Visual Processing Speed Clinical Trial
Official title:
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.
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.
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| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Not yet recruiting |
NCT05703360 -
Effectiveness of AV-stimulation in Immersive VR to Improve Visual Perception and Driving Performance
|
N/A |