Intervention Comparative Effectiveness for Adult Cognitive Training

Not Applicable

Completed

Conditions: Cognitive Aging

Interventions: Behavioral: Rise of Nations
Behavioral: Active Control
Behavioral: BrainHQ
Behavioral: IADL Training

Registration Number: NCT03141281

Lead Sponsor: Florida State University

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 238

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rise of Nations	Rise of Nations	Participants will be provided with a laptop computer with the Rise of Nations video game, be trained in game play, and instructed to play the game for 20 hours
Active Control	Active Control	Participants will be provided with a laptop computer and asked to complete 20 hr of training with Sudoku, crossword puzzles, and word search
BrainHQ	BrainHQ	Participants will be provided with a laptop computer and enrolled in a commercial web-based cognitive training program, BrainHQ, trained on how to access it, and instructed to complete a fixed number of sessions in 20 hours.
IADL training	IADL Training	Participants will be enrolled in American Association of Retired Persons' web-based driver training course, trained on how to access it, and asked to complete the course, estimated to take approximately 6-8 hours. They will also be provided with web-based access to a finance and fraud avoidance training tutorial, instructed on how to access it, and be asked to complete the course, estimated to take approximately 5-7 hours. The two courses combined are estimated to take about 15 hours.

Primary Outcome Measures

Name	Time	Method
Driving Simulator Average Lane Position Post Training	Baseline, Immediately after 4-week intervention training	Average lane position in a driving simulator measured at baseline and immediately after 4 weeks of training. Lane position measures the average deviation from the center of a lane while driving (values from -1 to 1), averaged across participants, where 0 represents perfect center, negative scores represent deviation to the left (from 0 to -1), and positive scores represent deviation to the right (from 0 to 1). Lane position indicates vehicle control and safety.
Driving Simulator Average Speed at One Year	Baseline, One-year after 4-week intervention training	Average speed in a driving simulator measured at baseline and one year after 4 weeks of training. Speed is a continuous measure in miles per hour, with a minimum of 0 and no maximum. Speed may indicate risky driving behavior.
Driving Simulator Max Brake Compression at One Year	Baseline, One-year after 4-week intervention training	Maximum brake compression in a driving simulator measured at baseline and one year after 4 weeks of training. Maximum brake compression measures the most that the brake pedal was compressed during driving, with a minimum of 0 and a maximum of 1. Maximum brake compression may indicate urgent stopping.
Driving Simulator Hazard Perception at One Year	Baseline, One-year after 4-week intervention training	Driving simulator (scenarios including hazards) measures of speed, maximum brake compression, and lane position, at baseline and one year after 4 weeks of training. These measures provide an estimate of accuracy in driving scenarios that involve hazards in the DriveSafety simulator (using 3 parallel forms). All measures were transformed into Z scores and averaged in order to create a measure of overall driving performance, where higher scores represent more dangerous (worse) driving performance.
Speed of Processing at One Year	Baseline, One-year after 4-week intervention training	Scores from Useful Field of View (UFOV) test and Digit Symbol Substitution Test, at baseline and one year after 4 weeks of training, which each provide a measure of speed of processing. Raw scores were transformed into z scores, UFOV reaction time scores were inverted, then UFOV and digit symbol scores were averaged in order to create an estimate of overall speed of processing, where higher scores represent better performance.
Knowledge About Driving at One Year	One-year after 4-week intervention training	Test questions based on the American Association of Retired Persons driving course, measured one year after 4 weeks of training, with a minimum score of 0 and a maximum score of 3. Higher scores indicate more accurate knowledge of driving related information.
Driving Simulator Average Speed Post Training	Baseline, Immediately after 4-week intervention training	Average speed in a driving simulator measured at baseline and immediately after 4 weeks of training. Speed is a continuous measure in miles per hour, with a minimum of 0 and no maximum. Speed may indicate risky driving behavior.
Driving Simulator Max Brake Compression Post Training	Baseline, Immediately after 4-week intervention training	Maximum brake compression in a driving simulator measured at baseline and immediately after 4 weeks of training. Maximum brake compression measures the most that the brake pedal was compressed during driving, with a minimum of 0 and a maximum of 1. Maximum brake compression may indicate urgent stopping.
Driving Simulator Average Lane Position at One Year	Baseline, One-year after 4-week intervention training	Average lane position in a driving simulator measured at baseline and one year after 4 weeks of training. Lane position measures the average deviation from the center of a lane while driving (values from -1 to 1), averaged across participants, where 0 represents perfect center, negative scores represent deviation to the left (from 0 to -1), and positive scores represent deviation to the right (from 0 to 1). Lane position indicates vehicle control and safety.
