CClinicalTrials.gg
CompletedNCT03141281ICE-ACTUpdated Jun 7, 2021Results posted

Intervention Comparative Effectiveness for Adult Cognitive Training

An interventional study of BrainHQ and Rise of Nations in Cognitive Aging, sponsored by Florida State University. Completed at 1 site in United States. Open to participants aged 65 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-06-07.

Sponsored by Florida State University · Not applicable, Interventional, and Basic science

Phase
Not applicable
Study type
Interventional
Enrollment
238
Allocation
Randomized
Ages
65 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Cognitive Aging

Keywords

  • aging
  • cognitive ability
  • IADL
  • driving
  • financial fraud
  • perception
  • attention
  • memory
03

In context

Lead sponsor

Florida State University is the lead sponsor of 241 studies on the registry; 46 are open to participants now.

Of its 15 completed or terminated interventional studies of FDA-regulated products, 9 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
65 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Basic science
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
238 participants (actual)

Study arms

  • Experimental
    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.

    Behavioral: BrainHQ

  • Experimental
    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

    Behavioral: Rise of Nations

  • Experimental
    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.

    Behavioral: IADL Training

  • Active comparator
    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

    Behavioral: Active Control

Interventions

  • BehavioralBrainHQ

    BrainHQ

  • BehavioralRise of Nations

    Rise of Nations

  • BehavioralIADL Training

    IADL Training

  • BehavioralActive Control

    Puzzle solving

06

What researchers measure

Primary outcomes

  1. Fraud Detection Post 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).

    Time frame: Baseline, Immediately after 4-week intervention training

  2. Driving Simulator Hazard Perception Post 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.

    Time frame: Baseline, Immediately after 4-week intervention training

  3. Self-reported Difficulty With Instrumental Activities of Daily Living (IADLs) Post 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).

    Time frame: Baseline, Immediately after 4-week intervention training

  4. Speed of Processing Post 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.

    Time frame: Baseline, Immediately after 4-week intervention training

  5. Knowledge About Driving Post 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.

    Time frame: Immediately after 4-week intervention training

  6. Knowledge About Finances and Fraud Post 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.

    Time frame: Immediately after 4-week intervention training

  7. Fraud Detection at One Year

    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).

    Time frame: Baseline, One-year after 4-week intervention training

  8. Driving Simulator Hazard Perception at One Year

    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.

    Time frame: Baseline, One-year after 4-week intervention training

  9. Self-reported Difficulty With Instrumental Activities of Daily Living (IADLs) at One Year

    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).

    Time frame: Baseline, One-year after 4-week intervention training

  10. Speed of Processing at One Year

    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.

    Time frame: Baseline, One-year after 4-week intervention training

  11. Knowledge About Driving at One Year

    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.

    Time frame: One-year after 4-week intervention training

  12. Knowledge About Finances and Fraud at One Year

    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.

    Time frame: One-year after 4-week intervention training

  13. Driving Simulator Average Speed Post 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.

    Time frame: Baseline, Immediately after 4-week intervention training

  14. Driving Simulator Max Brake Compression Post 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.

    Time frame: Baseline, Immediately after 4-week intervention training

  15. Driving Simulator Average Lane Position Post 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.

    Time frame: Baseline, Immediately after 4-week intervention training

  16. Driving Simulator Average Speed at One Year

    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.

    Time frame: Baseline, One-year after 4-week intervention training

  17. Driving Simulator Max Brake Compression at One Year

    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.

    Time frame: Baseline, One-year after 4-week intervention training

  18. Driving Simulator Average Lane Position at One Year

    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.

    Time frame: Baseline, One-year after 4-week intervention training

  19. Useful Field of View Post 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.

    Time frame: Baseline, Immediately after 4-week intervention training

  20. Digit Symbol Substitution Test Post 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.

    Time frame: Baseline, Immediately after 4-week intervention training

  21. Useful Field of View at One Year

    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.

    Time frame: Baseline, One-year after 4-week intervention training

  22. Digit Symbol Substitution Test at One Year

    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.

    Time frame: Baseline, One-year after 4-week intervention training

Secondary outcomes

  1. Technology Proficiency Post 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.

    Time frame: Baseline, Immediately after 4-week intervention training

  2. Technology Proficiency at One Year

    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.

