NCT07541144

Brief Summary

The study examines the effects of a group digital gaming intervention on cognitive function, mood, and behaviors in people with early to moderate levels of dementia, using Obie Technology by employing a pretest and posttest design with a mixed methods approach.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2023

Shorter than P25 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2024

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

April 14, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 21, 2026

Completed
Last Updated

April 21, 2026

Status Verified

April 1, 2026

Enrollment Period

9 months

First QC Date

April 14, 2026

Last Update Submit

April 14, 2026

Conditions

Dementia

Outcome Measures

Primary Outcomes (2)

  • Montreal Cognitive Assessment (MoCA):

    Before the intervention (baseline), at the end of week 10, and at the end of the intervention (after 20 weeks of the study).

  • Neuropsychiatric Inventory Questionnaire (NPI-Q)

    Before the intervention (baseline), at the end of week 10, and at the end of the intervention (after 20 weeks of the study).

Study Arms (1)

Group-Based Digital Gaming

EXPERIMENTAL
Behavioral: Group-Based Digital Gaming

Interventions

Group-Based Digital GamingBEHAVIORAL

The interactive digital gaming activity is delivered using Obie Technology. Various games are projected onto the table's surface, and participants interacted with them by "touching" the images with their hands. The system included sensors that detected hand movements, making the activity fully interactive. More than 200 games are available. Some examples of the popular games include Mahjong, in which participants match identical tiles by touching them, and Around the World, in which participants identify the correct objects based on the country's flag, such as selecting a double-decker London bus for the United Kingdom. For many games, difficulty levels are adjustable, which is especially useful for games that involves math. Games are chosen based on participants' requests as well as facilitators' recommendations.

Group-Based Digital Gaming

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

George Mason University

Fairfax, Virginia, 22030, United States

Location

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 14, 2026

First Posted

April 21, 2026

Study Start

August 1, 2023

Primary Completion

April 30, 2024

Study Completion

April 30, 2024

Last Updated

April 21, 2026

Record last verified: 2026-04

Locations

US(1)