Clinical trial NCT06366867: An Open Platform of Serious Games for Cognitive Intervention
Official title: An Open Platform of Serious Games for Cognitive Intervention
Study type: INTERVENTIONAL
Overall status: SUSPENDED
Phase: NA
Conditions: Mild Cognitive Impairment
Dementia
Alzheimer Disease
Aging
Keywords: Serious computer game
computer games
VibrantMinds
Lead sponsor: University of Alberta
Sponsor class: OTHER
Collaborators: name: Alberta Health services
name: CapitalCare
First posted: 2024-04-16
Enrollment: 122
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: DEVICE_FEASIBILITY

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Cognition - Global
timeFrame: Baseline (Week 0), Post-Test (Week 12), Follow-up (Week 16)
Secondary outcomes:
measure: Depression
timeFrame: Baseline (Week 0), Post-Test (Week 12), Follow-up (Week 16)
measure: Agitation
timeFrame: Baseline (Week 0), Post-Test (Week 12), Follow-up (Week 16)
measure: Occupational Performance
timeFrame: Baseline (Week 0), Post-Test (Week 12), Follow-up (Week 16)
measure: Engagement
timeFrame: At each session from weeks 0-12; average 2x per week.
measure: Affect
timeFrame: At each session from weeks 0-12; average 2x per week.
Other outcomes:
Locations:
city: Edmonton
country: Canada
facility: CapitalCare Group Inc Facilities
Study officials:
References: