GAMES Intervention in MCI (Mild Cognitive Impairment)

Emory University

Status: Enrolling

Conditions: Mild Cognitive Impairment

Treatments: Behavioral: Waitlist control; Behavioral: Online Gameplay Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT07296133

1R44AG078009-01 (U.S. NIH Grant/Contract)

2025P011653

Details and patient eligibility

About

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).

Full 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.

Enrollment: 124 estimated patients

Sex: All

Ages: 50 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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124 participants in 2 patient groups

Online Gameplay Intervention Group

Experimental group

Description:

Participants will receive: * brief (\< 10 minutes) psychoeducation about the importance of engaging in social activities to support cognitive stimulation and brain health * technology session to show them how to access games via OneClick * participants will receive weekly calls from study staff to provide support and briefly query about social activities that week. * A subset of questionnaires will be re-administered after 6 weeks of the intervention to capture any change occurring at intervention mid-point. * Following completion of the 12-week intervention, participants will repeat a subset of baseline questionnaires to evaluate for change over time.

Treatment:

Behavioral: Online Gameplay Intervention

Wait-list control Group

Other group

Description:

Participants will receive: * brief (\< 10 minutes) psychoeducation about the importance of engaging in social activities to support cognitive stimulation and brain health * Participants will be notified that study team will receive weekly phone calls to ask about social activities they completed in the week prior. * Following completion of the 12-week waitlist period, participants will repeat the baseline questionnaires to evaluate for change over time. * After completing the waitlist condition, they will be offered the opportunity to complete the gameplay intervention.

Treatment:

Behavioral: Waitlist control