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NCT Number: NCT07296133

GAMES Intervention in MCI (Mild Cognitive Impairment)

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).

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Key information

Conditions

Mild Cognitive Impairment Cognition Disorders Cognitive Dysfunction Mental Disorders Neurocognitive Disorders

Age range

50 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Emory University

Atlanta, Georgia, 30322, United States

Location status: Recruiting

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Online Gameplay Intervention

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.

Waitlist Control

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.

Primary outcomes

  1. Change in friendship Scale score

    Time frame: Pre-intervention (Baseline), week 6 and post-intervention (week 12)

    The scale consists of 5 core items, each with a 5-point frequency response (Almost always to Not at all).

    Total possible score range is 5-25. Higher scores indicate greater feelings of social isolation (worse study outcome).

  2. Change in UCLA Loneliness Scale score

    Time frame: Pre-intervention (Baseline), week 6 and post-intervention (week 12)

    This is a self -report scale with 20 items. Participants rate each item on a 4-point Likert scale:

    (1 = Never, 2 = Rarely, 3 = Sometimes, 4 = Often). Total possible score ranges from 20 to 80, with higher scores indicating greater perceived loneliness (worse study outcome).

  3. Change in Neuro-QOL score

    Time frame: Pre-intervention (Baseline), week 6 and post-intervention (week 12)

    Neuro-QOL ("Quality of Life in Neurological Disorders") consists of a scale designed to measure health-related quality of life across a variety of neurological conditions. The abbreviated form comprises short forms (8-10 items each) covering 13 key domains: physical, mental, and social health. Response format for each item ranges from "Never" to "Always" or severity levels like "None" to "Cannot do". Scores are summarized and represented with T-scores (mean = 50, SD = 10), derived from their respective calibrated item questionnaire. Higher scores correlate with worse outcome.

  4. Change in meaning and purpose score

    Time frame: Pre-intervention (Baseline), week 6 and post-intervention (week 12)

    This scale measures an individual's sense of meaning, purpose, and life satisfaction. Includes 8-9 items in the short form, with statements like "My life has meaning" or "I have a sense of purpose," rated on a 5-point (from 1=never to 5=always). Scores are expressed as T-scores (mean = 50, SD = 10). Higher scores represent better outcome (more positive well-being).

Secondary outcomes

  1. Change in Tech Experience and Comfort scale score

    Time frame: Pre-intervention (Baseline), week 6 and post-intervention (week 12)

    Measures confidence in using new or everyday technologies, reflecting both comfort and perceived ability. Includes 10 items, each beginning with the stem "I could use the new technology…".

    Participant will rate confidence on a 10-point scale (e.g., from "Not at all confident" to "Completely confident"). Total possible score range is 10-100, with better score correlating with greater confidence/comfort in using technology.

  2. Change in Perceived Stress score

    Time frame: Pre-intervention (Baseline), week 6 and post-intervention (week 12)

    Measures the degree to which situations in one's life are appraised as stressful.

    This is a 10-item scale that focuses on feelings of unpredictability, lack of control, and overload during the past month. Response format is with a 5-point Likert scale (0 = Never, 1 = Almost never, 2 = Sometimes, 3 = Fairly often, 4 = Very often). Total score range is 0-40. Higher scores correlate with greater perceived stress (worse outcome).

Study contacts

Contact information is provided by the study sponsor or research team.

Kayci Vickers, PhD

CONTACT

[email protected]

(404) 712-4849

Sponsors and collaborators

Lead sponsor

Emory University

Other

Collaborators

  • National Institute on Aging (NIA)

Registry information

Official study title

Evaluating Online Gameplay Intervention to Support Social Engagement in Older Adults With and Without Mild Cognitive Impairment (MCI)

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Dec 22, 2025
Registry last updated
Dec 22, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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