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

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ClinicalTrials.gov Identifier: NCT00298558
Recruitment Status : Completed
First Posted : March 2, 2006
Results First Posted : February 24, 2014
Last Update Posted : April 16, 2014
Sponsor:
Collaborators:
National Institute on Aging (NIA)
National Institute of Nursing Research (NINR)
Information provided by (Responsible Party):
New England Research Institutes

Study Description
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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
Aging Healthy Behavioral: Cognitive Training Phase 2 Phase 3

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Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2832 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Trial of a Cognitive Intervention for Older Adults
Study Start Date : March 1998
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010
Arms and Interventions
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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
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Primary Outcome Measures :
  1. Changes in Cognitive Abilities of Memory From Baseline to Year 10 [ Time Frame: Up to 10 years ]
    Memory outcome was computed as the summation of Rey Auditory-Verbal Learning Test (AVLT), the Hopkins Verbal Learning Test (HVLT), and the Rivermead Behavioral Paragraph Recall test immediate recall. The possible range of the memory outcome is 0 to 132. Higher values represent a better outcome. Changes in outcome were computed as "10 year minus baseline" and the negative values indicate the decline from baseline.

  2. Changes in Cognitive Abilities of Reasoning From Baseline to Year 10 [ Time Frame: Up to 10 years ]
    Reasoning outcome was computed as the summation of total correct for Letter Series, Letter Sets, and Word Series. The possible range of the reasoning outcome is 0 to 75. Higher values represent a better outcome. Changes in outcome were computed as "10 year minus baseline" and the negative values indicate the decline from baseline.

  3. Changes in Cognitive Abilities of Speed of Processing From Baseline to Year 10 [ Time Frame: Up to 10 years ]
    Speed of processing outcome was computed as the summation of three Useful Field of View tasks requiring identification and localization of information, with 75% accuracy, under varying levels of cognitive demand. For the analysis, the reversed score was used and the possible range of the reversed speed of processing outcome is 0 to 1500. Higher values for the reversed scores represent a better outcome. Changes in outcome were computed as "10 year minus baseline" and the negative values indicate the decline from baseline.

  4. Changes in Instrumental Activities of Daily Living (IADL) Difficulty From Baseline to Year 10 [ Time Frame: Up to 10 years ]
    The self-reported measure of everyday IADL function was the summation of the IADL difficulty sub-scores from the Minimum Dataset - Home Care (MDS-HC) which assesses performance in the past 7 days on 19 daily tasks spanning meal preparation, housework, finances, health care, telephone, shopping, travel, and need for assistance in dressing, personal hygiene, and bathing. For the analysis, the reversed score was used and the possible range of the reversed everyday IADL function outcome is 0 to 38. Higher values for the reversed scores represent a better outcome. Changes in outcome were computed as "10 year minus baseline" and the negative values indicate the decline from baseline.

  5. Changes in Everyday Problem Solving From Baseline to Year 10 [ Time Frame: Up to 10 years ]
    Everyday Problem Solving was computed as the summation of the Everyday Problems Test (EPT) and Observed Tasks of Daily Living (OTDL). The possible range of the everyday problem solving outcome is 0 to 56. Higher values represent a better outcome. Changes in outcome were computed as "10 year minus baseline" and the negative values indicate the decline from baseline.

  6. Changes in Everyday Speed of Processing From Baseline to Year 10 [ Time Frame: Up to 10 years ]
    Everyday Speed of processing was computed as the summation of Complex Reaction Time (CRT) and Timed IADL (TIADL). For the analysis, the reversed score was used and the possible range of the reversed everyday speed of processing outcome is -3 to 100. Higher values for the reversed scores represent a better outcome. Changes in outcome were computed as "10 year minus baseline" and the negative values indicate the decline from baseline.


Secondary Outcome Measures :
  1. Changes in Health-related Quality of Life (HRQol), Driving Function, Health Service Use [ Time Frame: 10th Year ]
    To determine if the cognitive interventions have beneficial effects on the distal outcomes of driving safety, personal care activities of daily living, health service utilization, and mortality.

  2. Examine Health, Genetic and Cognitive Moderators [ Time Frame: 10th Year ]
    To examine heath, genetic, and cognitive moderators (including cardiovascular disease,diabetes, depression, Apolipoprotein E (APOE) genotype, and low cognition and engagement) in individual response to training.

  3. Estimate the Effects of ACTIVE Training to General Population [ Time Frame: 10th Year ]
    To estimate and project the effects of ACTIVE training to the general population of older adults by linking the measures and outcomes of ACTIVE to the Health and Retirement Study(and its subsidiary studies), a population-based, nationally-representative cohort.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   65 Years and older   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00298558


Locations
United States, Alabama
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35294
United States, Indiana
Indiana University
Indianapolis, Indiana, United States, 46202
United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21205
Johns Hopkins University
Cumberland, Maryland, United States, 21205
United States, Massachusetts
Hebrew Rehabilitation Center for the Aged
Boston, Massachusetts, United States, 02131
United States, Michigan
Wayne State University
Detroit, Michigan, United States, 48202
United States, Pennsylvania
Pennsylvania State University
University Park, Pennsylvania, United States, 16802
Sponsors and Collaborators
New England Research Institutes
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 New England Research Institutes
Principal Investigator: Michael Marsiske, PhD Wayne State University
Principal Investigator: Sherry Willis, PhD Penn State University
More Information
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Publications of Results:

Other Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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 Posted: March 2, 2006    Key Record Dates
Results First Posted: February 24, 2014
Last Update Posted: April 16, 2014
Last Verified: January 2014

Keywords provided by New England Research Institutes:
cognition disorder
cognitive behavior therapy
functional ability