Elucidating the Necessary Active Components of Training (ENACT)
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About
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.
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Inclusion criteria
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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
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Phase 2:
- All Phase 1 criteria plus willingness and ability to provide two blood samples at baseline and posttest
Exclusion criteria
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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
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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
Trial design
Primary purpose
Allocation
Interventional model
Masking
280 participants in 20 patient groups
Trial contacts and locations
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Central trial contact
Jeremy Shields, MS; Lesley Ross, PhD
Data sourced from clinicaltrials.gov
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