    Time frame: Baseline, One-year after 4-week intervention training

  3. Numeracy Post 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.

    Time frame: Baseline, Immediately after 4-week intervention training

  4. Numeracy at One Year

    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.

    Time frame: Baseline, One-year after 4-week intervention training

  5. Reasoning Ability Post 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.

    Time frame: Baseline, Immediately after 4-week intervention training

  6. Reasoning Ability at One Year

    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.

    Time frame: Baseline, One-year after 4-week intervention training

  7. Memory Ability Post 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.

    Time frame: Baseline, Immediately after 4-week intervention training

  8. Memory Ability at One Year

    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.

    Time frame: Baseline, One-year after 4-week intervention training

  9. Miami Instrumental Activities of Daily Living Task Post 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.

    Time frame: Baseline, Immediately after 4-week intervention training

  10. Miami Instrumental Activities of Daily Living Task at One Year

    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.

    Time frame: Baseline, One-year after 4-week intervention training

07

Results

Posted Jun 7, 2021

Participant flow

Participant flow — Overall Study
MilestoneBrainHQRise of NationsIADL TrainingActive Control
Started57595658
Post-test50475056
Completed45384247
Not completed12211411

Outcome measures

PrimaryFraud Detection Post 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).

Time frame:
Baseline, Immediately after 4-week intervention training
Reported as:
Mean · % confidence fraudulent item is fraud
Fraud Detection Post Training
% confidence fraudulent item is fraudBrainHQRise of NationsIADL TrainingActive Control
Baseline90.42 ± 9.0385.84 ± 18.3384.88 ± 12.3184.32 ± 16.95
Post Training85.91 ± 13.7686.34 ± 10.9185.88 ± 19.3783.84 ± 14.86
PrimaryDriving Simulator Hazard Perception Post 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.

Time frame:
Baseline, Immediately after 4-week intervention training
Reported as:
Mean · z-score
Driving Simulator Hazard Perception Post Training
z-scoreBrainHQRise of NationsIADL TrainingActive Control
Composite Driving Baseline-0.06 ± 0.410.26 ± 0.320.02 ± 0.320.12 ± 0.38
Composite Driving Post Training0.09 ± 0.43-0.10 ± 1.20-0.21 ± 1.130.11 ± 0.62
PrimarySelf-reported Difficulty With Instrumental Activities of Daily Living (IADLs) Post 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).

Time frame:
Baseline, Immediately after 4-week intervention training
Reported as:
Mean · units on a scale
Self-reported Difficulty With Instrumental Activities of Daily Living (IADLs) Post Training
units on a scaleBrainHQRise of NationsIADL TrainingActive Control
Baseline0.31 ± 0.870.26 ± 0.940.38 ± 1.520.39 ± 0.95
Post Training0.35 ± 1.030.23 ± 0.890.22 ± 1.420.21 ± 0.73
PrimarySpeed of Processing Post 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.

Time frame:
Baseline, Immediately after 4-week intervention training
Reported as:
Mean · z-score
Speed of Processing Post Training
z-scoreBrainHQRise of NationsIADL TrainingActive Control
Speed of Processing Baseline0.09 ± 0.870.03 ± 0.81-0.03 ± 0.650.01 ± 0.79
Speed of Processing Post Training0.34 ± 0.850.16 ± 0.800.15 ± 0.710.13 ± 0.87
PrimaryKnowledge About Driving Post 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.

Time frame:
Immediately after 4-week intervention training
Reported as:
Mean · score on a scale
Knowledge About Driving Post Training
score on a scaleBrainHQRise of NationsIADL TrainingActive Control
Knowledge About Driving Post Training1.49 ± 0.741.53 ± 0.752.28 ± 0.901.36 ± 0.77
PrimaryKnowledge About Finances and Fraud Post 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.

Time frame:
Immediately after 4-week intervention training
Reported as:
Mean · score on a scale
Knowledge About Finances and Fraud Post Training
score on a scaleBrainHQRise of NationsIADL TrainingActive Control
Knowledge About Finances and Fraud Post Training1.65 ± 1.011.62 ± 1.012.24 ± 0.771.54 ± 0.95
PrimaryFraud Detection at One Year

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).

