Trial record 1 of 1 for:    Speed of Processing Modes to Prevent Cognitive Decline in Older Adults
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Iowa Healthy and Active Minds Study (IHAMS)

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Frederick D Wolinsky, University of Iowa
ClinicalTrials.gov Identifier:
NCT01165463
First received: July 13, 2010
Last updated: December 19, 2012
Last verified: December 2012

July 13, 2010
December 19, 2012
September 2009
December 2011   (final data collection date for primary outcome measure)
Useful Field of View Test [ Time Frame: 12 months ] [ Designated as safety issue: No ]
The Useful Field of View (UFOV) is a computer-administered test of functional vision and visual attention. UFOV consists of three subtests which assess speed of visual processing under increasingly complex task demands. The examinee must detect, identify, and localize briefly presented targets.
Same as current
Complete list of historical versions of study NCT01165463 on ClinicalTrials.gov Archive Site
  • Digit Vigilance Test [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Subject crosses out all 6's on an 8 x 11.5 page of random numbers while being timed.
  • Symbol Digit Modalities Test [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    Subject matches a number to a symbol corresponding to a key on the top of the page. They are timed and allowed 90 to complete.
  • Controlled Oral Word Association Test [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    Subject states all the ordinary words they can think of that start with the letter C while being timed for 60 seconds. They repeat this task with the letters F and L.
  • Comprehensive Trail Making Test [ Time Frame: 12 Months ] [ Designated as safety issue: No ]
    Both parts of the Trail Making Test consist of 25 circles distributed over a sheet of paper. In Part A, the circles are numbered 1 - 25, and the patient should draw lines to connect the numbers in ascending order. In Part B, the circles include both numbers (1 - 13) and letters (A - L); as in Part A, the patient draws lines to connect the circles in an ascending pattern, but with the added task of alternating between the numbers and letters (i.e., 1-A-2-B-3-C, etc.) They are timed until completion.
  • Stroop [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Subject must read aloud. Part A- Read the words on the page, Part B - Read the colors on the page, and Part C - Say the color of the ink the words are printed in. Each part is timed giving subject 45 seconds per part.
Not Provided
Not Provided
Not Provided
 
Iowa Healthy and Active Minds Study
RCT of Two Speed of Processing Modes to Prevent Cognitive Decline in Older Adults

The investigators will formally test seven key hypotheses (Hn) from an intent-to-treat perspective in this second-generation study based on results from ACTIVE (Advanced Cognitive Training for Independent and Vital Elderly).

H1 involves a replication of ACTIVE (i.e., onsite delivery) in which the basic and booster effects of speed of processing vs. the attention control group are pooled. H1 hypothesizes statistically significant evidence to support the benefit of being assigned to G1 (on-site training) vs. the attention control group.

H2 and H3 are designed to separate the basic effect (H2) from the basic plus booster effect (H3) among the onsite delivery group (G1). In this analysis, the investigators separate out (i.e., do not pool) the G1 boostered group from the G1 non-boostered group, and compare both to the attention control group. The investigators expect to find statistically significant evidence to support the benefit of being assigned to either half of the G1 group, indicating the benefit of training vs. attention control regardless of boostering. That is, onsite training works regardless of whether you were in the boostering group or not, vs. the attention control group.

H4 represents the test of the at home delivery of speed of processing (G3) vs. the attention control group. H4 hypothesizes that there will be statistically significant evidence indicating the benefit of being assigned to G3 (at home training) vs. the attention control group.

H5 and H6 evaluate the different modes of implementing the speed of processing intervention.

H5 represents a head-to-head comparison of the basic onsite delivery vs. the at home delivery of the speed of processing intervention. H5 hypothesizes that the at-home (G3) effect will be greater than the on-site (G1) effect given the potential for individual dosing, maintenance, etc. in the at home delivery group.

H6 represents a head-to-head comparison of the basic plus booster onsite delivery (boostered G1) vs. the at home delivery of the speed of processing intervention. H6 hypothesizes that given the potential for individual dosing, maintenance, etc. in the at-home delivery group, at-home delivery will do better than the four-session maximum in the onsite booster group.

Finally, H7 represents the head-to-head test of onsite basic to onsite basic plus booster training . H7 hypothesizes that the difference between the two will reflect the value of booster training.

The investigators will also replicate all of the investigators analyses within each age strata (50-64 vs. > 65) and compare effect sizes across strata.

In this study, our specific aims are to conduct a randomized controlled trial (RCT) with one-year follow-up that can be fully completed within the NIH Challenge Grant two-year period. The goal of the RCT is to improve cognitive performance among older adults to enhance their quality of life now and into the future. We will randomize 600 participants aged 50 years old or older to three groups. Group G1 (N=264) will receive the value-added speed of processing intervention in 10 hours of onsite sessions as was done in the previous multi-site, national study known as ACTIVE (Advanced Cognitive Training for Vital Elderly). Group G1 will be further randomized to one half (G1a) not receiving booster sessions at 11 months post-training and one half (G1b) receiving 4 hours of onsite booster sessions at 11-months. Group G2 (N=168) will be the attention control group and will receive 10 hours of onsite sessions using a computerized cross-word puzzle program. Group G3 (N=168) will be shown how to operate the value-added speed of processing software on site, and will then be sent home to use it for at least nine hours but more if they wish on their own personal computer. Our primary outcome measure is speed of processing, and we will use several reliable and valid instruments to provide a multidimensional assessment, including the Useful Field of View Test, the Symbol Digit Modalities Test, the Trail Making Test, the Controlled Oral Word Association Test, the Digit Vigilance Test, and the Stroop Color and Word Test.

Interventional
Phase 0
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Prevention
Visual Processing Speed
  • Behavioral: Speed of Processing training
    10 hrs of training in lab
  • Behavioral: Speed of Processing training
    Subjects train 10 hrs at home on their own computer.
  • Behavioral: Crossword Puzzles
    Subjects train with puzzles 10 hrs in lab.
  • Experimental: Clinic-based speed of processing training
    Subjects are training in our lab.
    Intervention: Behavioral: Speed of Processing training
  • Experimental: Home-based speed of processing training
    Subjects do training at home using their home computer.
    Intervention: Behavioral: Speed of Processing training
  • Active Comparator: Crossword Puzzles
    Subjects train with crossword puzzles in our lab.
    Intervention: Behavioral: Crossword Puzzles
Wolinsky FD, Vander Weg MW, Howren MB, Jones MP, Martin R, Luger TM, Duff K, Goerdt C, Wolfe S, Dotson MM. Protocol for a randomised controlled trial to improve cognitive functioning in older adults: the Iowa Healthy and Active Minds Study. BMJ Open. 2011 Jan 1;1(2):e000218.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
681
March 2012
December 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • 50 years of age or older
  • Patient of the FCC in Family Medicine or General Internal Medicine Clinic at UIHC
  • No known memory problems

Exclusion Criteria:

  • Significant vision impairments
  • Lack of access to a computer or owns a MAC
  • Lives more than 37 miles from the lab
  • Traumatic Brain Injury or severe stroke
Both
50 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01165463
200908789, 1RC1AG035546-01
Yes
Frederick D Wolinsky, University of Iowa
University of Iowa
National Institute on Aging (NIA)
Principal Investigator: Fredric D Wolinksy, Ph.D. University of Iowa
University of Iowa
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP