- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06366867
An Open Platform of Serious Games for Cognitive Intervention
Computer games are increasingly utilized as tools for studying cognitive skills, aging, individual differences, and development. They offer a unique advantage by presenting challenges that more closely mirror the complexities and demands of everyday tasks compared to traditional laboratory experiments, clinical tests, and standardized assessments. Our team took an innovative step in this direction by developing a suite of tablet-based games, titled VibrantMinds. These games, varying in type, are designed to measure diverse cognitive indicators, acting as proxies for assessments typically conducted using paper-and-pencil tests in clinical settings.
VibrantMinds games have been specifically crafted to be user-friendly and engaging for older adults, including those with dementia. Our studies have shown that these individuals not only find the games accessible but also exhibit measurable improvement in gameplay, suggesting potential benefits for cognitive skill training.
Building on this foundation, we are now poised to conduct an in-depth investigation into the actual effectiveness of serious computer games (SCGs) for cognitive enhancement and their application in real-world settings for older adults. This next phase of research will leverage the VibrantMinds platform to carry out studies aimed at validating software-defined indicators of cognitive function and measuring the impact of game-based interventions on cognitive abilities, health-related quality of life, and other significant real-life outcomes.
The anticipated results promise to expand our understanding of the potential for new technologies in cognitive assessment and intervention. Moreover, by employing machine learning analysis of the data collected through VibrantMinds, we aim to develop a taxonomy that correlates game complexity and player performance with conventional clinical instruments for assessing cognitive status and functioning.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mathieu Figeys, PhD, RN
- Phone Number: 7804921728
- Email: figeys@ualberta.ca
Study Contact Backup
- Name: Adriana M Rios Rincon, PhD, R.OT
- Phone Number: 7804921728
- Email: aros@ualberta.ca
Study Locations
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Edmonton, Canada, T5J 3M9
- Recruiting
- CapitalCare Group Inc Facilities
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Contact:
- Adriana Rios Rincon, PhD, R.OT
- Phone Number: 7804921728
- Email: aros@ualberta.ca
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Older adults aged 65 years and older.
- Cognitive impairment within a specific range as measured by the Mini-Mental State -Examination (MMSE scores between 7 and 25).
- Ability to interact with the Serious Cognitive Games (SCGs) platform, indicating a necessary level of awareness.
- Functional vision and hearing, with or without aids (glasses/hearing aids), to engage with the SCGs platform.
- Functional upper extremity function to interact with the SCGs.
Exclusion Criteria:
- Presence of influenza, COVID-19, or another virus that could affect performance or pose a risk to others.
- Inability to communicate or comprehend instructions in English
- Moderate to severe limitations in upper extremity control or movement, significant visual or hearing impairments, or attention deficits that could impact the ability to successfully engage with the SCGs. Participants or their care partners who feel these conditions would interfere with study participation are excluded.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Device Feasibility
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: VibrantMinds + Standard Care
Older adults at long-term care facilities receive the VibrantMinds games in addition to routine standard care administered by the facility and staff.
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VibrantMindVibrantMinds offers five tablet games targeting cognitive stimulation in older adults: Whack-A-Mole, Word Search, Bejeweled, Mahjong Solitaire, Memory Game, and Glenrose Grocery Game (GGG).
These games vary from nostalgic (e.g., Mahjong Solitaire) to leisure-oriented (e.g., Bejeweled), aiming to blend fun with cognitive exercises.
Especially designed for ease of use, they cater to older individuals, including those with dementia, gradually increasing in difficulty to match player skill levels.
The GGG stands out by integrating game design with everyday cognitive tasks, offering a practical simulation of grocery shopping.
Developed with older adult input, VibrantMinds aims to enhance cognitive health in seniors through engaging, meaningful gameplay, supporting its clinical trial's focus on cognitive wellness in the aging.
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No Intervention: Standard Care
Older adults at long-term care facilities receive routine standard care administered by the facility and staff.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cognition - Global
Time Frame: Baseline (Week 0), Post-Test (Week 12), Follow-up (Week 16)
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Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADASCog).
Items are generally scored from 1-5; Final scores range 0-70, with higher scores indicating greater severity.
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Baseline (Week 0), Post-Test (Week 12), Follow-up (Week 16)
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Depression
Time Frame: Baseline (Week 0), Post-Test (Week 12), Follow-up (Week 16)
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Geriatric Depression Scale (GDS).
Each Item is scored 0/1 (no/yes respectively), for a total of 15 questions, and a maximum of 15 points.
Higher points indicate greater symptoms of depression.
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Baseline (Week 0), Post-Test (Week 12), Follow-up (Week 16)
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Agitation
Time Frame: Baseline (Week 0), Post-Test (Week 12), Follow-up (Week 16)
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Cohen-Mansfield Agitation Inventory (CMAI).
The CMAI is a 29 item scale, with each item ranging 1-7.
Higher scores indicate greater agitation
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Baseline (Week 0), Post-Test (Week 12), Follow-up (Week 16)
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Occupational Performance
Time Frame: Baseline (Week 0), Post-Test (Week 12), Follow-up (Week 16)
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The Canadian Occupational Performance Measure (COPM) employs a 1 to 10 scoring system, where clients rate their performance and satisfaction across chosen activities.
A score of 1 indicates poor performance or satisfaction, while a score of 10 signifies excellent outcomes.
Changes in these scores over time are used to evaluate the effectiveness of interventions based on client priorities.
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Baseline (Week 0), Post-Test (Week 12), Follow-up (Week 16)
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Engagement
Time Frame: At each session from weeks 0-12; average 2x per week.
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Engagement questionnaire.
A developed engagement questionnaire, with items ranked 1-5, will be utilized at each session
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At each session from weeks 0-12; average 2x per week.
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Affect
Time Frame: At each session from weeks 0-12; average 2x per week.
|
The Positive and Negative Affect Schedule (PANAS) consists of two 10-item mood scales, measuring both positive and negative affect.
Respondents rate each item on a scale from 1 (very slightly or not at all) to 5 (extremely), indicating the extent to which they have experienced each emotion.
Higher scores represent greater positive or negative affect, respectively.
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At each session from weeks 0-12; average 2x per week.
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Collaborators and Investigators
Sponsor
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Pro00097579
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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