Time frame:
Baseline, One-year after 4-week intervention training
Reported as:
Mean · % confidence fraudulent item is fraud
Fraud Detection at One Year
% confidence fraudulent item is fraudBrainHQRise of NationsIADL TrainingActive Control
Baseline90.88 ± 8.8687.78 ± 16.3886.30 ± 11.1784.86 ± 17.58
Follow-up87.79 ± 8.9587.17 ± 12.8791.84 ± 7.6285.55 ± 11.56
PrimaryDriving Simulator Hazard Perception at One Year

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.

Time frame:
Baseline, One-year after 4-week intervention training
Reported as:
Mean · z-score
Driving Simulator Hazard Perception at One Year
z-scoreBrainHQRise of NationsIADL TrainingActive Control
Composite Driving Baseline0.02 ± 0.440.31 ± 0.25-0.06 ± 0.280.07 ± 0.38
Composite Driving Follow-up0.11 ± 0.500.34 ± 0.320.19 ± 0.330.18 ± 0.37
PrimarySelf-reported Difficulty With Instrumental Activities of Daily Living (IADLs) at One Year

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).

Time frame:
Baseline, One-year after 4-week intervention training
Reported as:
Mean · units on a scale
Self-reported Difficulty With Instrumental Activities of Daily Living (IADLs) at One Year
units on a scaleBrainHQRise of NationsIADL TrainingActive Control
Baseline0.27 ± 0.810.16 ± 0.440.10 ± 0.440.36 ± 0.92
Follow-up0.38 ± 1.540.22 ± 0.630.10 ± 0.370.34 ± 1.31
PrimarySpeed of Processing at One Year

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.

Time frame:
Baseline, One-year after 4-week intervention training
Reported as:
Mean · z-score
Speed of Processing at One Year
z-scoreBrainHQRise of NationsIADL TrainingActive Control
Speed of Processing Baseline0.10 ± 0.890.12 ± 0.820.07 ± 0.470.01 ± 0.81
Speed of Processing Follow-up0.22 ± 0.890.36 ± 0.570.15 ± 0.670.19 ± 0.74
PrimaryKnowledge About Driving at One Year

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.

Time frame:
One-year after 4-week intervention training
Reported as:
Mean · score on a scale
Knowledge About Driving at One Year
score on a scaleBrainHQRise of NationsIADL TrainingActive Control
Knowledge About Driving at One Year1.36 ± 0.831.46 ± 0.771.59 ± 0.841.62 ± 0.74
PrimaryKnowledge About Finances and Fraud at One Year

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.

Time frame:
One-year after 4-week intervention training
Reported as:
Mean · score on a scale
Knowledge About Finances and Fraud at One Year
score on a scaleBrainHQRise of NationsIADL TrainingActive Control
Knowledge About Finances and Fraud at One Year1.53 ± 0.891.95 ± 0.881.78 ± 0.881.55 ± 0.95
PrimaryDriving Simulator Average Speed Post 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.

Time frame:
Baseline, Immediately after 4-week intervention training
Reported as:
Mean · Miles Per Hour
Driving Simulator Average Speed Post Training
Miles Per HourBrainHQRise of NationsIADL TrainingActive Control
Speed Baseline12.46 ± 1.8713.46 ± 1.3812.71 ± 1.6313.12 ± 1.47
Speed Post Training13.25 ± 1.7512.88 ± 4.0111.88 ± 3.9013.21 ± 2.46
PrimaryDriving Simulator Max Brake Compression Post 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.

Time frame:
Baseline, Immediately after 4-week intervention training
Reported as:
Mean · units on a scale
Driving Simulator Max Brake Compression Post Training
units on a scaleBrainHQRise of NationsIADL TrainingActive Control
Max Brake Baseline0.98 ± 0.051.00 ± 0.000.99 ± 0.051.00 ± 0.00
Max Brake Post Training0.99 ± 0.040.91 ± 0.280.90 ± 0.270.97 ± 0.17
PrimaryDriving Simulator Average Lane Position Post 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.

Time frame:
Baseline, Immediately after 4-week intervention training
Reported as:
Mean · units on a scale
Driving Simulator Average Lane Position Post Training
units on a scaleBrainHQRise of NationsIADL TrainingActive Control
Lane Position Baseline-0.43 ± 0.13-0.35 ± 0.11-0.41 ± 0.12-0.40 ± 0.13
Lane Position Post Training-0.41 ± 0.16-0.39 ± 0.13-0.39 ± 0.17-0.37 ± 0.12
PrimaryDriving Simulator Average Speed at One Year

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.

