Recruiting

Observational Study

Sponsor:

Emory University

Code:

NCT07296133

Conditions

Mild Cognitive Impairment

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

Interventions

Online Gameplay Intervention

Waitlist control

Study Details

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).

Conditions

Mild Cognitive Impairment

Study ID

NCT07296133

Start date

Dec 8, 2025

Status verified date

Dec, 2025

Completion date

Mar, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 50 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

124 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: 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.

other: 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.

Interventions

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.

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 measure

  • 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) ]

Central Contacts and Locations

Central contacts

Kayci Vickers, PhD

(404) 712-4849kayci.lynne.vickers@emory.edu

Locations

Emory University

Recruiting

Atlanta, Georgia, United States, 30322

More Information

Sponsor

Emory University

Last update posted

Dec 22, 2025

Last verified

Dec, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Emory University on 2025-12-22.