ACTIVE: Advanced Cognitive Training for Independent and Vital Elderly (ACTIVE)
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ClinicalTrials.gov Identifier: NCT00298558 |
Recruitment Status :
Completed
First Posted : March 2, 2006
Results First Posted : February 24, 2014
Last Update Posted : April 16, 2014
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Condition or disease | Intervention/treatment | Phase |
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Aging Healthy | Behavioral: Cognitive Training | Phase 2 Phase 3 |

Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 2832 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Participant) |
Primary Purpose: | Prevention |
Official Title: | Trial of a Cognitive Intervention for Older Adults |
Study Start Date : | March 1998 |
Actual Primary Completion Date : | December 2010 |
Actual Study Completion Date : | December 2010 |
Arm | Intervention/treatment |
---|---|
Active Comparator: Memory Training
Memory training focused on verbal episodic memory. Participants were taught mnemonic strategies for remembering lists and sequences of items, text material, and main ideas and details of stories and other text-based information.
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Behavioral: Cognitive Training
Memory, Reasoning, or Speed of Processing cognitive training interventions |
Active Comparator: Reasoning Training
Reasoning training focused on the ability to solve problems that follow a serial pattern. Participants were taught strategies to identify the pattern or sequence required to solve a problem.
|
Behavioral: Cognitive Training
Memory, Reasoning, or Speed of Processing cognitive training interventions |
Active Comparator: Speed of Processing Training
Speed of processing training focused on visual search and the ability to identify and locate visual information quickly in a divided attention format. Participants practiced increasingly complex speeded tasks on a computer.
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Behavioral: Cognitive Training
Memory, Reasoning, or Speed of Processing cognitive training interventions |
Placebo Comparator: Control
This group did not complete any cognitive training interventions
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Behavioral: Cognitive Training
Memory, Reasoning, or Speed of Processing cognitive training interventions |
- Changes in Cognitive Abilities of Memory From Baseline to Year 10 [ Time Frame: Up to 10 years ]Memory outcome was computed as the summation of Rey Auditory-Verbal Learning Test (AVLT), the Hopkins Verbal Learning Test (HVLT), and the Rivermead Behavioral Paragraph Recall test immediate recall. The possible range of the memory outcome is 0 to 132. Higher values represent a better outcome. Changes in outcome were computed as "10 year minus baseline" and the negative values indicate the decline from baseline.
- Changes in Cognitive Abilities of Reasoning From Baseline to Year 10 [ Time Frame: Up to 10 years ]Reasoning outcome was computed as the summation of total correct for Letter Series, Letter Sets, and Word Series. The possible range of the reasoning outcome is 0 to 75. Higher values represent a better outcome. Changes in outcome were computed as "10 year minus baseline" and the negative values indicate the decline from baseline.
- Changes in Cognitive Abilities of Speed of Processing From Baseline to Year 10 [ Time Frame: Up to 10 years ]Speed of processing outcome was computed as the summation of three Useful Field of View tasks requiring identification and localization of information, with 75% accuracy, under varying levels of cognitive demand. For the analysis, the reversed score was used and the possible range of the reversed speed of processing outcome is 0 to 1500. Higher values for the reversed scores represent a better outcome. Changes in outcome were computed as "10 year minus baseline" and the negative values indicate the decline from baseline.
- Changes in Instrumental Activities of Daily Living (IADL) Difficulty From Baseline to Year 10 [ Time Frame: Up to 10 years ]The self-reported measure of everyday IADL function was the summation of the IADL difficulty sub-scores from the Minimum Dataset - Home Care (MDS-HC) which assesses performance in the past 7 days on 19 daily tasks spanning meal preparation, housework, finances, health care, telephone, shopping, travel, and need for assistance in dressing, personal hygiene, and bathing. For the analysis, the reversed score was used and the possible range of the reversed everyday IADL function outcome is 0 to 38. Higher values for the reversed scores represent a better outcome. Changes in outcome were computed as "10 year minus baseline" and the negative values indicate the decline from baseline.
- Changes in Everyday Problem Solving From Baseline to Year 10 [ Time Frame: Up to 10 years ]Everyday Problem Solving was computed as the summation of the Everyday Problems Test (EPT) and Observed Tasks of Daily Living (OTDL). The possible range of the everyday problem solving outcome is 0 to 56. Higher values represent a better outcome. Changes in outcome were computed as "10 year minus baseline" and the negative values indicate the decline from baseline.
- Changes in Everyday Speed of Processing From Baseline to Year 10 [ Time Frame: Up to 10 years ]Everyday Speed of processing was computed as the summation of Complex Reaction Time (CRT) and Timed IADL (TIADL). For the analysis, the reversed score was used and the possible range of the reversed everyday speed of processing outcome is -3 to 100. Higher values for the reversed scores represent a better outcome. Changes in outcome were computed as "10 year minus baseline" and the negative values indicate the decline from baseline.
- Changes in Health-related Quality of Life (HRQol), Driving Function, Health Service Use [ Time Frame: 10th Year ]To determine if the cognitive interventions have beneficial effects on the distal outcomes of driving safety, personal care activities of daily living, health service utilization, and mortality.
- Examine Health, Genetic and Cognitive Moderators [ Time Frame: 10th Year ]To examine heath, genetic, and cognitive moderators (including cardiovascular disease,diabetes, depression, Apolipoprotein E (APOE) genotype, and low cognition and engagement) in individual response to training.
- Estimate the Effects of ACTIVE Training to General Population [ Time Frame: 10th Year ]To estimate and project the effects of ACTIVE training to the general population of older adults by linking the measures and outcomes of ACTIVE to the Health and Retirement Study(and its subsidiary studies), a population-based, nationally-representative cohort.

