Iowa Healthy and Active Minds Study

Visual Processing Speed Clinical Trial

— IHAMS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01165463
• Other study ID #: 200908789
• Secondary ID: 1RC1AG035546-01
• Status: Completed
• Phase: N/A
• Start date: September 2009
• Est. completion date: March 2012

Study information

• Verified date: June 2019
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 681
• Est. completion date: March 2012
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Visual Processing Speed

Intervention

Behavioral:
• SOPT basic training
10 hours of basic training
• Crossword Puzzles
Subjects train with puzzles 10 hrs in lab.
• SOPT booster training
4 hours of subsequent booster-training

Locations

Country	Name	City	State
United States	University of Iowa	Iowa City	Iowa

Sponsors (2)

Lead Sponsor	Collaborator
Fredric D Wolinsky	National Institute on Aging (NIA)

Country where clinical trial is conducted

United States, 

References & Publications (4)

Wolinsky FD, Vander Weg MW, Howren MB, Jones MP, Dotson MM. A randomized controlled trial of cognitive training using a visual speed of processing intervention in middle aged and older adults. PLoS One. 2013 May 1;8(5):e61624. doi: 10.1371/journal.pone.00 — View Citation

Wolinsky FD, Vander Weg MW, Howren MB, Jones MP, Dotson MM. The effect of cognitive speed of processing training on the development of additional IADL difficulties and the reduction of depressive symptoms: results from the IHAMS randomized controlled tria — View Citation

Wolinsky FD, Vander Weg MW, Howren MB, Jones MP, Martin R, Luger TM, Duff K, Dotson MM. Interim analyses from a randomised controlled trial to improve visual processing speed in older adults: the Iowa Healthy and Active Minds Study. BMJ Open. 2011 Nov 21; — View Citation

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. doi: 10.1136/bmjopen-2011-000218. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Useful Field of View Test	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	Digit Vigilance Test	Subject crosses out all 6's on an 8 x 11.5 page of random numbers while being timed.	12 months
Secondary	Symbol Digit Modalities Test	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
Secondary	Controlled Oral Word Association Test	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
Secondary	Comprehensive Trail Making Test	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
Secondary	Stroop	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