ACTIVE: Advanced Cognitive Training for Independent and Vital Elderly

Phase 2

Completed

Conditions: Healthy
Aging

Interventions: Behavioral: Cognitive Training

Registration Number: NCT00298558

Lead Sponsor: Carelon Research

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.

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 2832

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Reasoning Training	Cognitive 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.
Memory Training	Cognitive 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.
Speed of Processing Training	Cognitive 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	Cognitive Training	This group did not complete any cognitive training interventions

Primary Outcome Measures

Name	Time	Method
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.
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.
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.
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.
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.
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.

Secondary Outcome Measures

Name	Time	Method
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.
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.
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.

Trial Locations

Locations (6): University of Alabama at Birmingham
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Birmingham, Alabama, United States
Indiana University
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Indianapolis, Indiana, United States
Wayne State University
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Detroit, Michigan, United States
Hebrew Rehabilitation Center for the Aged
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Boston, Massachusetts, United States
Johns Hopkins University
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Cumberland, Maryland, United States
Pennsylvania State University
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University Park, Pennsylvania, United States