Iowa Healthy and Active Minds Study (IHAMS)

June 19, 2019 updated by: Fredric D Wolinsky

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Actual)

681

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

  • United States
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa

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

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Clinic-based SOPT basic training
Clinic-based SOPT basic training for 10 hours.
Behavioral: SOPT basic training
10 hours of basic training
Experimental: Home-based SOPT basic training
Home-based SOPT basic training for 10 hours.
Behavioral: SOPT basic training
10 hours of basic training
Active Comparator: Crossword Puzzles Training
Crossword puzzles training for 10 hours in our lab.
Behavioral: Crossword Puzzles
Subjects train with puzzles 10 hrs in lab.
Experimental: SOPT basic and SOPT booster-training
Clinic-based SOPT basic training and SOPT booster training.
Behavioral: SOPT basic training
10 hours of basic training
Behavioral: SOPT booster training
4 hours of subsequent booster-training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months
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.
12 Months
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.
12 Months
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.
12 Months
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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fredric D Wolinsky

Collaborators

National Institute on Aging (NIA)

Investigators

  • Principal Investigator: Fredric D Wolinksy, Ph.D., University of Iowa

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

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

September 1, 2009

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

March 1, 2012

Study Registration Dates

First Submitted

July 13, 2010

First Submitted That Met QC Criteria

July 16, 2010

First Posted (Estimate)

July 19, 2010

Study Record Updates

Last Update Posted (Actual)

June 21, 2019

Last Update Submitted That Met QC Criteria

June 19, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 200908789
  • 1RC1AG035546-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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