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Clinical Trials/NCT03602768
NCT03602768
Completed
Not Applicable

Evaluation of Online Cognitive Fitness Programs

Baycrest1 site in 1 country800 target enrollmentJune 18, 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Aging
Sponsor
Baycrest
Enrollment
800
Locations
1
Primary Endpoint
Change in memory strategy toolbox use
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

The current study is designed to test the effectiveness of online programs for memory and executive functions in healthy aging. The investigators are testing online adaptations of two cognitive interventions that have been extensively studied, validated, and implemented in clinical settings: The Memory & Aging Program (MAP) targets normal memory change in healthy aging, and Goal Management Training (GMT) targets executive functioning deficits in a variety of cognitive and neurological conditions including healthy aging. Both programs combine psycho-education, targeted skills training and clinical support to empower participants with knowledge and strategies to harness their cognitive faculties. These programs are being tested against a waitlist control as well as against a commercial/research brain training platform (Cambridge Brain Sciences) in a design comparing performance on memory and executive functioning measures before and after the interventions/controls. The main hypothesis is that MAP will lead to memory-specific improvements above control conditions, whereas GMT will lead to greater improvements in measures of executive functions relative to controls.

Registry
clinicaltrials.gov
Start Date
June 18, 2018
End Date
August 30, 2020
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Baycrest
Responsible Party
Principal Investigator
Principal Investigator

Brian Levine

Senior Scientist

Baycrest

Eligibility Criteria

Inclusion Criteria

  • Available to participate in all testing and intervention sessions and access to a computer
  • Computer familiarity
  • Cognitive complaint/concern/frustration

Exclusion Criteria

  • Health conditions with major effects on cognition, including a current or previous history of stroke, brain surgery, or diagnosed neurological disorder;
  • Dependence in instrumental activities of daily living
  • Cognitive impairment, defined as performance below cutoff for cognitive impairment on a standardized cognitive screening measure, the modified Telephone Interview for Cognitive Status (Welsh et al., 1993)
  • Affective impairment, defined as performance below cutoff for depression on standardized depression screen, the PHQ 2/9 (Yesavage et al., 1983)

Outcomes

Primary Outcomes

Change in memory strategy toolbox use

Time Frame: Pre-intervention; immediate post-intervention; 6 weeks following intervention completion.

Memory Strategy Toolbox quantifies application of strategies in memory-demanding everyday situations. It is scored from 0 - 6, with higher scores indicating increased ability to apply memory strategy toolbox.

Change in dysexecutive functioning

Time Frame: Pre-intervention; immediate post-intervention; 6 weeks following intervention completion.

Dysexecutive Functioning Index (DEX) questionnaire measures self-reported deficits in executive functions, and is composed of one scale with scores ranging from 0-80, where higher scores indicate greater executive deficit.

Change in cognitive failures

Time Frame: Pre-intervention; immediate post-intervention; 6 weeks following intervention completion.

Cognitive Failures Questionnaire (CFQ) measures self-reported failures in perception, memory, and motor function. It contains a single scale with scores ranging from 0-100, where higher scores indicate greater degree of impairment.

Change in memory knowledge score

Time Frame: Pre-intervention (post-randomization); immediate post-intervention; 6 weeks following intervention completion.

Memory Knowledge Quiz quantifies memory, lifestyle, and strategy knowledge. It is scored from 0-25, with higher scores indicating more knowledge about knowledge of lifestyle factors affecting memory and strategies to remember.

Change in Multifactorial Metamemory Questionnaire (MMQ)

Time Frame: Pre-intervention; immediate post-intervention; 6 weeks following intervention completion.

Quantifies subjective memory abilities, satisfaction, and strategy use. The MMQ contains 3 sub scales, but we are using total score as our outcome variable. MMQ total scores range from 0 - 228, with higher scores indicting high self-reported memory performance, satisfaction with it, and use of memory strategies.

Secondary Outcomes

  • Change in intentions to seek medical attention(Pre-intervention (post-randomization); immediate post-intervention; 6 weeks following intervention completion.)
  • Change in Impact of Memory Change on Daily Activities(Pre-intervention (post-randomization); immediate post-intervention; 6 weeks following intervention completion.)
  • Change in Cambridge Brain Sciences online cognitive assessment(Pre-intervention (post-randomization); immediate post-intervention; 6 weeks following intervention completion.)
  • Change in Patient-Specific Functional Scale(Pre-intervention (post-randomization); immediate post-intervention; 6 weeks following intervention completion.)
  • Change in associative memory(Pre-intervention (post-randomization); immediate post-intervention; 6 weeks following intervention completion.)

Study Sites (1)

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