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Trial record 2 of 2 for:    17565162 [PUBMED-IDS]

ACTIVE: Advanced Cognitive Training for Independent and Vital Elderly (ACTIVE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00298558
Recruitment Status : Completed
First Posted : March 2, 2006
Results First Posted : February 24, 2014
Last Update Posted : April 16, 2014
Sponsor:
Collaborators:
National Institute on Aging (NIA)
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
New England Research Institutes

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Prevention
Conditions Aging
Healthy
Intervention Behavioral: Cognitive Training
Enrollment 2832
Recruitment Details Recruitment occurred from March 1998 through October 1999 at six metropolitan field centers: University of Alabama at Birmingham, Boston Hebrew Rehabilitation Center for Aged (now Hebrew Senior Life), Indiana University School of Medicine, Johns Hopkins University, Pennsylvania State University, and Wayne State University.
Pre-assignment Details Eligibility and demographics were gathered at telephone screening.Health history, physical status, functional status, mental status, cognitive and function measures were gathered via in-person exams in individual and small-group formats at baseline.Eligible subjects were randomly assigned to one of three interventions or no-contact control group.
Arm/Group Title Memory Training Reasoning Training Speed of Processing Training Control
Hide Arm/Group Description 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. 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. 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. This group did not complete any cognitive training interventions
Period Title: Baseline
Started 711 705 712 704
Completed 711 705 712 704
Not Completed 0 0 0 0
Period Title: Intervention
Started 711 705 712 704
Completed 620 627 637 285
Not Completed 91 78 75 419
Period Title: Immediate Post Test
Started 711 705 712 704
Completed 640 629 653 639
Not Completed 71 76 59 65
Period Title: Booster
Started 372 371 370 0
Completed 283 301 295 0
Not Completed 89 70 75 0
Period Title: 1st Annual (A1)
Started 640 629 653 639
Completed 585 566 601 584
Not Completed 55 63 52 55
Period Title: 2nd Annual (A2)
Started 585 566 601 584
Completed 563 555 574 552
Not Completed 22 11 27 32
Period Title: 3rd Annual Booster
Started 372 371 370 0
Completed 250 243 230 0
Not Completed 122 128 140 0
Period Title: 3rd Annual (A3) and 5th Annual (A5)
Started 563 555 574 552
Completed 472 469 490 448
Not Completed 91 86 84 104
Period Title: 10th Annual (A10)
Started 472 469 490 448
Completed 300 316 319 285
Not Completed 172 153 171 163
Arm/Group Title Memory Training Reasoning Training Speed of Processing Training Control Total
Hide Arm/Group Description 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. 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. 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. This group did not complete any cognitive training interventions Total of all reporting groups
Overall Number of Baseline Participants 703 699 702 698 2802
Hide Baseline Analysis Population Description
Of 2832 randomized subjects, 30 subjects were randomized inappropriately in violation of the protocol and excluded from the analysis. Therefore, 2802 subjects were used for the baseline analysis.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 703 participants 699 participants 702 participants 698 participants 2802 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
>=65 years
703
 100.0%
699
 100.0%
702
 100.0%
698
 100.0%
2802
 100.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 703 participants 699 participants 702 participants 698 participants 2802 participants
73.5  (6.02) 73.5  (5.76) 73.4  (5.78) 74.0  (6.05) 73.6  (5.91)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 703 participants 699 participants 702 participants 698 participants 2802 participants
Female
537
  76.4%
537
  76.8%
538
  76.6%
514
  73.6%
2126
  75.9%
Male
166
  23.6%
162
  23.2%
164
  23.4%
184
  26.4%
676
  24.1%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 703 participants 699 participants 702 participants 698 participants 2802 participants
703 699 702 698 2802
1.Primary Outcome
Title Changes in Cognitive Abilities of Memory From Baseline to Year 10
Hide Description 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.
Time Frame Up to 10 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Of the randomized subjects, 943 subjects who had the memory outcome at year 10 were used.
Arm/Group Title Memory Training Reasoning Training Speed of Processing Training Control
Hide Arm/Group Description:
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.
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.
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.
This group did not complete any cognitive training interventions
Overall Number of Participants Analyzed 231 248 248 216
Mean (Standard Deviation)
Unit of Measure: units on a scale
-10.6  (28.3) -11.2  (26.3) -12.7  (25.5) -9.4  (29.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Memory Training, Control
Comments Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.43
Comments [Not Specified]
Method Mixed Models Analysis
Comments The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.
Method of Estimation Estimation Parameter Effect Size
Estimated Value 0.06
Confidence Interval (2-Sided) 99%
-0.14 to 0.27
Estimation Comments Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Reasoning Training, Control
Comments Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.17
Comments [Not Specified]
Method Mixed Models Analysis
Comments The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.
Method of Estimation Estimation Parameter Effect Size
Estimated Value -0.11
Confidence Interval (2-Sided) 99%
-0.31 to 0.10
Estimation Comments Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Speed of Processing Training, Control
Comments Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.52
Comments [Not Specified]
Method Mixed Models Analysis
Comments The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.
