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ACTIVE: Advanced Cognitive Training for Independent and Vital Elderly

Sponsor
HealthCore-NERI (Other)
Overall Status
Completed
CT.gov ID
NCT00298558
Collaborator
National Institute on Aging (NIA) (NIH), National Institute of Nursing Research (NINR) (NIH)
2,832
Enrollment
7
Locations
4
Arms
153
Duration (Months)
404.6
Patients Per Site
2.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of the ACTIVE study was to test if cognitive training interventions could maintain functional independence in elders by improving basic mental abilities, with follow-up assessments through five years.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Cognitive Training
 Phase 2/Phase 3

Detailed Description

ACTIVE was a 4-arm, single-blind, randomized controlled trial. The primary objective of ACTIVE was to test the effectiveness and durability of three distinct cognitive interventions in improving elders' performance on basic measures of cognition and measures of cognitively demanding daily activities (e.g., food preparation, driving, medication use, financial management). These interventions previously had been found successful in improving cognitive abilities under laboratory or small-scale field conditions.

The three interventions shared common design features: 1) equivalent intensity and duration; 2) small group settings in ten 60-75 minute sessions; 3) focus on strategies for solving problems, remembering, or responding quickly to information; 4) modeling and demonstration of strategy usage; 5) practice on exemplar problems; 6) individual and group exercises; 7) feedback on performance; 8) fostering of self-efficacy regarding performance; 9) applying strategies to real-world tasks; 10) individualized training experiences, and 11) social interaction activities. In all three interventions, Sessions 1-5 focused on strategy instruction and exercises to practice the strategy. Sessions 6-10 provided additional practice exercises, but no new strategies were introduced. Content for each of the 10 sessions was scripted in a trainer's manual.

Interventions:

  1. Reasoning training focused on inductive reasoning, the ability to solve problems that follow a serial pattern and manifest in executive functioning. Participants were taught strategies to identify the pattern or sequence required to solve a problem. Training exercises involved identifying patterns in both laboratory-type reasoning tasks and in everyday activities, e.g., understanding the pattern in a bus schedule.

  2. Memory training focused on verbal episodic memory, which deals with acquisition and retrieval of information acquired in a particular place at a particular time. 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. Training exercises involved recalling laboratory-like episodic memory tasks as well as tasks related to everyday activities such as recalling a shopping list.

  3. Speed training focused on visual search and the ability to identify and locate visual information quickly in a divided attention format, with and without distractors. Participants practiced speeded tasks on a computer, and were allowed to proceed to more complex tasks, and faster and faster presentation speeds at their own pace.

  4. A control group received no training.

In addition, booster training was provided to help participants maintain gains made from initial training and to further improve cognitive skills. Booster training was provided to a random sample of approximately 50% of training participants at 11 and 35-36 months after primary training.

Participant involvement included assessments conducted at baseline, immediately post-intervention, and at 12, 24, 36 and 60 months. Assessments were conducted in individual and group sessions. For participants randomized to intervention groups, the interventions were conducted in small group settings in ten 60-75 minute sessions over a 5-6 week period. These were behavioral interventions with no pharmacologic component. Eleven months after the initial training was provided, booster training was offered, in all three intervention arms, to a randomly selected 60% of initially trained subjects. Booster training was delivered in four 75-minute sessions over a 2-3 week period.

The primary study hypotheses were:

  • Each training group will perform better than the other training and control groups on their respective primary and proximal outcomes

  • Those groups that received booster training will perform better than those that did not receive booster training on their respective primary and proximal outcomes.

Study Design

Study Type:
Interventional
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 :
Mar 1, 1998
Actual Primary Completion Date :
Dec 1, 2010
Actual Study Completion Date :
Dec 1, 2010

Arms and Interventions

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.

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.

Behavioral: Cognitive Training
Memory, Reasoning, or Speed of Processing cognitive training interventions
Placebo Comparator: Control

This group did not complete any cognitive training interventions

Behavioral: Cognitive Training
Memory, Reasoning, or Speed of Processing cognitive training interventions

Outcome Measures

Primary Outcome Measures

  1. Changes in Cognitive Abilities of Memory From Baseline to Year 10 [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.

  2. Changes in Cognitive Abilities of Reasoning From Baseline to Year 10 [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.

  3. Changes in Cognitive Abilities of Speed of Processing From Baseline to Year 10 [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.

  4. Changes in Instrumental Activities of Daily Living (IADL) Difficulty From Baseline to Year 10 [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.

  5. Changes in Everyday Problem Solving From Baseline to Year 10 [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.

  6. Changes in Everyday Speed of Processing From Baseline to Year 10 [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.

Secondary Outcome Measures

  1. Changes in Health-related Quality of Life (HRQol), Driving Function, Health Service Use [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.

  2. Examine Health, Genetic and Cognitive Moderators [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.

  3. Estimate the Effects of ACTIVE Training to General Population [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
65 Years and Older
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of Alabama at Birmingham Birmingham Alabama United States 35294
2 Indiana University Indianapolis Indiana United States 46202
3 Johns Hopkins University Baltimore Maryland United States 21205
4 Johns Hopkins University Cumberland Maryland United States 21205
5 Hebrew Rehabilitation Center for the Aged Boston Massachusetts United States 02131
6 Wayne State University Detroit Michigan United States 48202
7 Pennsylvania State University University Park Pennsylvania United States 16802

Sponsors and Collaborators

  • HealthCore-NERI
  • National Institute on Aging (NIA)
  • National Institute of Nursing Research (NINR)

Investigators

  • 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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
HealthCore-NERI
ClinicalTrials.gov Identifier:
NCT00298558
Other Study ID Numbers:
  • IA0091
  • U01NR004507
  • U01NR004508
  • U01AG014260
  • U01AG014282
  • U01AG014263
  • U01AG014289
  • U01AG014276
First Posted:
Mar 2, 2006
Last Update Posted:
Apr 16, 2014
Last Verified:
Jan 1, 2014
Keywords provided by HealthCore-NERI
cognition disorder
cognitive behavior therapy
functional ability

Study Results

Participant Flow

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 Detail 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
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: Baseline
STARTED 711 705 712 704
COMPLETED 620 627 637 285
NOT COMPLETED 91 78 75 419
Period Title: Baseline
STARTED 711 705 712 704
COMPLETED 640 629 653 639
NOT COMPLETED 71 76 59 65
Period Title: Baseline
STARTED 372 371 370 0
COMPLETED 283 301 295 0
NOT COMPLETED 89 70 75 0
Period Title: Baseline
STARTED 640 629 653 639
COMPLETED 585 566 601 584
NOT COMPLETED 55 63 52 55
Period Title: Baseline
STARTED 585 566 601 584
COMPLETED 563 555 574 552
NOT COMPLETED 22 11 27 32
Period Title: Baseline
STARTED 372 371 370 0
COMPLETED 250 243 230 0
NOT COMPLETED 122 128 140 0
Period Title: Baseline
STARTED 563 555 574 552
COMPLETED 472 469 490 448
NOT COMPLETED 91 86 84 104
Period Title: Baseline
STARTED 472 469 490 448
COMPLETED 300 316 319 285
NOT COMPLETED 172 153 171 163

Baseline Characteristics

Arm/Group Title Memory Training Reasoning Training Speed of Processing Training Control Total
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 Participants 703 699 702 698 2802
Age (Count of Participants)
<=18 years
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%
>=65 years
703
100%
699
100%
702
100%
698
100%
2802
100%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
73.5
(6.02)
73.5
(5.76)
73.4
(5.78)
74.0
(6.05)
73.6
(5.91)
Sex: Female, Male (Count of 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 (participants) [Number]
United States
703
100%
699
100%
702
100%
698
100%
2802
100%

Outcome Measures

1. Primary Outcome
Title Changes in Cognitive Abilities of Memory From Baseline to Year 10
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

Outcome Measure Data

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
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
Measure Participants 231 248 248 216
Mean (Standard Deviation) [units on a scale]
-10.6
(28.3)
-11.2
(26.3)
-12.7
(25.5)
-9.4
(29.6)
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
Statistical Test of Hypothesis p-Value 0.43
Comments
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
Parameter Dispersion Type:
Value:
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.
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
Statistical Test of Hypothesis p-Value 0.17
Comments
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
Parameter Dispersion Type:
Value:
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.
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
Statistical Test of Hypothesis p-Value 0.52
Comments
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
Parameter Dispersion Type:
Value:
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. Secondary Outcome
Title Changes in Health-related Quality of Life (HRQol), Driving Function, Health Service Use
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

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
3. Secondary Outcome
Title Examine Health, Genetic and Cognitive Moderators
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

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
4. Primary Outcome
Title Changes in Cognitive Abilities of Reasoning From Baseline to Year 10
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

