NCT03141281

Brief Summary

The study will compare the effect of broad and directed (narrow) technology-based training on basic perceptual and cognitive abilities in older adults and on the performance of simulated tasks of daily living including driving and fraud avoidance.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
238

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 1, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 5, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

September 20, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 3, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 3, 2019

Completed
1.8 years until next milestone

Results Posted

Study results publicly available

June 7, 2021

Completed
Last Updated

June 7, 2021

Status Verified

May 1, 2021

Enrollment Period

2 years

First QC Date

May 1, 2017

Results QC Date

February 1, 2021

Last Update Submit

May 11, 2021

Conditions

Keywords

agingcognitive abilityIADLdrivingfinancial fraudperceptionattentionmemory

Outcome Measures

Primary Outcomes (22)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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 Outcomes (10)

  • Technology Proficiency Post Training

    Baseline, Immediately after 4-week intervention training

  • Technology Proficiency at One Year

    Baseline, One-year after 4-week intervention training

  • Numeracy Post Training

    Baseline, Immediately after 4-week intervention training

  • Numeracy at One Year

    Baseline, One-year after 4-week intervention training

  • Reasoning Ability Post Training

    Baseline, Immediately after 4-week intervention training

  • +5 more secondary outcomes

Study Arms (4)

BrainHQ

EXPERIMENTAL

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

Rise of Nations

EXPERIMENTAL

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

IADL training

EXPERIMENTAL

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 Control

ACTIVE COMPARATOR

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

BrainHQBEHAVIORAL

BrainHQ

BrainHQ
Rise of NationsBEHAVIORAL

Rise of Nations

Rise of Nations
IADL TrainingBEHAVIORAL

IADL Training

IADL training
Active ControlBEHAVIORAL

Puzzle solving

Active Control

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersYes
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Florida State University

Tallahassee, Florida, 32306-4301, United States

Location

Related Publications (2)

  • 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.

Results Point of Contact

Title
Dr. Neil Charness
Organization
Florida State University

Study Officials

  • Neil Charness, PhD

    Florida State University

    PRINCIPAL INVESTIGATOR
  • Walter Boot, PhD

    Florida State University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Assessors will be blinded to study condition when administering the tests to participants
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Model Details: Random assignment to one of four treatment groups at study entry
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator, Professor of Psychology

Study Record Dates

First Submitted

May 1, 2017

First Posted

May 5, 2017

Study Start

September 20, 2017

Primary Completion

September 3, 2019

Study Completion

September 3, 2019

Last Updated

June 7, 2021

Results First Posted

June 7, 2021

Record last verified: 2021-05

Locations