Clinical trial NCT01165463: Iowa Healthy and Active Minds Study
Official title: RCT of Two Speed of Processing Modes to Prevent Cognitive Decline in Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Visual Processing Speed
Keywords: Aging
Healthy
Lead sponsor: University of Iowa
Sponsor class: OTHER
Collaborators: name: National Institute on Aging (NIA)
First posted: 2010-07-19
Enrollment: 681
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Useful Field of View Test
timeFrame: 12 months
Secondary outcomes:
measure: Digit Vigilance Test
timeFrame: 12 months
measure: Symbol Digit Modalities Test
timeFrame: 12 Months
measure: Controlled Oral Word Association Test
timeFrame: 12 Months
measure: Comprehensive Trail Making Test
timeFrame: 12 Months
measure: Stroop
timeFrame: 12 months
Other outcomes:
Locations:
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
Study officials:
affiliation: University of Iowa
name: Fredric D Wolinksy, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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;1(2):e000225. doi: 10.1136/bmjopen-2011-000225. Print 2011.
citation: 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.0061624. Print 2013.
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 trial. J Aging Health. 2015 Mar;27(2):334-54. doi: 10.1177/0898264314550715. Epub 2014 Sep 19.
citation: Wolinsky FD, Vander Weg MW, Howren MB, Jones MP, Dotson MM. Effects of cognitive speed of processing training on a composite neuropsychological outcome: results at one-year from the IHAMS randomized controlled trial. Int Psychogeriatr. 2016 Feb;28(2):317-30. doi: 10.1017/S1041610215001428. Epub 2015 Sep 14.