GAMES Intervention in MCI (Mild Cognitive Impairment)

NCT ID: NCT07296133

Last Updated: 2025-12-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

124 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-08

Study Completion Date

2027-03-31

Brief Summary

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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

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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.

Conditions

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Mild Cognitive Impairment

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Online Gameplay Intervention Group

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.

Group Type EXPERIMENTAL

Online Gameplay Intervention

Intervention Type BEHAVIORAL

-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 that week.
* They will not receive reminders or be contacted by the study outside of the weekly phone calls, apart from mid intervention questionnaires.

Wait-list control Group

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.

Group Type OTHER

Waitlist control

Intervention Type BEHAVIORAL

\- 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.

Interventions

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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 that week.
* They will not receive reminders or be contacted by the study outside of the weekly phone calls, apart from mid intervention questionnaires.

Intervention Type 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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute on Aging (NIA)

NIH

Sponsor Role collaborator

Emory University

OTHER

Sponsor Role lead

Responsible Party

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Kayci Vickers

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kayci Vickers, PhD

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

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Emory University

Atlanta, Georgia, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Kayci Vickers, PhD

Role: CONTACT

Phone: (404) 712-4849

Email: [email protected]

Other Identifiers

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1R44AG078009-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2025P011653

Identifier Type: -

Identifier Source: org_study_id