Useful Field of View Post Training	Baseline, Immediately after 4-week intervention training	Useful field of view (UFOV) measured at baseline and immediately after 4 weeks of training. UFOV is measured as a response time in milliseconds, with lower times indicating quicker responses.
Digit Symbol Substitution Test Post Training	Baseline, Immediately after 4-week intervention training	The Digit Symbol Substitution Test measured at baseline and immediately after 4 weeks of training. The Digit Symbol Substitution Test is measured through the number of items completed during a 90 second period, where higher scores indicate faster/better performance.
Useful Field of View at One Year	Baseline, One-year after 4-week intervention training	Useful field of view (UFOV) measured at baseline and one year after 4 weeks of training. UFOV is measured as a response time in milliseconds, with lower times indicating quicker responses.
Knowledge About Finances and Fraud Post Training	Immediately after 4-week intervention training	Test questions based on the Finance and Fraud training tutorial, measured immediately after 4 weeks of training, with a minimum score of 0 and a maximum score of 3. Higher scores indicate more accurate knowledge of finance and fraud related information.
Digit Symbol Substitution Test at One Year	Baseline, One-year after 4-week intervention training	The Digit Symbol Substitution Test measured at baseline and one year after 4 weeks of training. The Digit Symbol Substitution Test is measured through the number of items completed during a 90 second period, where higher scores indicate faster/better performance.
Driving Simulator Hazard Perception Post Training	Baseline, Immediately after 4-week intervention training	Driving simulator (scenarios including hazards) measures of speed, maximum brake compression, and lane position, at baseline and immediately after 4 weeks of training. These measures provide an estimate of accuracy in driving scenarios that involve hazards in the DriveSafety simulator (using 3 parallel forms). All measures were transformed into Z scores and averaged in order to create a measure of overall driving performance, where higher scores represent more dangerous (worse) driving performance.
Speed of Processing Post Training	Baseline, Immediately after 4-week intervention training	Scores from Useful Field of View (UFOV) test and Digit Symbol Substitution Test, at baseline and immediately after 4 weeks of training, which each provide a measure of speed of processing. Raw scores were transformed into z scores, UFOV reaction time scores were inverted, then both UFOV and digit symbol scores were averaged in order to create an estimate of overall speed of processing, where higher scores represent better performance.
Knowledge About Driving Post Training	Immediately after 4-week intervention training	Test questions based on the American Association of Retired Persons driving course, measured immediately after 4 weeks of training, with a minimum score of 0 and a maximum score of 3. Higher scores indicate more accurate knowledge of driving related information.
Fraud Detection Post Training	Baseline, Immediately after 4-week intervention training	Percent confidence that a given vignette describing fraud is actually an example of fraud, measured at baseline and immediately after 4 weeks of training. Participants were given a vignette describing fraud (which was mixed in with vignettes not describing fraud) and were asked to give their percent confidence that this is actually an example of fraud. Higher confidence indicates higher accuracy when detecting fraud, with a minimum of 0 and a maximum of 100. Measures accuracy in discriminating fraud from non-fraud text-based scenarios (using 3 parallel forms).
Self-reported Difficulty With Instrumental Activities of Daily Living (IADLs) Post Training	Baseline, Immediately after 4-week intervention training	Self-reported difficulties in completing instrumental activities of daily living, measured at baseline and immediately after 4 weeks of training, with a minimum score of 0 (indicating no difficulty) and a maximum of 3 (indicating severe difficulty). This is a modified short-form version of the Lawton IADL Items, used in the Multicenter AIDS Cohort Study (MACS).
Fraud Detection at One Year	Baseline, One-year after 4-week intervention training	Percent confidence that a given vignette describing fraud is actually an example of fraud, measured at baseline and one year after 4 weeks of training. Participants were given a vignette describing fraud (which was mixed in with vignettes not describing fraud) and were asked to give their percent confidence that this is actually an example of fraud. Higher confidence indicates higher accuracy when detecting fraud, with a minimum of 0 and a maximum of 100. Measures accuracy in discriminating fraud from non-fraud text-based scenarios (using 3 parallel forms).
Self-reported Difficulty With Instrumental Activities of Daily Living (IADLs) at One Year	Baseline, One-year after 4-week intervention training	Self-reported difficulties in completing instrumental activities of daily living, measured at baseline and one year after 4 weeks of training, with a minimum score of 0 (indicating no difficulty) and a maximum of 3 (indicating severe difficulty).This is a modified short-form version of the Lawton IADL Items, used in the Multicenter AIDS Cohort Study (MACS).
Knowledge About Finances and Fraud at One Year	One-year after 4-week intervention training	Test questions based on the Finance and Fraud training tutorial, measured immediately after one year of training, with a minimum score of 0 and a maximum score of 3. Higher scores indicate more accurate knowledge of finance and fraud related information.

