Elucidating the Necessary Active Components of Training
ENACT
Elucidating the Necessary Components and Mechanisms of Cognitive Training
1 other identifier
interventional
280
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable alzheimer-disease
Started Feb 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 21, 2022
CompletedFirst Submitted
Initial submission to the registry
May 4, 2022
CompletedFirst Posted
Study publicly available on registry
May 9, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2024
CompletedMay 9, 2022
May 1, 2022
1.9 years
May 4, 2022
May 4, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Protocol compliance
Participants complete laptop and phone activities as outlined in the study protocol
Baseline through 3 month follow-up visit
Secondary Outcomes (1)
Complex Instrumental Activities of Daily Living
Baseline through 3 month follow-up visit
Study Arms (20)
No contact
NO INTERVENTION0 hours of activities during intervention period of study
TDD1
EXPERIMENTAL10 hours of top-down driven cognitive training games
TDD2
EXPERIMENTAL10 hours of top-down driven cognitive training games
TDD1 + TDD2
EXPERIMENTAL20 hours of top-down driven cognitive training games
BUD1
EXPERIMENTAL10 hours of bottom-up driven cognitive training games
BUD2
EXPERIMENTAL10 hours of bottom-up driven cognitive training games
BUD1 + BUD2
EXPERIMENTAL20 hours of bottom-up driven cognitive training games
BUD2 + TDD2
EXPERIMENTAL10 hours of bottom-up driven cognitive training games plus 10 hours of top-down driven cognitive training games
BUD1 + TDD1
EXPERIMENTAL10 hours of bottom-up driven cognitive training games plus 10 hours of top-down driven cognitive training games
BUD2 + TDD1
EXPERIMENTAL10 hours of bottom-up driven cognitive training games plus 10 hours of top-down driven cognitive training games
BUD2 + TDD1 + TDD2
EXPERIMENTAL10 hours of bottom-up driven cognitive training games plus 20 hours of top-down driven cognitive training games
BUD1 + TDD2
EXPERIMENTAL10 hours of bottom-up driven cognitive training games plus 10 hours of top-down driven cognitive training games
BUD1 + TDD1 + TDD2
EXPERIMENTAL10 hours of bottom-up driven cognitive training games plus 20 hours of top-down driven cognitive training games
BUD1 + BUD2 + TDD2
EXPERIMENTAL20 hours of bottom-up driven cognitive training games plus 10 hours of top-down driven cognitive training games
BUD1 + BUD2 + TDD1
EXPERIMENTAL20 hours of bottom-up driven cognitive training games plus 10 hours of top-down driven cognitive training games
BUD1 + BUD2 + TDD1 + TDD2
EXPERIMENTAL20 hours of bottom-up driven cognitive training games plus 20 hours of top-down driven cognitive training games
CSA10
ACTIVE COMPARATOR10 hours of cognitive stimulating activities
CSA20
ACTIVE COMPARATOR20 hours of cognitive stimulating activities
CSA30
ACTIVE COMPARATOR30 hours of cognitive stimulating activities
CSA40
ACTIVE COMPARATOR40 hours of cognitive stimulating activities
Interventions
10 hours of bottom-up driven computerized cognitive training designed to improve processing speed and divided attention
10 hours of bottom-up driven computerized cognitive training designed to improve divided attention
10 hours of top-down driven computerized cognitive training designed to improve multiple object tracking
10 hours of top-down driven computerized cognitive training designed to improve executive function
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- Inability or unwillingness to travel to Clemson to provide two in-person blood samples at baseline and posttest
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Clemson Universitylead
- National Institute on Aging (NIA)collaborator
- Penn State Universitycollaborator
- University of Alabama at Birminghamcollaborator
Study Sites (1)
Clemson University Institute for Engaged Aging
Seneca, South Carolina, 29672, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 4, 2022
First Posted
May 9, 2022
Study Start
February 21, 2022
Primary Completion
February 1, 2024
Study Completion
February 1, 2024
Last Updated
May 9, 2022
Record last verified: 2022-05