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ACTIVE: Advanced Cognitive Training for Independent and Vital Elderly

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
New England Research Institutes
ClinicalTrials.gov Identifier:
NCT00298558
First received: February 28, 2006
Last updated: March 24, 2014
Last verified: January 2014
  Purpose

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 Intervention Phase
Aging
Healthy
Behavioral: Cognitive Training
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Prevention
Official Title: Trial of a Cognitive Intervention for Older Adults

Resource links provided by NLM:


Further study details as provided by New England Research Institutes:

Primary Outcome Measures:
  • Changes in Cognitive Abilities of Memory From Baseline to Year 10 [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
    Memory outcome was computed as the summation of Rey Auditory-Verbal Learning Test (AVLT), the Hopkins Verbal Learning Test (HVLT), and the Rivermead Behavioral Paragraph Recall test immediate recall. The possible range of the memory outcome is 0 to 132. Higher values represent a better outcome. Changes in outcome were computed as "10 year minus baseline" and the negative values indicate the decline from baseline.

  • Changes in Cognitive Abilities of Reasoning From Baseline to Year 10 [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
    Reasoning outcome was computed as the summation of total correct for Letter Series, Letter Sets, and Word Series. The possible range of the reasoning outcome is 0 to 75. Higher values represent a better outcome. Changes in outcome were computed as "10 year minus baseline" and the negative values indicate the decline from baseline.

  • Changes in Cognitive Abilities of Speed of Processing From Baseline to Year 10 [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
    Speed of processing outcome was computed as the summation of three Useful Field of View tasks requiring identification and localization of information, with 75% accuracy, under varying levels of cognitive demand. For the analysis, the reversed score was used and the possible range of the reversed speed of processing outcome is 0 to 1500. Higher values for the reversed scores represent a better outcome. Changes in outcome were computed as "10 year minus baseline" and the negative values indicate the decline from baseline.

  • Changes in Instrumental Activities of Daily Living (IADL) Difficulty From Baseline to Year 10 [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
    The self-reported measure of everyday IADL function was the summation of the IADL difficulty sub-scores from the Minimum Dataset - Home Care (MDS-HC) which assesses performance in the past 7 days on 19 daily tasks spanning meal preparation, housework, finances, health care, telephone, shopping, travel, and need for assistance in dressing, personal hygiene, and bathing. For the analysis, the reversed score was used and the possible range of the reversed everyday IADL function outcome is 0 to 38. Higher values for the reversed scores represent a better outcome. Changes in outcome were computed as "10 year minus baseline" and the negative values indicate the decline from baseline.

  • Changes in Everyday Problem Solving From Baseline to Year 10 [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
    Everyday Problem Solving was computed as the summation of the Everyday Problems Test (EPT) and Observed Tasks of Daily Living (OTDL). The possible range of the everyday problem solving outcome is 0 to 56. Higher values represent a better outcome. Changes in outcome were computed as "10 year minus baseline" and the negative values indicate the decline from baseline.

  • Changes in Everyday Speed of Processing From Baseline to Year 10 [ Time Frame: Up to 10 years ] [ Designated as safety issue: No ]
    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:
  • Changes in Health-related Quality of Life (HRQol), Driving Function, Health Service Use [ Time Frame: 10th Year ] [ Designated as safety issue: No ]
    To determine if the cognitive interventions have beneficial effects on the distal outcomes of driving safety, personal care activities of daily living, health service utilization, and mortality.

  • Examine Health, Genetic and Cognitive Moderators [ Time Frame: 10th Year ] [ Designated as safety issue: No ]
    To examine heath, genetic, and cognitive moderators (including cardiovascular disease,diabetes, depression, Apolipoprotein E (APOE) genotype, and low cognition and engagement) in individual response to training.

  • Estimate the Effects of ACTIVE Training to General Population [ Time Frame: 10th Year ] [ Designated as safety issue: No ]
    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.


Enrollment: 2832
Study Start Date: March 1998
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Hide Detailed Description

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.
  Eligibility

Ages Eligible for Study:   65 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
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

Publications:
Diehl M, Marsiske M, Horgas A, Rosenberg A, Saczynski J, and Willis S. The revised observed tasks of daily living: A performance-based assessment of everyday problem solving. Journal of Applied Gerontology 2005 24(3): 211-230.

Responsible Party: New England Research Institutes
ClinicalTrials.gov Identifier: NCT00298558     History of Changes
Other Study ID Numbers: IA0091, U01NR004507, U01NR004508, U01AG014260, U01AG014282, U01AG014263, U01AG014289, U01AG014276
Study First Received: February 28, 2006
Results First Received: April 24, 2013
Last Updated: March 24, 2014
Health Authority: United States: Federal Government

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

ClinicalTrials.gov processed this record on November 20, 2014