Elucidating the Necessary Active Components of Training
- Conditions
- Cognitive ImpairmentAlzheimer DiseaseCognitive Change
- Interventions
- Behavioral: BUD1Behavioral: TDD2Behavioral: CSA10Behavioral: CSA20Behavioral: CSA30Behavioral: CSA40Behavioral: BUD2Behavioral: TDD1
- Registration Number
- NCT05366023
- Lead Sponsor
- Clemson University
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 280
-
Phase 1:
- 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
-
Phase 2:
- All Phase 1 criteria plus willingness and ability to provide two blood samples at baseline and posttest
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description BUD1 + TDD1 BUD1 10 hours of bottom-up driven cognitive training games plus 10 hours of top-down driven cognitive training games BUD1 + BUD2 + TDD1 BUD2 20 hours of bottom-up driven cognitive training games plus 10 hours of top-down driven cognitive training games BUD1 + TDD2 BUD1 10 hours of bottom-up driven cognitive training games plus 10 hours of top-down driven cognitive training games BUD1 + TDD1 + TDD2 BUD1 10 hours of bottom-up driven cognitive training games plus 20 hours of top-down driven cognitive training games BUD1 + TDD1 + TDD2 TDD1 10 hours of bottom-up driven cognitive training games plus 20 hours of top-down driven cognitive training games BUD1 + BUD2 + TDD2 BUD1 20 hours of bottom-up driven cognitive training games plus 10 hours of top-down driven cognitive training games BUD2 BUD2 10 hours of bottom-up driven cognitive training games BUD1 + TDD1 TDD1 10 hours of bottom-up driven cognitive training games plus 10 hours of top-down driven cognitive training games TDD2 TDD2 10 hours of top-down driven cognitive training games TDD1 + TDD2 TDD2 20 hours of top-down driven cognitive training games BUD2 + TDD2 TDD2 10 hours of bottom-up driven cognitive training games plus 10 hours of top-down driven cognitive training games BUD1 + BUD2 BUD1 20 hours of bottom-up driven cognitive training games BUD2 + TDD1 BUD2 10 hours of bottom-up driven cognitive training games plus 10 hours of top-down driven cognitive training games BUD2 + TDD1 + TDD2 TDD1 10 hours of bottom-up driven cognitive training games plus 20 hours of top-down driven cognitive training games BUD2 + TDD1 + TDD2 TDD2 10 hours of bottom-up driven cognitive training games plus 20 hours of top-down driven cognitive training games BUD1 + BUD2 + TDD1 + TDD2 TDD1 20 hours of bottom-up driven cognitive training games plus 20 hours of top-down driven cognitive training games TDD1 TDD1 10 hours of top-down driven cognitive training games BUD1 + BUD2 BUD2 20 hours of bottom-up driven cognitive training games BUD1 + TDD2 TDD2 10 hours of bottom-up driven cognitive training games plus 10 hours of top-down driven cognitive training games BUD1 + BUD2 + TDD1 + TDD2 BUD2 20 hours of bottom-up driven cognitive training games plus 20 hours of top-down driven cognitive training games TDD1 + TDD2 TDD1 20 hours of top-down driven cognitive training games BUD1 BUD1 10 hours of bottom-up driven cognitive training games BUD2 + TDD2 BUD2 10 hours of bottom-up driven cognitive training games plus 10 hours of top-down driven cognitive training games BUD2 + TDD1 TDD1 10 hours of bottom-up driven cognitive training games plus 10 hours of top-down driven cognitive training games BUD2 + TDD1 + TDD2 BUD2 10 hours of bottom-up driven cognitive training games plus 20 hours of top-down driven cognitive training games BUD1 + BUD2 + TDD2 BUD2 20 hours of bottom-up driven cognitive training games plus 10 hours of top-down driven cognitive training games BUD1 + TDD1 + TDD2 TDD2 10 hours of bottom-up driven cognitive training games plus 20 hours of top-down driven cognitive training games CSA10 CSA10 10 hours of cognitive stimulating activities CSA20 CSA20 20 hours of cognitive stimulating activities CSA30 CSA30 30 hours of cognitive stimulating activities CSA40 CSA40 40 hours of cognitive stimulating activities BUD1 + BUD2 + TDD2 TDD2 20 hours of bottom-up driven cognitive training games plus 10 hours of top-down driven cognitive training games BUD1 + BUD2 + TDD1 BUD1 20 hours of bottom-up driven cognitive training games plus 10 hours of top-down driven cognitive training games BUD1 + BUD2 + TDD1 + TDD2 TDD2 20 hours of bottom-up driven cognitive training games plus 20 hours of top-down driven cognitive training games BUD1 + BUD2 + TDD1 TDD1 20 hours of bottom-up driven cognitive training games plus 10 hours of top-down driven cognitive training games BUD1 + BUD2 + TDD1 + TDD2 BUD1 20 hours of bottom-up driven cognitive training games plus 20 hours of top-down driven cognitive training games
- Primary Outcome Measures
Name Time Method Protocol compliance Baseline through 3 month follow-up visit Participants complete laptop and phone activities as outlined in the study protocol
- Secondary Outcome Measures
Name Time Method Complex Instrumental Activities of Daily Living Baseline through 3 month follow-up visit Measures of everyday functioning as detailed in the study protocol
Trial Locations
- Locations (1)
Clemson University Institute for Engaged Aging
🇺🇸Seneca, South Carolina, United States