Secondary Outcome Measures

Name	Time	Method
Numeracy at One Year	Baseline, One-year after 4-week intervention training	Score on the Berlin Numeracy Test taken at baseline and one year after 4 weeks of training. Scores represent the number of correct items, where higher scores represent better performance, with a minimum score of 0 and a maximum score of 3.
Technology Proficiency Post Training	Baseline, Immediately after 4-week intervention training	Standardized Z-scores of Computer Proficiency Questionnaire and the Mobile Device Proficiency Questionnaire, at baseline and immediately after 4 weeks of training, which provide measures of technology proficiency. Scores are measured as a self-assessed proficiency, where higher scores indicate a higher proficiency and greater ease using a device on various tasks. Scores are standardized using z-scores, with the average at the baseline representing 0, and 1 representing one standard deviation above the average baseline score.
Numeracy Post Training	Baseline, Immediately after 4-week intervention training	Score on the Berlin Numeracy Test taken at baseline and immediately after 4 weeks of training. Scores represent the number of correct items, where higher scores represent better performance, with a minimum score of 0 and a maximum score of 3.
Technology Proficiency at One Year	Baseline, One-year after 4-week intervention training	Standardized Z-scores of Computer Proficiency Questionnaire and the Mobile Device Proficiency Questionnaire, at baseline and one year after 4 weeks of training, which provide measures of technology proficiency. Scores are measured as a self-assessed proficiency, where higher scores indicate a higher proficiency and greater ease using a device on various tasks. Scores are standardized using z-scores, with the average at the baseline representing 0, and 1 representing one standard deviation above the average baseline score.
Reasoning Ability Post Training	Baseline, Immediately after 4-week intervention training	Standardized Z-scores from Raven's Advanced Progressive Matrices and Letter Sets tests, at baseline and immediately after 4 weeks of training, which provide measures of reasoning ability. Scores represent the number of correct items, where higher scores represent better performance. Scores are standardized using z-scores, with the average at the baseline representing 0, and 1 representing one standard deviation above the average baseline score.
Miami Instrumental Activities of Daily Living Task Post Training	Baseline, Immediately after 4-week intervention training	Score on Miami Instrumental Activities of Daily Living task, at baseline and immediately after 4 weeks of training, based on number of correct tasks/time completed. Higher scores represent more tasks completed per minute, and therefore better performance. Scores have a minimum of 0, and no set maximum.
Miami Instrumental Activities of Daily Living Task at One Year	Baseline, One-year after 4-week intervention training	Score on Miami Instrumental Activities of Daily Living task, at baseline and one year after 4 weeks of training, based on number of correct tasks/time completed. Higher scores represent more tasks completed per minute, and therefore better performance. Scores have a minimum of 0, and no set maximum.
Memory Ability at One Year	Baseline, One-year after 4-week intervention training	Standardized Z-scores from Hopkins Verbal Learning and Rey Auditory Verbal Learning Tests, at baseline and one year after 4 weeks of training, which provide measures of memory ability. Scores represent the number of correctly recalled items, where higher scores represent better memory. Scores are standardized using z-scores, with the average at the baseline representing 0, and 1 representing one standard deviation above the average baseline score.
Reasoning Ability at One Year	Baseline, One-year after 4-week intervention training	Standardized Z-scores from Raven's Advanced Progressive Matrices and Letter Sets tests, at baseline and one year after 4 weeks of training, which provide measures of reasoning ability. Scores represent the number of correct items, where higher scores represent better performance. Scores are standardized using z-scores, with the average at the baseline representing 0, and 1 representing one standard deviation above the average baseline score.
Memory Ability Post Training	Baseline, Immediately after 4-week intervention training	Standardized Z-scores from Hopkins Verbal Learning and Rey Auditory Verbal Learning Tests, at baseline and immediately after 4 weeks of training, which provide measures of memory ability. Scores represent the number of correctly recalled items, where higher scores represent better memory. Scores are standardized using z-scores, with the average at the baseline representing 0, and 1 representing one standard deviation above the average baseline score.