Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Sponsor:
Collaborators:
National Institute on Aging (NIA)
National Institute of Nursing Research (NINR)
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
Results First Received: April 24, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Subject);   Primary Purpose: Prevention
Conditions: Aging
Healthy
Intervention: Behavioral: Cognitive Training

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment occurred from March 1998 through October 1999 at six metropolitan field centers: University of Alabama at Birmingham, Boston Hebrew Rehabilitation Center for Aged (now Hebrew Senior Life), Indiana University School of Medicine, Johns Hopkins University, Pennsylvania State University, and Wayne State University.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Eligibility and demographics were gathered at telephone screening.Health history, physical status, functional status, mental status, cognitive and function measures were gathered via in-person exams in individual and small-group formats at baseline.Eligible subjects were randomly assigned to one of three interventions or no-contact control group.

Reporting Groups
  Description
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.
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.
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.
Control This group did not complete any cognitive training interventions

Participant Flow for 9 periods

Period 1:   Baseline
    Memory Training   Reasoning Training   Speed of Processing Training   Control
STARTED   711   705   712   704 
COMPLETED   711   705   712   704 
NOT COMPLETED   0   0   0   0 

Period 2:   Intervention
    Memory Training   Reasoning Training   Speed of Processing Training   Control
STARTED   711   705   712   704 
COMPLETED   620   627   637   285 
NOT COMPLETED   91   78   75   419 

Period 3:   Immediate Post Test
    Memory Training   Reasoning Training   Speed of Processing Training   Control
STARTED   711   705   712   704 
COMPLETED   640   629   653   639 
NOT COMPLETED   71   76   59   65 

Period 4:   Booster
    Memory Training   Reasoning Training   Speed of Processing Training   Control
STARTED   372   371   370   0 
COMPLETED   283   301   295   0 
NOT COMPLETED   89   70   75   0 

Period 5:   1st Annual (A1)
    Memory Training   Reasoning Training   Speed of Processing Training   Control
STARTED   640   629   653   639 
COMPLETED   585   566   601   584 
NOT COMPLETED   55   63   52   55 

Period 6:   2nd Annual (A2)
    Memory Training   Reasoning Training   Speed of Processing Training   Control
STARTED   585   566   601   584 
COMPLETED   563   555   574   552 
NOT COMPLETED   22   11   27   32 

Period 7:   3rd Annual Booster
    Memory Training   Reasoning Training   Speed of Processing Training   Control
STARTED   372   371   370   0 
COMPLETED   250   243   230   0 
NOT COMPLETED   122   128   140   0 

Period 8:   3rd Annual (A3) and 5th Annual (A5)
    Memory Training   Reasoning Training   Speed of Processing Training   Control
STARTED   563   555   574   552 
COMPLETED   472   469   490   448 
NOT COMPLETED   91   86   84   104 

Period 9:   10th Annual (A10)
    Memory Training   Reasoning Training   Speed of Processing Training   Control
STARTED   472   469   490   448 
COMPLETED   300   316   319   285 
NOT COMPLETED   172   153   171   163 



  Baseline Characteristics
  Hide Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Of 2832 randomized subjects, 30 subjects were randomized inappropriately in violation of the protocol and excluded from the analysis. Therefore, 2802 subjects were used for the baseline analysis.

Reporting Groups
  Description
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.
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.
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.
Control This group did not complete any cognitive training interventions
Total Total of all reporting groups

Baseline Measures
   Memory Training   Reasoning Training   Speed of Processing Training   Control   Total 
Overall Participants Analyzed 
[Units: Participants]
 703   699   702   698   2802 
Age 
[Units: Participants]
         
<=18 years   0   0   0   0   0 
Between 18 and 65 years   0   0   0   0   0 
>=65 years   703   699   702   698   2802 
Age 
[Units: Years]
Mean (Standard Deviation)
 73.5  (6.02)   73.5  (5.76)   73.4  (5.78)   74.0  (6.05)   73.6  (5.91) 
Gender 
[Units: Participants]
         
Female   537   537   538   514   2126 
Male   166   162   164   184   676 
Region of Enrollment 
[Units: Participants]
         
United States   703   699   702   698   2802 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Changes in Cognitive Abilities of Memory From Baseline to Year 10   [ Time Frame: Up to 10 years ]

2.  Primary:   Changes in Cognitive Abilities of Reasoning From Baseline to Year 10   [ Time Frame: Up to 10 years ]

3.  Primary:   Changes in Cognitive Abilities of Speed of Processing From Baseline to Year 10   [ Time Frame: Up to 10 years ]

4.  Primary:   Changes in Instrumental Activities of Daily Living (IADL) Difficulty From Baseline to Year 10   [ Time Frame: Up to 10 years ]

5.  Primary:   Changes in Everyday Problem Solving From Baseline to Year 10   [ Time Frame: Up to 10 years ]

6.  Primary:   Changes in Everyday Speed of Processing From Baseline to Year 10   [ Time Frame: Up to 10 years ]

7.  Secondary:   Changes in Health-related Quality of Life (HRQol), Driving Function, Health Service Use   [ Time Frame: 10th Year ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

8.  Secondary:   Examine Health, Genetic and Cognitive Moderators   [ Time Frame: 10th Year ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No

9.  Secondary:   Estimate the Effects of ACTIVE Training to General Population   [ Time Frame: 10th Year ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
  Hide More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Sharon L. Tennstedt, PhD
Organization: New England Research Institutes
phone: 617-972-3362
e-mail: stennstedt@neriscience.com


Publications of Results:
Other Publications:


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