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

March 24, 2014 updated by: HealthCore-NERI

Trial of a Cognitive Intervention for Older Adults

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

2832

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University
    • Maryland
      • Baltimore, Maryland, United States, 21205
        • Johns Hopkins University
      • Cumberland, Maryland, United States, 21205
        • Johns Hopkins University
    • Massachusetts
      • Boston, Massachusetts, United States, 02131
        • Hebrew Rehabilitation Center for the Aged
    • Michigan
      • Detroit, Michigan, United States, 48202
        • Wayne State University
    • Pennsylvania
      • University Park, Pennsylvania, United States, 16802
        • Pennsylvania State University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

61 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to 10 years
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.
Up to 10 years
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.
Up to 10 years
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.
Up to 10 years
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.
Up to 10 years
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.
Up to 10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
10th Year
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.
10th Year
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.
10th Year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HealthCore-NERI

Collaborators

National Institute of Nursing Research (NINR)
National Institute on Aging (NIA)

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 1998

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

February 28, 2006

First Submitted That Met QC Criteria

February 28, 2006

First Posted (Estimate)

March 2, 2006

Study Record Updates

Last Update Posted (Estimate)

April 16, 2014

Last Update Submitted That Met QC Criteria

March 24, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

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)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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