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

Primary Purpose

Aging, Cognitive Decline

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Goal Management Training
Memory & Aging Program
Cambridge Brain Sciences
Sponsored by
Baycrest
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Aging focused on measuring Healthy aging, executive functions, memory, cognitive training, cognitive intervention, subjective cognitive impairment

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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)

Sites / Locations

  • Baycrest Health Sciences

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Placebo Comparator

No Intervention

Arm Label

Goal Management Training

Memory & Aging Program

Cambridge Brain Sciences Training

Waitlist

Arm Description

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.

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.

This is a commercial and research brain training platform, composed of 7 games that are online adaptations of the standard measures of cognition including working memory and spacial planning.

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.

Outcomes

Primary Outcome Measures

Change in dysexecutive functioning
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
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
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 memory strategy toolbox use
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 Multifactorial Metamemory Questionnaire (MMQ)
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

Change in Patient-Specific Functional Scale
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.
Change in Impact of Memory Change on Daily Activities
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.
Change in intentions to seek medical attention
Quantifies change in intentions to seek medical attention pertaining to memory concerns.
Change in Cambridge Brain Sciences online cognitive assessment
Battery of tasks that assess aspects of memory and reasoning.
Change in associative memory
Face-name task tests associative memory and sensitivity (d') will be measured as the outcome score.

Full Information

First Posted
July 12, 2018
Last Updated
July 23, 2021
Sponsor
Baycrest
Collaborators
Centre for Aging and Brain Health Innovation
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1. Study Identification

Unique Protocol Identification Number
NCT03602768
Brief Title
Evaluation of the Online Memory & Aging Program and Online Goal Management Training
Official Title
Evaluation of Online Cognitive Fitness Programs
Study Type
Interventional

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
June 18, 2018 (Actual)
Primary Completion Date
August 30, 2020 (Actual)
Study Completion Date
August 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baycrest
Collaborators
Centre for Aging and Brain Health Innovation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Aging, Cognitive Decline
Keywords
Healthy aging, executive functions, memory, cognitive training, cognitive intervention, subjective cognitive impairment

