GAMES Intervention in MCI (Mild Cognitive Impairment)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Online Gameplay Intervention, Waitlist control.
- Who it may be relevant to
- Registry conditions: Mild Cognitive Impairment. Basic parameters: 50 years — 85 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Evaluating Online Gameplay Intervention to Support Social Engagement in Older Adults With and Without Mild Cognitive Impairment (MCI)
Overview
The objective of the present study is to evaluate whether online, remote gameplay can facilitate social engagement and reduce feelings of loneliness and isolation in adults with and without mild cognitive impairment (MCI).
Detailed description
In this study, the investigators will complete a low burden gameplay intervention wherein individuals with and without MCI will be asked to play specially created online versions of common games (such as Connect 4 and Uno) 3 times per week for 12 weeks. Each gameplay session will last at least 15 minutes. Individuals in the intervention condition will begin gameplay immediately, those in the waitlist control condition will complete a 12-week waiting period before beginning gameplay. All games will be delivered via a novel online platform (OneClick; developed by PotLuck, LLC) created specifically to support and enhance social engagement with family members and close friends. In addition to weekly gameplay, participants will receive weekly calls from study staff, both during the waitlist and intervention conditions, to provide support and briefly query about social activities that week. They will also complete a series of questionnaires at 0-, 6-, and 12-weeks of the intervention to evaluate outcomes. The long-term goal of this research is to benefit health and quality-of-life outcomes by delivering remote socialization options to older adults with MCI. OneClick is an easy-to-use platform that has been designed with and for older adults, including those with MCI, to accommodate their unique socialization needs and technology design requirements. The OneClick platform and games used in this study are owned by PotLuck, LLC and therefore stand to be commercialized by their team. Data will not be submitted to the FDA and procedures will not be tested clinically as part of this protocol. In this phase of the study, we will test whether online games delivered via the OneClick platform improve research participants' report of social engagement, isolation, and loneliness alongside other aspects of wellbeing.
Interventions
- Behavioral Online Gameplay Intervention
-The online gameplay intervention includes playing online versions of common games (such as Connect 4 and Uno) with a partner, 3 times per week for at least 15 minutes, for 12 weeks. All games will be delivered via a novel online platform (OneClick; developed by PotLuck, LLC) created specifically to support and enhance social engagement with family members and close friends. * Participants will receive weekly calls from study staff to provide support and briefly query about social activities t - Behavioral Waitlist control
\- Participants will be informed that study team will contact them once per week by telephone for 12 weeks, to ask about social activities they completed in the week prior.
Primary outcome measures
- Change in friendship Scale score [Time frame: Pre-intervention (Baseline), week 6 and post-intervention (week 12)]
- Change in UCLA Loneliness Scale score [Time frame: Pre-intervention (Baseline), week 6 and post-intervention (week 12)]
- Change in Neuro-QOL score [Time frame: Pre-intervention (Baseline), week 6 and post-intervention (week 12)]
- Change in meaning and purpose score [Time frame: Pre-intervention (Baseline), week 6 and post-intervention (week 12)]
Secondary outcome measures (2)
- Change in Tech Experience and Comfort scale score [Time frame: Pre-intervention (Baseline), week 6 and post-intervention (week 12)]
- Change in Perceived Stress score [Time frame: Pre-intervention (Baseline), week 6 and post-intervention (week 12)]
Eligibility criteria
Inclusion criteria
- 50 to 85 years old
- Living independently (note: can live in assisted living, but must have independently complete daily activities)
- Fluent in English
- Adequate visual and auditory acuity to see/hear computer screen
- MoCA-Blind (converted to MoCA score) > 17
Additional Criteria for MCI Group:
- Existing diagnosis by HC professional
- MoCA-Blind (converted to MoCA score) of 18-25
- FAQ < 9
Exclusion criteria
- Cognitive impairment secondary to stroke, TBI or other neurological cause without concern for neurodegenerative condition (e.g., Alzheimer's disease, vascular dementia, etc.)
- Medical illnesses that would prevent participation
- Major psychiatric disturbance meeting DSM V criteria in last year
- Hx of substance abuse within last two years
- Current psychoactive med use
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 1 center
- Emory University — Atlanta
Identifiers
NCT: NCT07296133 · 2025P011653 · 1R44AG078009-01