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

Aging Clinical Trial

Official title:

Evaluation of Online Cognitive Fitness Programs

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03602768
• Other study ID #: 17-24
• Status: Completed
• Phase: N/A
• Start date: June 18, 2018
• Est. completion date: August 30, 2020

Study information

• Verified date: July 2021
• Source: Baycrest
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 800
• Est. completion date: August 30, 2020
• Est. primary completion date: August 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Aging
• Cognitive Decline
• Cognitive Dysfunction

Intervention

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.
• 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.
• Cambridge Brain Sciences
Commercial brain training software available for subscription to the general public and for research studies.

Locations

Country	Name	City	State
Canada	Baycrest Health Sciences	Toronto	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Baycrest	Centre for Aging and Brain Health Innovation

Country where clinical trial is conducted

Canada, 

References & Publications (13)

Brandt, J., Spencer, M., & Folstein, M. (1988). The Telephone Interview for Cognitive Status. Neuropsychiatry, Neuropsychology, & Behavioral Neurology, 1(2), 111-117.

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. — View 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.

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View 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

Walker SN, Sechrist KR, Pender NJ. The Health-Promoting Lifestyle Profile: development and psychometric characteristics. Nurs Res. 1987 Mar-Apr;36(2):76-81. — View Citation

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.

Wiegand MA, Troyer AK, Gojmerac C, Murphy KJ. Facilitating change in health-related behaviors and intentions: a randomized controlled trial of a multidimensional memory program for older adults. Aging Ment Health. 2013;17(7):806-15. doi: 10.1080/13607863.2013.789000. Epub 2013 Apr 23. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Pre-intervention; immediate post-intervention; 6 weeks following intervention completion.
Primary	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.	Pre-intervention; immediate post-intervention; 6 weeks following intervention completion.
Primary	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.	Pre-intervention (post-randomization); immediate post-intervention; 6 weeks following intervention completion.
Primary	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.	Pre-intervention; immediate post-intervention; 6 weeks following intervention completion.
Primary	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.	Pre-intervention; immediate post-intervention; 6 weeks following intervention completion.
Secondary	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.	Pre-intervention (post-randomization); immediate post-intervention; 6 weeks following intervention completion.
Secondary	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.	Pre-intervention (post-randomization); immediate post-intervention; 6 weeks following intervention completion.
Secondary	Change in intentions to seek medical attention	Quantifies change in intentions to seek medical attention pertaining to memory concerns.	Pre-intervention (post-randomization); immediate post-intervention; 6 weeks following intervention completion.
Secondary	Change in Cambridge Brain Sciences online cognitive assessment	Battery of tasks that assess aspects of memory and reasoning.	Pre-intervention (post-randomization); immediate post-intervention; 6 weeks following intervention completion.
Secondary	Change in associative memory	Face-name task tests associative memory and sensitivity (d') will be measured as the outcome score.	Pre-intervention (post-randomization); immediate post-intervention; 6 weeks following intervention completion.