down driven cognitive training games
干预措施: BUD2 (Behavioral)
BUD1 + BUD2 + TDD1
20 hours of bottom-up driven cognitive training games plus 10 hours of top-down driven cognitive training games
干预措施: TDD1 (Behavioral)
BUD1 + BUD2 + TDD1 + TDD2
20 hours of bottom-up driven cognitive training games plus 20 hours of top-down driven cognitive training games
干预措施: BUD1 (Behavioral)
BUD1 + BUD2 + TDD1 + TDD2
20 hours of bottom-up driven cognitive training games plus 20 hours of top-down driven cognitive training games
干预措施: BUD2 (Behavioral)
BUD1 + BUD2 + TDD1 + TDD2
20 hours of bottom-up driven cognitive training games plus 20 hours of top-down driven cognitive training games
干预措施: TDD1 (Behavioral)
BUD1 + BUD2 + TDD1 + TDD2
20 hours of bottom-up driven cognitive training games plus 20 hours of top-down driven cognitive training games
干预措施: TDD2 (Behavioral)
CSA20
20 hours of cognitive stimulating activities
干预措施: CSA20 (Behavioral)
CSA30
30 hours of cognitive stimulating activities
干预措施: CSA30 (Behavioral)
CSA40
40 hours of cognitive stimulating activities
干预措施: CSA40 (Behavioral)
结局指标
主要结局
Protocol compliance
时间窗: Baseline through 3 month follow-up visit
Participants complete laptop and phone activities as outlined in the study protocol
次要结局
- Complex Instrumental Activities of Daily Living(Baseline through 3 month follow-up visit)