Time frame:
Baseline, One-year after 4-week intervention training
Reported as:
Mean · Miles Per Hour
Driving Simulator Average Speed at One Year
Miles Per HourBrainHQRise of NationsIADL TrainingActive Control
Speed Baseline12.71 ± 1.8913.76 ± 1.0813.04 ± 1.6512.96 ± 1.40
Speed Follow-up13.36 ± 1.5414.08 ± 0.9713.28 ± 1.1513.70 ± 1.46
PrimaryDriving Simulator Max Brake Compression at One Year

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.

Time frame:
Baseline, One-year after 4-week intervention training
Reported as:
Mean · units on a scale
Driving Simulator Max Brake Compression at One Year
units on a scaleBrainHQRise of NationsIADL TrainingActive Control
Max Brake Baseline0.99 ± 0.041.00 ± 0.000.99 ± 0.061.00 ± 0.00
Max Brake Follow-up0.98 ± 0.061.00 ± 0.001.00 ± 0.000.99 ± 0.04
PrimaryDriving Simulator Average Lane Position at One Year

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.

Time frame:
Baseline, One-year after 4-week intervention training
Reported as:
Mean · units on a scale
Driving Simulator Average Lane Position at One Year
units on a scaleBrainHQRise of NationsIADL TrainingActive Control
Lane Position Baseline-0.41 ± 0.14-0.35 ± 0.11-0.46 ± 0.09-0.41 ± 0.13
Lane Position Follow-up-0.40 ± 0.19-0.35 ± 0.14-0.37 ± 0.14-0.39 ± 0.11
PrimaryUseful Field of View Post 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.

Time frame:
Baseline, Immediately after 4-week intervention training
Reported as:
Mean · Milliseconds
Useful Field of View Post Training
MillisecondsBrainHQRise of NationsIADL TrainingActive Control
UFOV Baseline225.84 ± 201.81229.08 ± 242.48228.55 ± 134.75212.14 ± 145.31
UFOV Post Training170.04 ± 194.38217.47 ± 192.39210.87 ± 154.27219.92 ± 215.25
PrimaryDigit Symbol Substitution Test Post 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.

Time frame:
Baseline, Immediately after 4-week intervention training
Reported as:
Mean · items completed
Digit Symbol Substitution Test Post Training
items completedBrainHQRise of NationsIADL TrainingActive Control
Digit Symbol Baseline46.45 ± 12.4945.36 ± 10.7744.04 ± 10.1143.71 ± 13.22
Digit Symbol Post Training48.90 ± 11.8748.66 ± 10.4346.80 ± 12.2447.07 ± 12.79
PrimaryUseful Field of View at One Year

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.

Time frame:
Baseline, One-year after 4-week intervention training
Reported as:
Mean · Milliseconds
Useful Field of View at One Year
MillisecondsBrainHQRise of NationsIADL TrainingActive Control
UFOV Baseline229.38 ± 205.25199.58 ± 229.19206.54 ± 113.42211.90 ± 154.92
UFOV Follow-up200.85 ± 215.83158.65 ± 68.70214.71 ± 152.89192.18 ± 148.15
PrimaryDigit Symbol Substitution Test at One Year

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.

Time frame:
Baseline, One-year after 4-week intervention training
Reported as:
Mean · items completed
Digit Symbol Substitution Test at One Year
items completedBrainHQRise of NationsIADL TrainingActive Control
Digit Symbol Baseline47.02 ± 12.7645.65 ± 10.7944.84 ± 7.8443.58 ± 12.74
Digit Symbol Follow-up48.36 ± 13.2247.65 ± 14.9748.05 ± 9.7746.90 ± 12.25
SecondaryTechnology Proficiency Post 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.

Time frame:
Baseline, Immediately after 4-week intervention training
Reported as:
Mean · z-score
Technology Proficiency Post Training
z-scoreBrainHQRise of NationsIADL TrainingActive Control
CPQ Baseline0.16 ± 0.950.21 ± 0.83-0.03 ± 1.03-0.13 ± 1.14
CPQ Post Training0.24 ± 0.900.16 ± 0.950.08 ± 1.01-0.06 ± 1.20
MDPQ Baseline0.11 ± 1.020.21 ± 0.90-0.07 ± 1.030.05 ± 1.03
MDPQ Post Training0.23 ± 1.000.09 ± 0.93-0.04 ± 1.070.07 ± 1.04
SecondaryTechnology Proficiency at One Year

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.

