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Completed

NCT Number: NCT01165463

Iowa Healthy and Active Minds Study

This is second-generation study based on results from ACTIVE (Advanced Cognitive Training for Independent and Vital Elderly). This four-arm study is known as IHAMS (the Iowa Healthy and Active Minds Study). The investigators will formally test from an intent-to-treat perspective for differences on the primary and secondary outcomes based on whether participants were randomized to the basic on-site speed of processing training (SOPT) group (G1), to the on-site basic SOPT plus subsequent booster-training group (G2), to the basic at-home SOPT group (G3), or to the basic attention-control group (G4). Basic training involves 10 hours of either the SOPT or attention-control training during the first 6 weeks of participation. Booster-training involves 4 additional hours of SOPT training at 11 months of participation.

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Key information

Conditions

Visual Processing Speed

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Iowa

Iowa City, Iowa, 52242, United States

About this study

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 to four treatment arms separately within two age strata (50-64, and 65 and older).

The four groups include: G1, basic on-site SOPT; G2, on-site basic SOPT plus subsequent booster-training group; G3, basic at-home SOPT; or G4, basic attention-control group. Basic training involves 10 hours of either the SOPT or attention-control training during the first 6 weeks of participation. Booster-training involves 4 additional hours of SOPT training at 11 months of participation.

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.

There are seven key hypotheses (Hn). H1 involves a replication of ACTIVE (i.e., on-site SOPT delivery, with or without booster-training) in which groups G1 and G2 are combined vs. the attention control group and hypothesizes statistically significant evidence to support the benefit of being assigned to on-site training vs. the attention control group.

H2 and H3 are designed to separate the basic training effect (H2) from the basic plus booster-training effect (H3) among the on-site delivery groups (G1 and G2) vs. the attention control group (G4), and hypothesizes benefits of SOPT training vs. attention control regardless of booster-training.

H4 represents the test of the at-home delivery of SOPT training (G3) vs. the attention control group (G4). 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 (G4).

H5 and H6 evaluate the different modes of implementing the speed of processing intervention. H5 represents a head-to-head comparison of the basic on-site delivery vs. the at-home delivery of the SOPT intervention. H5 hypothesizes that the effect of at-home SOPT training (G3) will be greater than the effect of on-site SOPT training (G1).

H6 represents a head-to-head comparison of the on-site basic plus booster SOPT training (G2) vs. the at-home delivery of the SOPT intervention. H6 hypothesizes that the effect for at-home SOPT (G3) will be larger than that for the on-site SOPT with booster-training group (G2).

Finally, H7 represents the head-to-head test of on-site basic SOPT (G1) to on-site basic plus booster training SOPT group (G2) . H7 hypothesizes that the difference between the two will reflect the value of booster training.

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SOPT basic training

Behavioral

10 hours of basic training

Crossword Puzzles

Behavioral

Subjects train with puzzles 10 hrs in lab.

SOPT booster training

Behavioral

4 hours of subsequent booster-training

Primary outcomes

  1. Useful Field of View Test

    Time frame: 12 months

    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.

Secondary outcomes

  1. Digit Vigilance Test

    Time frame: 12 months

    Subject crosses out all 6's on an 8 x 11.5 page of random numbers while being timed.

  2. Symbol Digit Modalities Test

    Time frame: 12 Months

    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.

  3. Controlled Oral Word Association Test

    Time frame: 12 Months

    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.

  4. Comprehensive Trail Making Test

    Time frame: 12 Months

    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.

  5. Stroop

    Time frame: 12 months

    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.

Sponsors and collaborators

Lead sponsor

Fredric D Wolinsky

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

RCT of Two Speed of Processing Modes to Prevent Cognitive Decline in Older Adults

Acronym: IHAMS

Important dates

Study start
2009
Primary completion
2011
Study completion
2012
First posted
Jul 19, 2010
Registry last updated
Jun 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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