Intervention Comparative Effectiveness for Adult Cognitive Training

Cognitive Aging Clinical Trial

— ICE-ACT  

Official title:

Intervention Comparative Effectiveness for Adult Cognitive Training

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03141281
• Other study ID #: 2017.20622
• Status: Completed
• Phase: N/A
• Start date: September 20, 2017
• Est. completion date: September 3, 2019

Study information

• Verified date: May 2021
• Source: Florida State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 238
• Est. completion date: September 3, 2019
• Est. primary completion date: September 3, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 65 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Cognitive Aging

Intervention

Behavioral:
• BrainHQ
BrainHQ
• Rise of Nations
Rise of Nations
• IADL Training
IADL Training
• Active Control
Puzzle solving

Locations

Country	Name	City	State
United States	Florida State University	Tallahassee	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Florida State University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	Baseline, Immediately after 4-week intervention training
Primary	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.	Baseline, Immediately after 4-week intervention training
Primary	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).	Baseline, Immediately after 4-week intervention training
Primary	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.	Baseline, Immediately after 4-week intervention training
Primary	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.	Immediately after 4-week intervention training
Primary	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.	Immediately after 4-week intervention training
Primary	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).	Baseline, One-year after 4-week intervention training
Primary	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.	Baseline, One-year after 4-week intervention training
Primary	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).	Baseline, One-year after 4-week intervention training
Primary	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.	Baseline, One-year after 4-week intervention training
Primary	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.	One-year after 4-week intervention training
Primary	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.	One-year after 4-week intervention training
Primary	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.	Baseline, Immediately after 4-week intervention training
Primary	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.	Baseline, Immediately after 4-week intervention training
Primary	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.	Baseline, Immediately after 4-week intervention training
Primary	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.	Baseline, One-year after 4-week intervention training
Primary	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.	Baseline, One-year after 4-week intervention training
Primary	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.	Baseline, One-year after 4-week intervention training
Primary	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.	Baseline, Immediately after 4-week intervention training
Primary	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.	Baseline, Immediately after 4-week intervention training
Primary	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.	Baseline, One-year after 4-week intervention training
Primary	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.	Baseline, One-year after 4-week intervention training
Secondary	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.	Baseline, Immediately after 4-week intervention training
Secondary	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.	Baseline, One-year after 4-week intervention training
Secondary	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.	Baseline, Immediately after 4-week intervention training
Secondary	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.	Baseline, One-year after 4-week intervention training
Secondary	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.	Baseline, Immediately after 4-week intervention training
Secondary	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.	Baseline, One-year after 4-week intervention training
Secondary	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.	Baseline, Immediately after 4-week intervention training
Secondary	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.	Baseline, One-year after 4-week intervention training
Secondary	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.	Baseline, Immediately after 4-week intervention training
Secondary	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.	Baseline, One-year after 4-week intervention training