- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03141281
Intervention Comparative Effectiveness for Adult Cognitive Training (ICE-ACT)
May 11, 2021 updated by: Neil Charness, Florida State University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
238
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Florida
-
Tallahassee, Florida, United States, 32306-4301
- Florida State University
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
65 years and older (OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: BASIC_SCIENCE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
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BrainHQ
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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
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Rise of Nations
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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.
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IADL Training
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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
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Puzzle solving
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Fraud Detection Post Training
Time Frame: Baseline, Immediately after 4-week intervention training
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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).
|
Baseline, Immediately after 4-week intervention training
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Driving Simulator Hazard Perception Post Training
Time Frame: 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.
|
Baseline, Immediately after 4-week intervention training
|
Self-reported Difficulty With Instrumental Activities of Daily Living (IADLs) Post Training
Time Frame: 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).
|
Baseline, Immediately after 4-week intervention training
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Speed of Processing Post Training
Time Frame: 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.
|
Baseline, Immediately after 4-week intervention training
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Knowledge About Driving Post Training
Time Frame: 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.
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Immediately after 4-week intervention training
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Knowledge About Finances and Fraud Post Training
Time Frame: 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.
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Immediately after 4-week intervention training
|
Fraud Detection at One Year
Time Frame: 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).
|
Baseline, One-year after 4-week intervention training
|
Driving Simulator Hazard Perception at One Year
Time Frame: 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.
|
Baseline, One-year after 4-week intervention training
|
Self-reported Difficulty With Instrumental Activities of Daily Living (IADLs) at One Year
Time Frame: 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).
|
Baseline, One-year after 4-week intervention training
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Speed of Processing at One Year
Time Frame: 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.
|
Baseline, One-year after 4-week intervention training
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Knowledge About Driving at One Year
Time Frame: One-year after 4-week intervention training
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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.
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One-year after 4-week intervention training
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Knowledge About Finances and Fraud at One Year
Time Frame: One-year after 4-week intervention training
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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.
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One-year after 4-week intervention training
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Driving Simulator Average Speed Post Training
Time Frame: Baseline, Immediately after 4-week intervention training
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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.
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Baseline, Immediately after 4-week intervention training
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Driving Simulator Max Brake Compression Post Training
Time Frame: Baseline, Immediately after 4-week intervention training
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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.
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Baseline, Immediately after 4-week intervention training
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Driving Simulator Average Lane Position Post Training
Time Frame: Baseline, Immediately after 4-week intervention training
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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.
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Baseline, Immediately after 4-week intervention training
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Driving Simulator Average Speed at One Year
Time Frame: 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.
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Baseline, One-year after 4-week intervention training
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Driving Simulator Max Brake Compression at One Year
Time Frame: Baseline, One-year after 4-week intervention training
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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.
|
Baseline, One-year after 4-week intervention training
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Driving Simulator Average Lane Position at One Year
Time Frame: Baseline, One-year after 4-week intervention training
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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.
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Baseline, One-year after 4-week intervention training
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Useful Field of View Post Training
Time Frame: Baseline, Immediately after 4-week intervention training
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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.
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Baseline, Immediately after 4-week intervention training
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Digit Symbol Substitution Test Post Training
Time Frame: Baseline, Immediately after 4-week intervention training
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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.
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Baseline, Immediately after 4-week intervention training
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Useful Field of View at One Year
Time Frame: Baseline, One-year after 4-week intervention training
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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.
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Baseline, One-year after 4-week intervention training
|
Digit Symbol Substitution Test at One Year
Time Frame: Baseline, One-year after 4-week intervention training
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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.
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Baseline, One-year after 4-week intervention training
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Technology Proficiency Post Training
Time Frame: 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.
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Baseline, Immediately after 4-week intervention training
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Technology Proficiency at One Year
Time Frame: 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.
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Baseline, One-year after 4-week intervention training
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Numeracy Post Training
Time Frame: Baseline, Immediately after 4-week intervention training
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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.
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Baseline, Immediately after 4-week intervention training
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Numeracy at One Year
Time Frame: 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.
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Baseline, One-year after 4-week intervention training
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Reasoning Ability Post Training
Time Frame: 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.
|
Baseline, Immediately after 4-week intervention training
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Reasoning Ability at One Year
Time Frame: 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.
|
Baseline, One-year after 4-week intervention training
|
Memory Ability Post Training
Time Frame: 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.
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Baseline, Immediately after 4-week intervention training
|
Memory Ability at One Year
Time Frame: 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.
|
Baseline, One-year after 4-week intervention training
|
Miami Instrumental Activities of Daily Living Task Post Training
Time Frame: 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.
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Baseline, Immediately after 4-week intervention training
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Miami Instrumental Activities of Daily Living Task at One Year
Time Frame: 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.
|
Baseline, One-year after 4-week intervention training
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Neil Charness, PhD, Florida State University
- Principal Investigator: Walter Boot, PhD, Florida State University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
September 20, 2017
Primary Completion (ACTUAL)
September 3, 2019
Study Completion (ACTUAL)
September 3, 2019
Study Registration Dates
First Submitted
May 1, 2017
First Submitted That Met QC Criteria
May 2, 2017
First Posted (ACTUAL)
May 5, 2017
Study Record Updates
Last Update Posted (ACTUAL)
June 7, 2021
Last Update Submitted That Met QC Criteria
May 11, 2021
Last Verified
May 1, 2021
More Information
Terms related to this study
Other Study ID Numbers
- 2017.20622
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Study Data/Documents
-
Statistical Analysis Plan
Information identifier: https://osf.io/dp8n5/Information comments: Open Science Foundation registration of Data Analysis Plan
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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