Ignite Creation Date:
2025-12-25 @ 12:01 AM
Ignite Modification Date:
2025-12-25 @ 9:59 PM
Study NCT ID:
NCT00298558
Status:
COMPLETED
Last Update Posted:
2014-04-16
First Post:
2006-02-28
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
ACTIVE: Advanced Cognitive Training for Independent and Vital Elderly
Sponsor:
Carelon Research
Organization:
Study Overview
Official Title:
Trial of a Cognitive Intervention for Older Adults
Status:
COMPLETED
Status Verified Date:
2014-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ACTIVE
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| U01NR004507 | NIH | None | https://reporter.nih.gov/quic… | View |
| U01NR004508 | NIH | None | https://reporter.nih.gov/quic… | View |
| U01AG014260 | NIH | None | https://reporter.nih.gov/quic… | View |
| U01AG014282 | NIH | None | https://reporter.nih.gov/quic… | View |
| U01AG014263 | NIH | None | https://reporter.nih.gov/quic… | View |
| U01AG014289 | NIH | None | https://reporter.nih.gov/quic… | View |
| U01AG014276 | NIH | None | https://reporter.nih.gov/quic… | View |