Time frame:
Baseline, One-year after 4-week intervention training
Reported as:
Mean · z-score
Technology Proficiency at One Year
z-scoreBrainHQRise of NationsIADL TrainingActive Control
CPQ Baseline0.11 ± 0.970.35 ± 0.660.06 ± 0.91-0.21 ± 1.20
CPQ Follow-up0.20 ± 0.890.50 ± 0.700.29 ± 0.820.11 ± 1.13
MDPQ Baseline0.03 ± 1.020.40 ± 0.72-0.04 ± 0.95-0.01 ± 1.05
MDPQ Follow-up0.15 ± 1.020.39 ± 0.860.20 ± 1.020.20 ± 1.07
SecondaryNumeracy Post 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.

Time frame:
Baseline, Immediately after 4-week intervention training
Reported as:
Mean · score on a scale
Numeracy Post Training
score on a scaleBrainHQRise of NationsIADL TrainingActive Control
Baseline2.41 ± 1.552.49 ± 1.322.38 ± 1.502.39 ± 1.57
Follow-up2.45 ± 1.472.66 ± 1.702.16 ± 1.652.48 ± 1.78
SecondaryNumeracy at One Year

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.

Time frame:
Baseline, One-year after 4-week intervention training
Reported as:
Mean · score on a scale
Numeracy at One Year
score on a scaleBrainHQRise of NationsIADL TrainingActive Control
Baseline2.36 ± 1.482.65 ± 1.272.47 ± 1.522.52 ± 1.60
Follow-up2.40 ± 1.452.76 ± 1.402.14 ± 1.812.52 ± 1.69
SecondaryReasoning Ability Post 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.

Time frame:
Baseline, Immediately after 4-week intervention training
Reported as:
Mean · z-score
Reasoning Ability Post Training
z-scoreBrainHQRise of NationsIADL TrainingActive Control
Raven's Baseline0.10 ± 0.980.14 ± 0.94-0.18 ± 0.87-0.02 ± 1.08
Raven's Post Training0.08 ± 1.030.13 ± 0.97-0.01 ± 1.03-0.07 ± 1.19
Letter Sets Baseline0.19 ± 0.88-0.07 ± 0.990.01 ± 1.010.00 ± 1.06
Letter Sets Post Training0.24 ± 0.960.40 ± 0.840.23 ± 0.970.21 ± 1.05
SecondaryReasoning Ability at One Year

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.

Time frame:
Baseline, One-year after 4-week intervention training
Reported as:
Mean · z-score
Reasoning Ability at One Year
z-scoreBrainHQRise of NationsIADL TrainingActive Control
Raven's Baseline0.10 ± 0.940.14 ± 0.98-0.10 ± 0.860.05 ± 1.05
Raven's Follow-up-0.04 ± 1.070.08 ± 0.910.01 ± 1.10-0.07 ± 1.09
Letter Sets Baseline0.25 ± 0.85-0.07 ± 0.980.06 ± 0.870.02 ± 1.10
Letter Sets Follow-up0.21 ± 0.990.36 ± 0.940.22 ± 0.900.06 ± 1.14
SecondaryMemory Ability Post 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.

Time frame:
Baseline, Immediately after 4-week intervention training
Reported as:
Mean · z-score
Memory Ability Post Training
z-scoreBrainHQRise of NationsIADL TrainingActive Control
Hopkins Baseline-0.01 ± 0.890.04 ± 0.990.04 ± 1.120.15 ± 0.88
Hopkins Post Training0.23 ± 0.970.05 ± 0.95-0.12 ± 1.220.22 ± 0.93
Rey Baseline-0.22 ± 0.940.04 ± 1.050.03 ± 1.030.17 ± 0.96
Rey Post Training-0.03 ± 1.04-0.03 ± 1.00-0.04 ± 1.100.24 ± 1.07
SecondaryMemory Ability at One Year

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.

