NCT06366867

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 3, 2022

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

April 4, 2024

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 16, 2024

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

May 12, 2026

Status Verified

May 1, 2026

Enrollment Period

3.5 years

First QC Date

April 4, 2024

Last Update Submit

May 7, 2026

Conditions

Keywords

Serious computer gamecomputer gamesVibrantMinds

Outcome Measures

Primary Outcomes (1)

  • Cognition - Global

    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.

    Baseline (Week 0), Post-Test (Week 12), Follow-up (Week 16)

Secondary Outcomes (5)

  • Depression

    Baseline (Week 0), Post-Test (Week 12), Follow-up (Week 16)

  • Agitation

    Baseline (Week 0), Post-Test (Week 12), Follow-up (Week 16)

  • Occupational Performance

    Baseline (Week 0), Post-Test (Week 12), Follow-up (Week 16)

  • Engagement

    At each session from weeks 0-12; average 2x per week.

  • Affect

    At each session from weeks 0-12; average 2x per week.

Study Arms (2)

VibrantMinds + Standard Care

EXPERIMENTAL

Older adults at long-term care facilities receive the VibrantMinds games in addition to routine standard care administered by the facility and staff.

Device: VibrantMinds

Standard Care

NO INTERVENTION

Older adults at long-term care facilities receive routine standard care administered by the facility and staff.

Interventions

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.

VibrantMinds + Standard Care

Eligibility Criteria

Age65 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CapitalCare Group Inc Facilities

Edmonton, T5J 3M9, Canada

Location

Related Links

MeSH Terms

Conditions

Cognitive DysfunctionDementiaAlzheimer Disease

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesTauopathiesNeurodegenerative Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Random allocation, 1:1 ratio by a computer-based randomizer
Purpose
DEVICE FEASIBILITY
Intervention Model
PARALLEL
Model Details: The experimental group will receive VibrantMinds, which consists of sessions with serious computer games in addition to the standard care, whilst the control group will receive the standard of care used at the healthcare facilities.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2024

First Posted

April 16, 2024

Study Start

August 3, 2022

Primary Completion

February 1, 2026

Study Completion

February 1, 2026

Last Updated

May 12, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations