Trial Outcomes & Findings for ACTIVE: Advanced Cognitive Training for Independent and Vital Elderly (NCT NCT00298558)

Last Updated: 2014-04-16

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2/PHASE3

Target enrollment

2832 participants

Primary outcome timeframe

Up to 10 years

Results posted on

2014-04-16

Participant Flow

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.

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.

Participant milestones

Participant milestones
Measure	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.	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.	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.	Control This group did not complete any cognitive training interventions
Baseline STARTED	711	705	712	704
Baseline COMPLETED	711	705	712	704
Baseline NOT COMPLETED	0	0	0	0
Intervention STARTED	711	705	712	704
Intervention COMPLETED	620	627	637	285
Intervention NOT COMPLETED	91	78	75	419
Immediate Post Test STARTED	711	705	712	704
Immediate Post Test COMPLETED	640	629	653	639
Immediate Post Test NOT COMPLETED	71	76	59	65
Booster STARTED	372	371	370	0
Booster COMPLETED	283	301	295	0
Booster NOT COMPLETED	89	70	75	0
1st Annual (A1) STARTED	640	629	653	639
1st Annual (A1) COMPLETED	585	566	601	584
1st Annual (A1) NOT COMPLETED	55	63	52	55
2nd Annual (A2) STARTED	585	566	601	584
2nd Annual (A2) COMPLETED	563	555	574	552
2nd Annual (A2) NOT COMPLETED	22	11	27	32
3rd Annual Booster STARTED	372	371	370	0
3rd Annual Booster COMPLETED	250	243	230	0
3rd Annual Booster NOT COMPLETED	122	128	140	0
3rd Annual (A3) and 5th Annual (A5) STARTED	563	555	574	552
3rd Annual (A3) and 5th Annual (A5) COMPLETED	472	469	490	448
3rd Annual (A3) and 5th Annual (A5) NOT COMPLETED	91	86	84	104
10th Annual (A10) STARTED	472	469	490	448
10th Annual (A10) COMPLETED	300	316	319	285
10th Annual (A10) NOT COMPLETED	172	153	171	163

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

ACTIVE: Advanced Cognitive Training for Independent and Vital Elderly

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Memory Training n=703 Participants 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 n=699 Participants 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 n=702 Participants 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.	Control n=698 Participants This group did not complete any cognitive training interventions	Total n=2802 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Age, Categorical >=65 years	703 Participants n=5 Participants	699 Participants n=7 Participants	702 Participants n=5 Participants	698 Participants n=4 Participants	2802 Participants n=21 Participants
Age, Continuous	73.5 years STANDARD_DEVIATION 6.02 • n=5 Participants	73.5 years STANDARD_DEVIATION 5.76 • n=7 Participants	73.4 years STANDARD_DEVIATION 5.78 • n=5 Participants	74.0 years STANDARD_DEVIATION 6.05 • n=4 Participants	73.6 years STANDARD_DEVIATION 5.91 • n=21 Participants
Sex: Female, Male Female	537 Participants n=5 Participants	537 Participants n=7 Participants	538 Participants n=5 Participants	514 Participants n=4 Participants	2126 Participants n=21 Participants
Sex: Female, Male Male	166 Participants n=5 Participants	162 Participants n=7 Participants	164 Participants n=5 Participants	184 Participants n=4 Participants	676 Participants n=21 Participants
Region of Enrollment United States	703 participants n=5 Participants	699 participants n=7 Participants	702 participants n=5 Participants	698 participants n=4 Participants	2802 participants n=21 Participants

PRIMARY outcome

Timeframe: Up to 10 years

Population: Of the randomized subjects, 943 subjects who had the memory outcome at year 10 were used.

