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Cognitive AgingICE-ACTNCT03141281

Intervention Comparative Effectiveness for Adult Cognitive Training

A study testing BrainHQ, Rise of Nations and IADL Training in people with Cognitive Aging, run by Florida State University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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 more about this study

Who is it for?
Ages 65 years and olderHealthy volunteers can take part
Conditions the study is for
Cognitive Aging
What is being tested?
BrainHQ, Rise of Nations and IADL Training
Could I receive a placebo?
No, everyone receives an active treatment
How many people
238 participants
Where
1 siteUnited States
Study dates
20 Sep 2017to 3 Sep 2019
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
Show all 9Show fewer
  • Has played the Rise of Nations video game
  • Has trained with Posit Science's "BrainHQ"
  • Has trained on the Mind Frontiers video game.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Florida State University

    Tallahassee, Florida, 32306-4301

Other trials in United States

About this study

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.

Conditions
Cognitive Aging
Being tested
BrainHQ, Rise of Nations, IADL Training, Active Control
Keywords
aging, cognitive ability, IADL, driving, financial fraud, perception, attention, memory

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • BrainHQBehavioural

    BrainHQ

  • Rise of NationsBehavioural

    Rise of Nations

  • IADL TrainingBehavioural

    IADL Training

  • Active ControlBehavioural

    Puzzle solving

Study groups in NCT03141281
Study groupRoleWhat they receive
BrainHQExperimentalParticipants 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.
Receives: Behavioral: BrainHQ
Rise of NationsExperimentalParticipants 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
Receives: Behavioral: Rise of Nations
IADL trainingExperimentalParticipants 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.
Receives: Behavioral: IADL Training
Active ControlActive comparatorParticipants will be provided with a laptop computer and asked to complete 20 hr of training with Sudoku, crossword puzzles, and word search
Receives: Behavioral: Active Control

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: 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.

    Measured: 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).

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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).

    Measured: 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.

    Measured: 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).

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: Baseline, One-year after 4-week intervention training

Secondary outcomes (10)
  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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: 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.

    Measured: Baseline, One-year after 4-week intervention training

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 May 2017
  2. Study start20 Sep 2017
  3. Primary completion3 Sep 2019
  4. Study completion3 Sep 2019

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Model description
Random assignment to one of four treatment groups at study entry
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
238 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03141281
Sponsor's protocol ID
2017.20622
Other IDs
2017
Acronym
ICE-ACT
Status last verified
May 2021
First submitted
1 May 2017
Last updated
7 Jun 2021
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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

Questions about this trial

What is this clinical trial studying?

A study testing BrainHQ, Rise of Nations and IADL Training in people with Cognitive Aging, run by Florida State University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Jun 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fraud Detection Post Training (time frame: Baseline, Immediately after 4-week intervention training). The study lists 22 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03141281, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2021.

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