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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, Cambridge Brain Sciences brain training (active control), or waitlist. After intervention, the participants take the same test battery and complete it once more at 6 week followup.
Masking
ParticipantInvestigatorOutcomes 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.
Allocation
Randomized
Enrollment
800 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Goal Management Training
Arm Type
Experimental
Arm Description
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.
Arm Title
Memory & Aging Program
Arm Type
Experimental
Arm Description
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.
Arm Title
Cambridge Brain Sciences Training
Arm Type
Placebo Comparator
Arm Description
This is a commercial and research brain training platform, composed of 7 games that are online adaptations of the standard measures of cognition including working memory and spacial planning.
Arm Title
Waitlist
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Goal Management Training
Other Intervention Name(s)
GMT
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Memory & Aging Program
Other Intervention Name(s)
MAP
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cambridge Brain Sciences
Intervention Description
Commercial brain training software available for subscription to the general public and for research studies.
Primary Outcome Measure Information:
Title
Change in dysexecutive functioning
Description
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.
Time Frame
Pre-intervention; immediate post-intervention; 6 weeks following intervention completion.
Title
Change in cognitive failures
Description
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.
Time Frame
Pre-intervention; immediate post-intervention; 6 weeks following intervention completion.
Title
Change in memory knowledge score
Description
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.
Time Frame
Pre-intervention (post-randomization); immediate post-intervention; 6 weeks following intervention completion.
Title
Change in memory strategy toolbox use
Description
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.
Time Frame
Pre-intervention; immediate post-intervention; 6 weeks following intervention completion.
Title
Change in Multifactorial Metamemory Questionnaire (MMQ)
Description
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.
Time Frame
Pre-intervention; immediate post-intervention; 6 weeks following intervention completion.
Secondary Outcome Measure Information:
Title
Change in Patient-Specific Functional Scale
Description
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.
Time Frame
Pre-intervention (post-randomization); immediate post-intervention; 6 weeks following intervention completion.
Title
Change in Impact of Memory Change on Daily Activities
Description
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.
Time Frame
Pre-intervention (post-randomization); immediate post-intervention; 6 weeks following intervention completion.
Title
Change in intentions to seek medical attention
Description
Quantifies change in intentions to seek medical attention pertaining to memory concerns.
Time Frame
Pre-intervention (post-randomization); immediate post-intervention; 6 weeks following intervention completion.
Title
Change in Cambridge Brain Sciences online cognitive assessment
Description
Battery of tasks that assess aspects of memory and reasoning.
Time Frame
Pre-intervention (post-randomization); immediate post-intervention; 6 weeks following intervention completion.
Title
Change in associative memory
Description
Face-name task tests associative memory and sensitivity (d') will be measured as the outcome score.
Time Frame
Pre-intervention (post-randomization); immediate post-intervention; 6 weeks following intervention completion.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Levine, PhD
Organizational Affiliation
Rotman Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Baycrest Health Sciences
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M6A2E1
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
Brandt, J., Spencer, M., & Folstein, M. (1988). The Telephone Interview for Cognitive Status. Neuropsychiatry, Neuropsychology, & Behavioral Neurology, 1(2), 111-117.
Results Reference
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PubMed Identifier
7126941
Citation
Broadbent DE, Cooper PF, FitzGerald P, Parkes KR. The Cognitive Failures Questionnaire (CFQ) and its correlates. Br J Clin Psychol. 1982 Feb;21(1):1-16. doi: 10.1111/j.2044-8260.1982.tb01421.x.
Results Reference
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Citation
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.
Results Reference
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PubMed Identifier
23259956
Citation
Hampshire A, Highfield RR, Parkin BL, Owen AM. Fractionating human intelligence. Neuron. 2012 Dec 20;76(6):1225-37. doi: 10.1016/j.neuron.2012.06.022.
Results Reference
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PubMed Identifier
17166313
Citation
Levine B, Stuss DT, Winocur G, Binns MA, Fahy L, Mandic M, Bridges K, Robertson IH. Cognitive rehabilitation in the elderly: effects on strategic behavior in relation to goal management. J Int Neuropsychol Soc. 2007 Jan;13(1):143-52. doi: 10.1017/S1355617707070178.
Results Reference
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PubMed Identifier
10824502
Citation
Levine B, Robertson IH, Clare L, Carter G, Hong J, Wilson BA, Duncan J, Stuss DT. Rehabilitation of executive functioning: an experimental-clinical validation of goal management training. J Int Neuropsychol Soc. 2000 Mar;6(3):299-312. doi: 10.1017/s1355617700633052.
Results Reference
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PubMed Identifier
21369362
Citation
Levine B, Schweizer TA, O'Connor C, Turner G, Gillingham S, Stuss DT, Manly T, Robertson IH. Rehabilitation of executive functioning in patients with frontal lobe brain damage with goal management training. Front Hum Neurosci. 2011 Feb 17;5:9. doi: 10.3389/fnhum.2011.00009. eCollection 2011.
Results Reference
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Citation
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
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Citation
Troyer AK, Murphy KJ, Anderson ND, Moscovitch M, Craik FI. Changing everyday memory behaviour in amnestic mild cognitive impairment: a randomised controlled trial. Neuropsychol Rehabil. 2008 Jan;18(1):65-88. doi: 10.1080/09602010701409684.
Results Reference
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PubMed Identifier
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Citation
Troyer AK, Rich JB. Psychometric properties of a new metamemory questionnaire for older adults. J Gerontol B Psychol Sci Soc Sci. 2002 Jan;57(1):P19-27. doi: 10.1093/geronb/57.1.p19.
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Walker SN, Sechrist KR, Pender NJ. The Health-Promoting Lifestyle Profile: development and psychometric characteristics. Nurs Res. 1987 Mar-Apr;36(2):76-81.
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Evaluation of the Online Memory & Aging Program and Online Goal Management Training

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