Iowa Healthy and Active Minds Study (IHAMS)
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | July 13, 2010 | ||||
| Last Updated Date | December 19, 2012 | ||||
| Start Date ICMJE | September 2009 | ||||
| Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
Useful Field of View Test [ Time Frame: 12 months ] [ Designated as safety issue: No ] 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. |
||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01165463 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
|
||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Iowa Healthy and Active Minds Study | ||||
| Official Title ICMJE | RCT of Two Speed of Processing Modes to Prevent Cognitive Decline in Older Adults | ||||
| Brief Summary | The investigators will formally test seven key hypotheses (Hn) from an intent-to-treat perspective in this second-generation study based on results from ACTIVE (Advanced Cognitive Training for Independent and Vital Elderly). H1 involves a replication of ACTIVE (i.e., onsite delivery) in which the basic and booster effects of speed of processing vs. the attention control group are pooled. H1 hypothesizes statistically significant evidence to support the benefit of being assigned to G1 (on-site training) vs. the attention control group. H2 and H3 are designed to separate the basic effect (H2) from the basic plus booster effect (H3) among the onsite delivery group (G1). In this analysis, the investigators separate out (i.e., do not pool) the G1 boostered group from the G1 non-boostered group, and compare both to the attention control group. The investigators expect to find statistically significant evidence to support the benefit of being assigned to either half of the G1 group, indicating the benefit of training vs. attention control regardless of boostering. That is, onsite training works regardless of whether you were in the boostering group or not, vs. the attention control group. H4 represents the test of the at home delivery of speed of processing (G3) vs. the attention control group. 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. H5 and H6 evaluate the different modes of implementing the speed of processing intervention. H5 represents a head-to-head comparison of the basic onsite delivery vs. the at home delivery of the speed of processing intervention. H5 hypothesizes that the at-home (G3) effect will be greater than the on-site (G1) effect given the potential for individual dosing, maintenance, etc. in the at home delivery group. H6 represents a head-to-head comparison of the basic plus booster onsite delivery (boostered G1) vs. the at home delivery of the speed of processing intervention. H6 hypothesizes that given the potential for individual dosing, maintenance, etc. in the at-home delivery group, at-home delivery will do better than the four-session maximum in the onsite booster group. Finally, H7 represents the head-to-head test of onsite basic to onsite basic plus booster training . H7 hypothesizes that the difference between the two will reflect the value of booster training. The investigators will also replicate all of the investigators analyses within each age strata (50-64 vs. > 65) and compare effect sizes across strata. |
||||
| 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 aged 50 years old or older to three groups. Group G1 (N=264) will receive the value-added speed of processing intervention in 10 hours of onsite sessions as was done in the previous multi-site, national study known as ACTIVE (Advanced Cognitive Training for Vital Elderly). Group G1 will be further randomized to one half (G1a) not receiving booster sessions at 11 months post-training and one half (G1b) receiving 4 hours of onsite booster sessions at 11-months. Group G2 (N=168) will be the attention control group and will receive 10 hours of onsite sessions using a computerized cross-word puzzle program. Group G3 (N=168) will be shown how to operate the value-added speed of processing software on site, and will then be sent home to use it for at least nine hours but more if they wish on their own personal computer. 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. |
||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 0 | ||||
| Study Design ICMJE | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Prevention |
||||
| Condition ICMJE | Visual Processing Speed | ||||
| Intervention ICMJE |
|
||||
| Study Arm (s) |
|
||||
| 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. | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 681 | ||||
| Completion Date | March 2012 | ||||
| Primary Completion Date | December 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 50 Years and older | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01165463 | ||||
| Other Study ID Numbers ICMJE | 200908789, 1RC1AG035546-01 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Frederick D Wolinsky, University of Iowa | ||||
| Study Sponsor ICMJE | University of Iowa | ||||
| Collaborators ICMJE | National Institute on Aging (NIA) | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | University of Iowa | ||||
| Verification Date | December 2012 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||