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Ages Eligible for Study: | 65 Years and older (Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Age 65 or older
- Mini-Mental State Examination (MMSE) score 23 or greater
- Vision scored greater than 20/50
- Minimal dependence in hygiene, bathing, and dressing
Exclusion Criteria:
- Significant decline in cognitive skills, physical abilities, or functional independence
- Inability to complete study activities as evidenced by MMSE and vision scores lower than Inclusion Criteria requirement
- Diagnosis of Alzheimer's disease
- Stroke in previous 12 months
- Cancer with limited life expectance
- Current chemotherapy or radiation treatment
- Communication problems
- Planned move from study area
- Scheduling conflicts that would preclude participation in study activities
- Prior involvement in similar cognitive training studies

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00298558
United States, Alabama | |
University of Alabama at Birmingham | |
Birmingham, Alabama, United States, 35294 | |
United States, Indiana | |
Indiana University | |
Indianapolis, Indiana, United States, 46202 | |
United States, Maryland | |
Johns Hopkins University | |
Baltimore, Maryland, United States, 21205 | |
Johns Hopkins University | |
Cumberland, Maryland, United States, 21205 | |
United States, Massachusetts | |
Hebrew Rehabilitation Center for the Aged | |
Boston, Massachusetts, United States, 02131 | |
United States, Michigan | |
Wayne State University | |
Detroit, Michigan, United States, 48202 | |
United States, Pennsylvania | |
Pennsylvania State University | |
University Park, Pennsylvania, United States, 16802 |
Principal Investigator: | Karlene Ball, PhD | University of Alabama at Birmingham | |
Principal Investigator: | Frederick Unverzagt, PhD | Indiana University | |
Principal Investigator: | George Rebok, PhD | Johns Hopkins University | |
Principal Investigator: | John Morris, PhD | Hebrew Senior Life | |
Principal Investigator: | Sharon L. Tennstedt, PhD | HealthCore-NERI | |
Principal Investigator: | Michael Marsiske, PhD | Wayne State University | |
Principal Investigator: | Sherry Willis, PhD | Penn State University |
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | HealthCore-NERI |
ClinicalTrials.gov Identifier: | NCT00298558 |
Other Study ID Numbers: |
IA0091 U01NR004507 ( U.S. NIH Grant/Contract ) U01NR004508 ( U.S. NIH Grant/Contract ) U01AG014260 ( U.S. NIH Grant/Contract ) U01AG014282 ( U.S. NIH Grant/Contract ) U01AG014263 ( U.S. NIH Grant/Contract ) U01AG014289 ( U.S. NIH Grant/Contract ) U01AG014276 ( U.S. NIH Grant/Contract ) |
First Posted: | March 2, 2006 Key Record Dates |
Results First Posted: | February 24, 2014 |
Last Update Posted: | April 16, 2014 |
Last Verified: | January 2014 |
cognition disorder cognitive behavior therapy functional ability |