Method of Estimation Estimation Parameter Effect Size
Estimated Value -0.05
Confidence Interval (2-Sided) 99%
-0.25 to 0.15
Estimation Comments Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.
2.Primary Outcome
Title Changes in Cognitive Abilities of Reasoning From Baseline to Year 10
Hide Description 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.
Time Frame Up to 10 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Of the randomized subjects, 938 subjects who had the reasoning outcome at year 10 were used.
Arm/Group Title Memory Training Reasoning Training Speed of Processing Training Control
Hide Arm/Group Description:
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.
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.
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.
This group did not complete any cognitive training interventions
Overall Number of Participants Analyzed 230 246 248 214
Mean (Standard Deviation)
Unit of Measure: units on a scale
-3.23  (8.61) -0.049  (7.91) -3.94  (8.34) -3.04  (8.02)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Memory Training, Control
Comments Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.69
Comments [Not Specified]
Method Mixed Models Analysis
Comments The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.
Method of Estimation Estimation Parameter Effect Size
Estimated Value -0.02
Confidence Interval (2-Sided) 99%
-0.17 to 0.12
Estimation Comments Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Reasoning Training, Control
Comments Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method Mixed Models Analysis
Comments The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.
Method of Estimation Estimation Parameter Effect Size
Estimated Value 0.23
Confidence Interval (2-Sided) 99%
0.09 to 0.38
Estimation Comments Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Speed of Processing Training, Control
Comments Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.27
Comments [Not Specified]
Method Mixed Models Analysis
Comments The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.
Method of Estimation Estimation Parameter Effect Size
Estimated Value -0.06
Confidence Interval (2-Sided) 99%
-0.20 to 0.08
Estimation Comments Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.
3.Primary Outcome
Title Changes in Cognitive Abilities of Speed of Processing From Baseline to Year 10
Hide Description 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.
Time Frame Up to 10 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Of the randomized subjects, 879 subjects who had the speed outcome at year 10 were used.
Arm/Group Title Memory Training Reasoning Training Speed of Processing Training Control
Hide Arm/Group Description:
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.
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.
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.
This group did not complete any cognitive training interventions
Overall Number of Participants Analyzed 216 231 229 203
Mean (Standard Deviation)
Unit of Measure: units on a scale
-144.4  (228.6) -126.2  (253.6) 24.3  (252.1) -123.3  (277.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Memory Training, Control
Comments Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.45
Comments [Not Specified]
Method Mixed Models Analysis
Comments The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.
Method of Estimation Estimation Parameter Effect Size
Estimated Value -0.07
Confidence Interval (2-Sided) 99%
-0.29 to 0.16
Estimation Comments Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Reasoning Training, Control
Comments Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.95
Comments [Not Specified]
Method Mixed Models Analysis
Comments The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.
Method of Estimation Estimation Parameter Effect Size
Estimated Value 0.005
Confidence Interval (2-Sided) 99%
-0.22 to 0.23
Estimation Comments Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Speed of Processing Training, Control
Comments Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method Mixed Models Analysis
Comments The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.
Method of Estimation Estimation Parameter Effect Size
Estimated Value 0.66
Confidence Interval (2-Sided) 99%
0.43 to 0.88
Estimation Comments Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.
4.Primary Outcome
Title Changes in Instrumental Activities of Daily Living (IADL) Difficulty From Baseline to Year 10
Hide Description 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.
Time Frame Up to 10 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Of the randomized subjects, 1211 subjects who had the IADL outcome at year 10 were used.
Arm/Group Title Memory Training Reasoning Training Speed of Processing Training Control
Hide Arm/Group Description:
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.
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.
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.
This group did not complete any cognitive training interventions
Overall Number of Participants Analyzed 297 314 316 284
Mean (Standard Deviation)
Unit of Measure: units on a scale
-3.05  (7.38) -2.66  (6.31) -2.34  (5.62) -3.61  (7.67)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Memory Training, Control
Comments Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method Mixed Models Analysis
Comments The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.
Method of Estimation Estimation Parameter Effect Size
Estimated Value 0.48
Confidence Interval (2-Sided) 99%
0.12 to 0.84
Estimation Comments Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Reasoning Training, Control
Comments Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method Mixed Models Analysis
Comments The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.
Method of Estimation Estimation Parameter Effect Size
Estimated Value 0.38
Confidence Interval (2-Sided) 99%
0.02 to 0.74
Estimation Comments Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Speed of Processing Training, Control
Comments Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments [Not Specified]
Method Mixed Models Analysis
Comments The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.
Method of Estimation Estimation Parameter Effect Size
Estimated Value 0.36
Confidence Interval (2-Sided) 99%
0.01 to 0.72
Estimation Comments Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.
5.Primary Outcome
Title Changes in Everyday Problem Solving From Baseline to Year 10
Hide Description 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.
Time Frame Up to 10 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Of the randomized subjects, 1104 subjects who had the everyday problem solving outcome at year 10 were used.