Outcome measures

Outcome measures
Measure	Control n=216 Participants This group did not complete any cognitive training interventions	Memory Training n=231 Participants 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 n=248 Participants 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 n=248 Participants 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.
Changes in Cognitive Abilities of Memory From Baseline to Year 10	-9.4 units on a scale Standard Deviation 29.6	-10.6 units on a scale Standard Deviation 28.3	-11.2 units on a scale Standard Deviation 26.3	-12.7 units on a scale Standard Deviation 25.5

PRIMARY outcome

Timeframe: Up to 10 years

Population: Of the randomized subjects, 938 subjects who had the reasoning outcome at year 10 were used.

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.

Outcome measures

Outcome measures
Measure	Control n=214 Participants This group did not complete any cognitive training interventions	Memory Training n=230 Participants 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 n=246 Participants 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 n=248 Participants 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.
Changes in Cognitive Abilities of Reasoning From Baseline to Year 10	-3.04 units on a scale Standard Deviation 8.02	-3.23 units on a scale Standard Deviation 8.61	-0.049 units on a scale Standard Deviation 7.91	-3.94 units on a scale Standard Deviation 8.34

PRIMARY outcome

Timeframe: Up to 10 years

Population: Of the randomized subjects, 879 subjects who had the speed outcome at year 10 were used.

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.

Outcome measures

Outcome measures
Measure	Control n=203 Participants This group did not complete any cognitive training interventions	Memory Training n=216 Participants 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 n=231 Participants 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 n=229 Participants 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.
Changes in Cognitive Abilities of Speed of Processing From Baseline to Year 10	-123.3 units on a scale Standard Deviation 277.7	-144.4 units on a scale Standard Deviation 228.6	-126.2 units on a scale Standard Deviation 253.6	24.3 units on a scale Standard Deviation 252.1

PRIMARY outcome

Timeframe: Up to 10 years

Population: Of the randomized subjects, 1211 subjects who had the IADL outcome at year 10 were used.

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.

Outcome measures

Outcome measures
Measure	Control n=284 Participants This group did not complete any cognitive training interventions	Memory Training n=297 Participants 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 n=314 Participants 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 n=316 Participants 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.
Changes in Instrumental Activities of Daily Living (IADL) Difficulty From Baseline to Year 10	-3.61 units on a scale Standard Deviation 7.67	-3.05 units on a scale Standard Deviation 7.38	-2.66 units on a scale Standard Deviation 6.31	-2.34 units on a scale Standard Deviation 5.62

PRIMARY outcome

Timeframe: Up to 10 years

Population: Of the randomized subjects, 1104 subjects who had the everyday problem solving outcome at year 10 were used.

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.

Outcome measures

Outcome measures
Measure	Control n=249 Participants This group did not complete any cognitive training interventions	Memory Training n=270 Participants 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 n=290 Participants 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 n=295 Participants 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.
Changes in Everyday Problem Solving From Baseline to Year 10	-5.67 units on a scale Standard Deviation 9.85	-6.10 units on a scale Standard Deviation 9.75	-5.58 units on a scale Standard Deviation 9.56	-5.98 units on a scale Standard Deviation 9.32

PRIMARY outcome

Timeframe: Up to 10 years

Population: Of the randomized subjects, 938 subjects who had the everyday speed of processing outcome at year 10 were used.

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.

Outcome measures

Outcome measures
Measure	Control n=215 Participants This group did not complete any cognitive training interventions	Memory Training n=229 Participants 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 n=249 Participants 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 n=245 Participants 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.
Changes in Everyday Speed of Processing From Baseline to Year 10	-1.42 units on a scale Standard Deviation 1.78	-1.53 units on a scale Standard Deviation 2.17	-1.39 units on a scale Standard Deviation 1.88	-1.47 units on a scale Standard Deviation 1.98

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome data not reported

Adverse Events

Memory Training

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Reasoning Training

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Speed of Processing Training

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Sharon L. Tennstedt, PhD

New England Research Institutes

Phone: 617-972-3362

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee 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.
Publication restrictions are in place

Restriction type: OTHER