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Evaluation of the Online Memory & Aging Program and Online Goal Management Training

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ClinicalTrials.gov Identifier: NCT03602768
Recruitment Status : Recruiting
First Posted : July 27, 2018
Last Update Posted : July 27, 2018
Sponsor:
Collaborator:
Centre for Aging and Brain Health Innovation
Information provided by (Responsible Party):
Brian Levine, Baycrest

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 brain training platform (BrainHQ) 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.

Condition or disease Intervention/treatment Phase
Aging Cognitive Decline Behavioral: Goal Management Training Behavioral: Memory & Aging Program Behavioral: BrainHQ Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants are screened, undergo a battery of cognitive testing for the pre-test, and then are randomly assigned to one of four intervention groups: MAP, GMT, BrainHQ (active control), or waitlist. After intervention, the participants take the same test battery and complete it once more at 6 week followup.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:

The study personnel who conduct screening and send pre/post-test surveys to participants are all blinded.

Randomizer is blinded to all participant pre-test outcomes. Care providers know what their participants are doing, but not aware of the full study design, including details of the other conditions or outcome test characteristics.

Primary Purpose: Prevention
Official Title: Evaluation of Online Cognitive Fitness Programs
Actual Study Start Date : June 18, 2018
Estimated Primary Completion Date : October 30, 2018
Estimated Study Completion Date : November 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory

Arm Intervention/treatment
Experimental: Goal Management Training
The online version of GMT with a therapist on the back-end monitoring progress and giving feedback throughout the program. Online GMT takes 5-9 weeks (self-paced) to complete 9 modules involving instructional video with interactive content, practice of cognitive strategies through games, and between-module exercises.
Behavioral: Goal Management Training
Pre-recorded videos and games combine psycho-education, targeted skills training, and mindfulness practice to teach a system where participants can take control of their attention and cognitive faculties.
Other Name: GMT

Experimental: Memory & Aging Program
The online version of MAP with a therapist moderator on the course discussion pages. MAP takes 5-9 weeks (self-paced) to complete 8 modules involving instructional video with interactive content and practice of memory strategies through various exercises.
Behavioral: Memory & Aging Program
Pre-recorded videos and activities combine psycho-education, memory strategy training, and social support to educate about normal memory change in aging, normalize the experience of participants going through it, and equip them to handle age-related memory change.
Other Name: MAP

Placebo Comparator: BrainHQ Training
This is a commercial brain training platform, with a course designed for memory and attention that can be completed at participants' own pace. Involves a number of short games that are advertised to train cognitive faculties.
Behavioral: BrainHQ
Commercial brain training software available for subscription to the general public.
Other Name: Posit Science

No Intervention: Waitlist
Participants randomized to this arm will receive no additional information or access to intervention programs until after the follow up testing measures are collected, at which point they will be given access to the intervention of their choosing.



Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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 Outcome Measures :
  1. Change in Patient-Specific Functional Scale [ Time Frame: Pre-intervention (post-randomization); immediate post-intervention; 6 weeks following intervention completion. ]
    Quantifies the impact of memory changes on daily activities and self-image. Is scored from 0 -10, with higher scores indicating greater ability to perform function, and taken as an average across number of activities scored.

  2. Change in Impact of Memory Change on Daily Activities [ Time Frame: Pre-intervention (post-randomization); immediate post-intervention; 6 weeks following intervention completion. ]
    Memory Impact Questionnaire (MIQ) quantifies the impact of memory changes on daily activities and self-image. The MIQ has three sub scales: Lifestyle Restriction, Positive Coping and Negative Emotion, and total score will be used as the outcome variable. Scores range from 0 - 204, with higher scores indicating greater impact of memory change on daily activities and self image.

  3. Change in intentions to seek medical attention [ Time Frame: Pre-intervention (post-randomization); immediate post-intervention; 6 weeks following intervention completion. ]
    Quantifies change in intentions to seek medical attention pertaining to memory concerns.

  4. Change in Cambridge Brain Sciences online cognitive assessment [ Time Frame: Pre-intervention (post-randomization); immediate post-intervention; 6 weeks following intervention completion. ]
    Battery of tasks that assess aspects of memory and reasoning.

  5. Change in associative memory [ Time Frame: Pre-intervention (post-randomization); immediate post-intervention; 6 weeks following intervention completion. ]
    Face-name task tests associative memory and sensitivity (d') will be measured as the outcome score.



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03602768


Contacts
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Contact: Brian Levine, PhD (416) 785-2500 ext 3593 blevine@research.baycrest.org
Contact: Angela K Troyer, PhD (416) 785-2500 atroyer@baycrest.org

Locations
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Canada, Ontario
Baycrest Health Sciences Recruiting
Toronto, Ontario, Canada, M6A2E1
Contact: Brian Levine, PhD    416-785-2500 ext 3593    blevine@research.baycrest.org   
Principal Investigator: Brian Levine, PhD         
Principal Investigator: Angela K Troyer, PhD         
Sponsors and Collaborators
Baycrest
Centre for Aging and Brain Health Innovation
Investigators
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Principal Investigator: Brian Levine, PhD Rotman Research Institute
  Study Documents (Full-Text)

Documents provided by Brian Levine, Baycrest:

Publications:
Brandt, J., Spencer, M., & Folstein, M. (1988). The Telephone Interview for Cognitive Status. Neuropsychiatry, Neuropsychology, & Behavioral Neurology, 1(2), 111-117.
Burgess, P. W., Alderman, N., Wilson, B. A., Evans, J. J., & Emslie, H. (1996). The dysexecutive questionnaire. Behavioural assessment of the dysexecutive syndrome. Bury St. Edmunds, UK: Thames Valley Test Company.
Troyer, A. K. (2001). Improving memory knowledge, satisfaction, and functioning via an education and intervention program for older adults. Aging, Neuropsychology, and Cognition, 8(4), 256-268
Welsh, K. A., Breitner, J.C.S., & Magruder-Habib, K.M. (1993) Detection of dementia in the elderly using telephone screening of cognitive status. Neuropsychiatry, Neuropsychology, and Behavioral Neurology, 6, 103-110.

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Responsible Party: Brian Levine, Senior Scientist, Baycrest
ClinicalTrials.gov Identifier: NCT03602768     History of Changes
Other Study ID Numbers: 17-24
First Posted: July 27, 2018    Key Record Dates
Last Update Posted: July 27, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Brian Levine, Baycrest:
Healthy aging
executive functions
memory
cognitive training
cognitive intervention
subjective cognitive impairment

Additional relevant MeSH terms:
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Cognitive Dysfunction
Cognition Disorders
Neurocognitive Disorders
Mental Disorders