Time frame:
Baseline, One-year after 4-week intervention training
Reported as:
Mean · z-score
Memory Ability at One Year
z-scoreBrainHQRise of NationsIADL TrainingActive Control
Hopkins Baseline0.06 ± 0.880.10 ± 0.860.16 ± 0.980.25 ± 0.86
Hopkins Follow-up0.19 ± 1.000.21 ± 0.790.21 ± 1.150.40 ± 0.87
Rey Baseline-0.18 ± 0.960.06 ± 1.010.16 ± 1.020.21 ± 0.97
Rey Follow-up0.23 ± 1.230.22 ± 0.89-0.09 ± 1.000.44 ± 1.14
SecondaryMiami Instrumental Activities of Daily Living Task Post 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.

Time frame:
Baseline, Immediately after 4-week intervention training
Reported as:
Mean · Tasks completed per minute
Miami Instrumental Activities of Daily Living Task Post Training
Tasks completed per minuteBrainHQRise of NationsIADL TrainingActive Control
ATM Task Baseline3.17 ± 1.322.78 ± 1.032.67 ± 1.202.81 ± 1.13
ATM Task Post Training3.19 ± 1.073.23 ± 1.012.98 ± 1.072.97 ± 1.10
Prescription Task Baseline4.31 ± 4.543.67 ± 1.443.54 ± 1.323.40 ± 1.50
Prescription Task Post Training4.75 ± 2.494.91 ± 5.434.20 ± 1.584.14 ± 3.15
SecondaryMiami Instrumental Activities of Daily Living Task at One Year

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.

Time frame:
Baseline, One-year after 4-week intervention training
Reported as:
Mean · Tasks completed per minute
Miami Instrumental Activities of Daily Living Task at One Year
Tasks completed per minuteBrainHQRise of NationsIADL TrainingActive Control
ATM Task Baseline3.18 ± 1.313.03 ± 0.942.78 ± 1.192.79 ± 1.13
ATM Task Follow-up3.09 ± 1.113.26 ± 1.143.12 ± 1.262.85 ± 1.04
Prescription Task Baseline4.40 ± 4.723.72 ± 1.393.65 ± 1.303.40 ± 1.47
Prescription Task Follow-up4.22 ± 2.313.98 ± 1.094.08 ± 2.134.26 ± 2.04

Adverse events

Collected over From enrollment to the end of the follow-up assessment (approx. 1 year). Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
BrainHQ0/57 (0%)0/57 (0%)0/57 (0%)
Rise of Nations0/59 (0%)0/59 (0%)0/59 (0%)
IADL Training0/56 (0%)0/56 (0%)0/56 (0%)
Active Control0/58 (0%)0/58 (0%)0/58 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(years)BrainHQRise of NationsIADL TrainingActive ControlTotal
Mean71.5 ± 5.971.4 ± 5.772.4 ± 5.570.2 ± 3.871.4 ± 5.3
Sex: Female, Male
Sex: Female, Male(Participants)BrainHQRise of NationsIADL TrainingActive ControlTotal
Female33333631133
Male2426202797
Race (NIH/OMB)
Race (NIH/OMB)(Participants)BrainHQRise of NationsIADL TrainingActive ControlTotal
American Indian or Alaska Native10001
Asian10001
Native Hawaiian or Other Pacific Islander00011
Black or African American5471026
White40414044165
More than one race11114
Unknown or Not Reported9138232
Region of Enrollment
Region of Enrollment(participants)BrainHQRise of NationsIADL TrainingActive ControlTotal
United States57595658230
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Study locations

1 site
  • Florida State University
    Tallahassee, Florida 32306-4301, United States
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References and documents

Publications

  • 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. PubMed 34968102 ↗
  • 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. PubMed 30711665 ↗

Study documents

  • Study protocol · Nov 20, 2020
  • Statistical analysis plan · Jul 3, 2017
  • Informed consent form · Apr 23, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 7, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03141281
Lead sponsor
Florida State University
Responsible party
Neil Charness (Principal Investigator, Professor of Psychology, Florida State University) — Principal investigator
First posted
May 5, 2017
Start date
Sep 20, 2017
Primary completion
Sep 3, 2019
Completion
Sep 3, 2019
Results posted
Jun 7, 2021
Last update
Jun 7, 2021

Study contacts

Neil Charness, PhD
principal investigator · Florida State University
Walter Boot, PhD
principal investigator · Florida State University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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