Outcome Measure Data

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
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
Measure Participants 230 246 248 214
Mean (Standard Deviation) [units on a scale]
-3.23
(8.61)
-0.049
(7.91)
-3.94
(8.34)
-3.04
(8.02)
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
Statistical Test of Hypothesis p-Value 0.69
Comments
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
Parameter Dispersion Type:
Value:
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.
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
Statistical Test of Hypothesis p-Value <0.01
Comments
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
Parameter Dispersion Type:
Value:
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.
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
Statistical Test of Hypothesis p-Value 0.27
Comments
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
Parameter Dispersion Type:
Value:
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. Secondary Outcome
Title Estimate the Effects of ACTIVE Training to General Population
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

Analysis Population Description
[Not Specified]
Arm/Group Title
Arm/Group Description
6. Primary Outcome
Title Changes in Cognitive Abilities of Speed of Processing From Baseline to Year 10
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

Outcome Measure Data

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
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
Measure Participants 216 231 229 203
Mean (Standard Deviation) [units on a scale]
-144.4
(228.6)
-126.2
(253.6)
24.3
(252.1)
-123.3
(277.7)
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
Statistical Test of Hypothesis p-Value 0.45
Comments
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
Parameter Dispersion Type:
Value:
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.
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
Statistical Test of Hypothesis p-Value 0.95
Comments
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
Parameter Dispersion Type:
Value:
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.
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
Statistical Test of Hypothesis p-Value <0.01
Comments
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
Parameter Dispersion Type:
Value:
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. Primary Outcome
Title Changes in Instrumental Activities of Daily Living (IADL) Difficulty From Baseline to Year 10
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

Outcome Measure Data

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
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
Measure Participants 297 314 316 284
Mean (Standard Deviation) [units on a scale]
-3.05
(7.38)
-2.66
(6.31)
-2.34
(5.62)
-3.61
(7.67)
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
Statistical Test of Hypothesis p-Value <0.01
Comments
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
Parameter Dispersion Type:
Value:
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.
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
Statistical Test of Hypothesis p-Value <0.01
Comments
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
Parameter Dispersion Type:
Value:
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.
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
Statistical Test of Hypothesis p-Value <0.01
Comments
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
Parameter Dispersion Type:
Value:
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.
8. Primary Outcome
Title Changes in Everyday Problem Solving From Baseline to Year 10
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

Outcome Measure Data

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
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
Measure Participants 270 290 295 249
Mean (Standard Deviation) [units on a scale]
-6.10
(9.75)
-5.58
(9.56)
-5.98
(9.32)
-5.67
(9.85)
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
Statistical Test of Hypothesis p-Value 0.97
Comments
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
Parameter Dispersion Type:
Value:
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.
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
Statistical Test of Hypothesis p-Value 0.86
Comments
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
Parameter Dispersion Type:
Value:
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.
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
Statistical Test of Hypothesis p-Value 0.93
Comments
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
Parameter Dispersion Type:
Value:
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.
9. Primary Outcome
Title Changes in Everyday Speed of Processing From Baseline to Year 10
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

Outcome Measure Data

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
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
Measure Participants 229 249 245 215
Mean (Standard Deviation) [units on a scale]
-1.53
(2.17)
-1.39
(1.88)
-1.47
(1.98)
-1.42
(1.78)
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
Statistical Test of Hypothesis p-Value 0.78
Comments
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
Parameter Dispersion Type:
Value:
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.
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
Statistical Test of Hypothesis p-Value 0.96
Comments
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
Parameter Dispersion Type:
Value:
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.
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
Statistical Test of Hypothesis p-Value 0.56
Comments
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
Parameter Dispersion Type:
Value:
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.

Adverse Events

Time Frame
Adverse Event Reporting Description
Arm/Group Title Memory Training Reasoning Training Speed of Processing Training Control
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 (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total / (NaN) / (NaN) / (NaN) / (NaN)
Serious Adverse Events
Memory Training Reasoning Training Speed of Processing Training Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/711 (0%) 0/705 (0%) 0/712 (0%) 0/704 (0%)
Other (Not Including Serious) Adverse Events
Memory Training Reasoning Training Speed of Processing Training Control
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/711 (0%) 0/705 (0%) 0/712 (0%) 0/704 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

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
Email stennstedt@neriscience.com
Responsible Party:
HealthCore-NERI
ClinicalTrials.gov Identifier:
NCT00298558
Other Study ID Numbers:
  • IA0091
  • U01NR004507
  • U01NR004508
  • U01AG014260
  • U01AG014282
  • U01AG014263
  • U01AG014289
  • U01AG014276
First Posted:
Mar 2, 2006
Last Update Posted:
Apr 16, 2014
Last Verified:
Jan 1, 2014