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GAMES Intervention in MCI (Mild Cognitive Impairment)

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07296133
Enrollment
124
Registered
2025-12-22
Start date
2025-12-08
Completion date
2027-03-31
Last updated
2025-12-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mild Cognitive Impairment

Brief summary

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

BEHAVIORALOnline 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.

BEHAVIORALWaitlist 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.

Sponsors

National Institute on Aging (NIA)
CollaboratorNIH
Emory University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Change in friendship Scale scorePre-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).
Change in UCLA Loneliness Scale scorePre-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).
Change in Neuro-QOL scorePre-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.
Change in meaning and purpose scorePre-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

MeasureTime frameDescription
Change in Tech Experience and Comfort scale scorePre-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.
Change in Perceived Stress scorePre-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).

Countries

United States

Contacts

Primary ContactKayci Vickers, PhD
kayci.lynne.vickers@emory.edu(404) 712-4849

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026