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
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
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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
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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  
Number of Participants  
[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
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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
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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
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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:
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