Arm/Group Title Memory Training Reasoning Training Speed of Processing Training Control
Hide Arm/Group Description:
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.
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.
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.
This group did not complete any cognitive training interventions
Overall Number of Participants Analyzed 270 290 295 249
Mean (Standard Deviation)
Unit of Measure: units on a scale
-6.10  (9.75) -5.58  (9.56) -5.98  (9.32) -5.67  (9.85)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Memory Training, Control
Comments Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.97
Comments [Not Specified]
Method Mixed Models Analysis
Comments The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.
Method of Estimation Estimation Parameter Effect Size
Estimated Value 0.004
Confidence Interval (2-Sided) 99%
-0.23 to 0.24
Estimation Comments Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Reasoning Training, Control
Comments Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.86
Comments [Not Specified]
Method Mixed Models Analysis
Comments The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.
Method of Estimation Estimation Parameter Effect Size
Estimated Value -0.02
Confidence Interval (2-Sided) 99%
-0.25 to 0.22
Estimation Comments Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Speed of Processing Training, Control
Comments Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.93
Comments [Not Specified]
Method Mixed Models Analysis
Comments The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.
Method of Estimation Estimation Parameter Effect Size
Estimated Value 0.008
Confidence Interval (2-Sided) 99%
-0.23 to 0.24
Estimation Comments Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.
6.Primary Outcome
Title Changes in Everyday Speed of Processing From Baseline to Year 10
Hide Description 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.
Time Frame Up to 10 years
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Of the randomized subjects, 938 subjects who had the everyday speed of processing outcome at year 10 were used.
Arm/Group Title Memory Training Reasoning Training Speed of Processing Training Control
Hide Arm/Group Description:
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.
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.
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.
This group did not complete any cognitive training interventions
Overall Number of Participants Analyzed 229 249 245 215
Mean (Standard Deviation)
Unit of Measure: units on a scale
-1.53  (2.17) -1.39  (1.88) -1.47  (1.98) -1.42  (1.78)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Memory Training, Control
Comments Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.78
Comments [Not Specified]
Method Mixed Models Analysis
Comments The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.
Method of Estimation Estimation Parameter Effect Size
Estimated Value 0.02
Confidence Interval (2-Sided) 99%
-0.19 to 0.23
Estimation Comments Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Reasoning Training, Control
Comments Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.96
Comments [Not Specified]
Method Mixed Models Analysis
Comments The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.
Method of Estimation Estimation Parameter Effect Size
Estimated Value -0.004
Confidence Interval (2-Sided) 99%
-0.21 to 0.21
Estimation Comments Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Speed of Processing Training, Control
Comments Effect size was defined as training improvement from baseline to year 10 minus control improvement from baseline to year 10 divided by the intrasubject standard deviation (SD) of the composite score. Positive effect sizes indicate improvement.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.56
Comments [Not Specified]
Method Mixed Models Analysis
Comments The blom transformation was used to reduce skewness in the measures. The design factors and baseline covariates were controlled in the model.
Method of Estimation Estimation Parameter Effect Size
Estimated Value -0.05
Confidence Interval (2-Sided) 99%
-0.26 to 0.16
Estimation Comments Blom transformed outcome was used and the design factors and baseline covariates were controlled in the model to get the adjusted means. After that, the effect size (defined in the Additional details) was calculated using the adjusted means and SD.
7.Secondary Outcome
Title Changes in Health-related Quality of Life (HRQol), Driving Function, Health Service Use
Hide Description 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.
Time Frame 10th Year
Outcome Measure Data Not Reported
8.Secondary Outcome
Title Examine Health, Genetic and Cognitive Moderators
Hide Description 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.
Time Frame 10th Year
Outcome Measure Data Not Reported
9.Secondary Outcome
Title Estimate the Effects of ACTIVE Training to General Population
Hide Description 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.
Time Frame 10th Year
Outcome Measure Data Not Reported
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Memory Training Reasoning Training Speed of Processing Training Control
Hide Arm/Group Description 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. 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. 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. This group did not complete any cognitive training interventions
All-Cause Mortality
Memory Training Reasoning Training Speed of Processing Training Control
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Memory Training Reasoning Training Speed of Processing Training Control
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/711 (0.00%)   0/705 (0.00%)   0/712 (0.00%)   0/704 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Memory Training Reasoning Training Speed of Processing Training Control
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/711 (0.00%)   0/705 (0.00%)   0/712 (0.00%)   0/704 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period of 180 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo.
Results Point of Contact
Name/Title: Sharon L. Tennstedt, PhD
Organization: New England Research Institutes
Phone: 617-972-3362
Other Publications:
Responsible Party: New England Research Institutes
ClinicalTrials.gov Identifier: NCT00298558     History of Changes
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 Submitted: February 28, 2006
First Posted: March 2, 2006
Results First Submitted: April 24, 2013
Results First Posted: February 24, 2014
Last Update Posted: April 16, 2014