Clinical trial NCT03141281: Intervention Comparative Effectiveness for Adult Cognitive Training
Official title: Intervention Comparative Effectiveness for Adult Cognitive Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Aging
Keywords: aging
cognitive ability
IADL
driving
financial fraud
perception
attention
memory
Lead sponsor: Florida State University
Sponsor class: OTHER
First posted: 2017-05-05
Enrollment: 238
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Random assignment to one of four treatment groups at study entry
Primary purpose: BASIC_SCIENCE

Brief summary: The study will compare the effect of broad and directed (narrow) technology-based training on basic perceptual and cognitive abilities in older adults and on the performance of simulated tasks of daily living including driving and fraud avoidance.

Detailed description: Participants will be randomly assigned to four training conditions: broad training using either 1) Posit Science's web-based "BrainHQ" or 2) the video game Rise of Nations, or to directed training for 3) Instrumental Activities of Daily Living (IADL) training on both driving, American Association of Retired Persons (AARP)'s web-based older driver training program, and training for fraud avoidance, a web-based tutorial on finance and fraud, or 4) to an active control condition of puzzle solving. Training will take approximately 15-20 hr for each treatment condition. Before training begins, participants will take baseline ability tests of perception, attention, memory, and cognition, activities of daily living, as well as a driving simulator test for hazard perception, and a financial fraud recognition test. They will be tested again on these measures following training completion, and at a one-year follow-up from training completion.

Eligibility criteria: Inclusion Criteria:

* Age 65 years and above
* Plans to stay in the Tallahassee, Leon County area for the next year
* Valid driver's license and drives at least once a month
* Adequate cognitive ability assessed via telephone interview using the Wechsler Memory Scale III with story A score \>6 or story B score \>4.

Exclusion Criteria:

* Terminal illness with life expectancy less than 12 months
* Reports or exhibits a disabling visual condition assessed as the inability to read printed material
* Reports or exhibits a disabling speech hearing and comprehension condition assessed by inability to hear and comprehend the screener's instructions
* Reports or exhibits a disabling speech production condition assessed as the inability to respond with comprehensible English speech to the screener's queries
* Reports or exhibits a disabling psychomotor condition assessed as the inability to use a keyboard and pointing device
* Has completed the AARP driver training course
* Has played the Rise of Nations video game
* Has trained with Posit Science's "BrainHQ"
* Has trained on the Mind Frontiers video game.

Primary outcomes:
measure: Fraud Detection Post Training
timeFrame: Baseline, Immediately after 4-week intervention training
measure: Driving Simulator Hazard Perception Post Training
timeFrame: Baseline, Immediately after 4-week intervention training
measure: Self-reported Difficulty With Instrumental Activities of Daily Living (IADLs) Post Training
timeFrame: Baseline, Immediately after 4-week intervention training
measure: Speed of Processing Post Training
timeFrame: Baseline, Immediately after 4-week intervention training
measure: Knowledge About Driving Post Training
timeFrame: Immediately after 4-week intervention training
measure: Knowledge About Finances and Fraud Post Training
timeFrame: Immediately after 4-week intervention training
measure: Fraud Detection at One Year
timeFrame: Baseline, One-year after 4-week intervention training
measure: Driving Simulator Hazard Perception at One Year
timeFrame: Baseline, One-year after 4-week intervention training
measure: Self-reported Difficulty With Instrumental Activities of Daily Living (IADLs) at One Year
timeFrame: Baseline, One-year after 4-week intervention training
measure: Speed of Processing at One Year
timeFrame: Baseline, One-year after 4-week intervention training
measure: Knowledge About Driving at One Year
timeFrame: One-year after 4-week intervention training
measure: Knowledge About Finances and Fraud at One Year
timeFrame: One-year after 4-week intervention training
measure: Driving Simulator Average Speed Post Training
timeFrame: Baseline, Immediately after 4-week intervention training
measure: Driving Simulator Max Brake Compression Post Training
timeFrame: Baseline, Immediately after 4-week intervention training
measure: Driving Simulator Average Lane Position Post Training
timeFrame: Baseline, Immediately after 4-week intervention training
measure: Driving Simulator Average Speed at One Year
timeFrame: Baseline, One-year after 4-week intervention training
measure: Driving Simulator Max Brake Compression at One Year
timeFrame: Baseline, One-year after 4-week intervention training
measure: Driving Simulator Average Lane Position at One Year
timeFrame: Baseline, One-year after 4-week intervention training
measure: Useful Field of View Post Training
timeFrame: Baseline, Immediately after 4-week intervention training
measure: Digit Symbol Substitution Test Post Training
timeFrame: Baseline, Immediately after 4-week intervention training
measure: Useful Field of View at One Year
timeFrame: Baseline, One-year after 4-week intervention training
measure: Digit Symbol Substitution Test at One Year
timeFrame: Baseline, One-year after 4-week intervention training
Secondary outcomes:
measure: Technology Proficiency Post Training
timeFrame: Baseline, Immediately after 4-week intervention training
measure: Technology Proficiency at One Year
timeFrame: Baseline, One-year after 4-week intervention training
measure: Numeracy Post Training
timeFrame: Baseline, Immediately after 4-week intervention training
measure: Numeracy at One Year
timeFrame: Baseline, One-year after 4-week intervention training
measure: Reasoning Ability Post Training
timeFrame: Baseline, Immediately after 4-week intervention training
measure: Reasoning Ability at One Year
timeFrame: Baseline, One-year after 4-week intervention training
measure: Memory Ability Post Training
timeFrame: Baseline, Immediately after 4-week intervention training
measure: Memory Ability at One Year
timeFrame: Baseline, One-year after 4-week intervention training
measure: Miami Instrumental Activities of Daily Living Task Post Training
timeFrame: Baseline, Immediately after 4-week intervention training
measure: Miami Instrumental Activities of Daily Living Task at One Year
timeFrame: Baseline, One-year after 4-week intervention training
Other outcomes:
Locations:
city: Tallahassee
country: United States
facility: Florida State University
state: Florida
Study officials:
affiliation: Florida State University
name: Neil Charness, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Florida State University
name: Walter Boot, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Gray N, Yoon JS, Charness N, Boot WR, Roque NA, Andringa R, Harrell ER, Lewis KG, Vitale T. Relative effectiveness of general versus specific cognitive training for aging adults. Psychol Aging. 2022 Mar;37(2):210-221. doi: 10.1037/pag0000663. Epub 2021 Dec 30.
citation: Yoon JS, Roque NA, Andringa R, Harrell ER, Lewis KG, Vitale T, Charness N, Boot WR. Intervention Comparative Effectiveness for Adult Cognitive Training (ICE-ACT) Trial: Rationale, design, and baseline characteristics. Contemp Clin Trials. 2019 Mar;78:76-87. doi: 10.1016/j.cct.2019.01.014. Epub 2019 Jan 31.