Visual Processing SpeedIHAMSNCT01165463
Iowa Healthy and Active Minds Study
A study testing SOPT basic training, Crossword Puzzles and SOPT booster training in people with Visual Processing Speed, run by Fredric D Wolinsky at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Visual Processing Speed
- What is being tested?
- SOPT basic training, Crossword Puzzles and SOPT booster training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 681 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2009to Mar 2012
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 50 years of age or older
- Patient of the FCC in Family Medicine or General Internal Medicine Clinic at UIHC
- No known memory problems
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Visual Processing Speed
- Being tested
- SOPT basic training, Crossword Puzzles, SOPT booster training
- Keywords
- Aging, Healthy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SOPT basic trainingBehavioural
10 hours of basic training
Crossword PuzzlesBehavioural
Subjects train with puzzles 10 hrs in lab.
SOPT booster trainingBehavioural
4 hours of subsequent booster-training
| Study group | Role | What they receive |
|---|---|---|
| Clinic-based SOPT basic training | Experimental | Clinic-based SOPT basic training for 10 hours. Receives: Behavioral: SOPT basic training |
| Home-based SOPT basic training | Experimental | Home-based SOPT basic training for 10 hours. Receives: Behavioral: SOPT basic training |
| Crossword Puzzles Training | Active comparator | Crossword puzzles training for 10 hours in our lab. Receives: Behavioral: Crossword Puzzles |
| SOPT basic and SOPT booster-training | Experimental | Clinic-based SOPT basic training and SOPT booster training. Receives: Behavioral: SOPT basic training; Behavioral: SOPT booster training |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (5)
Digit Vigilance Test
Subject crosses out all 6's on an 8 x 11.5 page of random numbers while being timed.
Measured: 12 months
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.
Measured: 12 Months
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.
Measured: 12 Months
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.
Measured: 12 Months
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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2010 (estimated)
- Study startSep 2009
- Primary completionDec 2011
- Study completionMar 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Visual Processing SpeedStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 681 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fredric D Wolinsky
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Sponsor-investigator, Fredric D Wolinsky, University of Iowa
- Investigators
- Fredric D Wolinksy, Ph.D., Principal investigator, University of Iowa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01165463
- Sponsor's protocol ID
- 200908789
- Other IDs
- 1RC1AG035546-01
- Acronym
- IHAMS
- Status last verified
- Jun 2019
- First submitted
- 13 Jul 2010
- Last updated
- 21 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 22021885Wolinsky 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.
PubMed 22106377Wolinsky 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.
PubMed 23650501Wolinsky 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.
PubMed 25239928Wolinsky 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.
PubMed 26364892
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- RCT of Two Speed of Processing Modes to Prevent Cognitive Decline in Older Adults
- ClinicalTrials.gov ID
- NCT01165463
- Acronym / sponsor ID
- IHAMS / 200908789
- Conditions
- Visual Processing Speed
- Keywords
- Aging, Healthy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 681 participants (actual)
- Lead sponsor
- Fredric D WolinskyUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- Sep 2009
- Primary completion
- Dec 2011 (actual)
- Study completion
- Mar 2012 (actual)
- First posted
- 19 Jul 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Clinic-based SOPT basic training | Experimental | Behavioral: SOPT basic trainingClinic-based SOPT basic training for 10 hours. |
| Home-based SOPT basic training | Experimental | Behavioral: SOPT basic trainingHome-based SOPT basic training for 10 hours. |
| Crossword Puzzles Training | Active comparator | Behavioral: Crossword PuzzlesCrossword puzzles training for 10 hours in our lab. |
| SOPT basic and SOPT booster-training | Experimental | Behavioral: SOPT basic training, Behavioral: SOPT booster trainingClinic-based SOPT basic training and SOPT booster training. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 50 years of age or older
- Patient of the FCC in Family Medicine or General Internal Medicine Clinic at UIHC
- No known memory problems
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SOPT basic training10 hours of basic training | Behavioural | Clinic-based SOPT basic training, Home-based SOPT basic training, SOPT basic and SOPT booster-training |
| Crossword PuzzlesSubjects train with puzzles 10 hrs in lab. | Behavioural | Crossword Puzzles Training |
| SOPT booster training4 hours of subsequent booster-training | Behavioural | SOPT basic and SOPT booster-training |
Primary outcome
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.
5 secondary outcomes
Digit Vigilance Test
Time frame: 12 months
Symbol Digit Modalities Test
Time frame: 12 Months
Controlled Oral Word Association Test
Time frame: 12 Months
Comprehensive Trail Making Test
Time frame: 12 Months
Stroop
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2019.
- Background: PubMed 22021885Wolinsky 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.
- Results publication: PubMed 22106377Wolinsky 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.
- Results publication: PubMed 23650501Wolinsky 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.
- Results publication: PubMed 25239928Wolinsky 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.
- Derived from this study: PubMed 26364892Wolinsky 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fredric D Wolinksy, Ph.D. principal investigator
University of Iowa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SOPT basic training, Crossword Puzzles and SOPT booster training in people with Visual Processing Speed, run by Fredric D Wolinsky at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Useful Field of View Test (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01165463, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2019.