Mild Cognitive ImpairmentNCT07296133
GAMES Intervention in MCI (Mild Cognitive Impairment)
A study testing Online Gameplay Intervention in people with Mild Cognitive Impairment, run by Emory University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Mild Cognitive Impairment
- What is being tested?
- Online Gameplay Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Dec 2025to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
Show all 9Show fewer
- Existing diagnosis by HC professional
- MoCA-Blind (converted to MoCA score) of 18-25
- FAQ < 9
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Emory University
Atlanta, Georgia, 30322
About this study
Official title: Evaluating Online Gameplay Intervention to Support Social Engagement in Older Adults With and Without Mild Cognitive Impairment (MCI)
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).
Read the 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.
- Conditions
- Mild Cognitive Impairment
- Being tested
- Online Gameplay Intervention, Waitlist control
- Medical subject headings
- Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online Gameplay InterventionBehavioural
-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 controlBehavioural
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Online Gameplay Intervention Group | Experimental | 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. Receives: Behavioral: Online Gameplay Intervention |
| Wait-list control Group | Other | 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. Receives: Behavioral: Waitlist control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in friendship Scale score
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).
Measured: Pre-intervention (Baseline), week 6 and post-intervention (week 12)
Change in UCLA Loneliness Scale score
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).
Measured: Pre-intervention (Baseline), week 6 and post-intervention (week 12)
Change in Neuro-QOL score
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.
Measured: Pre-intervention (Baseline), week 6 and post-intervention (week 12)
Change in meaning and purpose score
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).
Measured: Pre-intervention (Baseline), week 6 and post-intervention (week 12)
Secondary outcomes (2)
Change in Tech Experience and Comfort scale score
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.
Measured: Pre-intervention (Baseline), week 6 and post-intervention (week 12)
Change in Perceived Stress score
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).
Measured: Pre-intervention (Baseline), week 6 and post-intervention (week 12)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Dec 2025
- Study start8 Dec 2025
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mild Cognitive ImpairmentStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Responsible party
- Principal investigator, Kayci Vickers, Emory University
- Investigators
- Kayci Vickers, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07296133
- Sponsor's protocol ID
- 2025P011653
- Other IDs
- 1R44AG078009-01
- Status last verified
- Dec 2025
- First submitted
- 18 Dec 2025
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual participant data that underlies results reported in as outcomes in publication of RCT results, after being de-identified (includes tables, graphs, appendices, etc.)
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Online Gameplay Intervention to Support Social Engagement in Older Adults With and Without Mild Cognitive Impairment (MCI)
- ClinicalTrials.gov ID
- NCT07296133
- Acronym / sponsor ID
- 2025P011653
- Conditions
- Mild Cognitive Impairment
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- National Institute on Aging (NIA)
- Study start
- 8 Dec 2025 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 22 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Online Gameplay Intervention Group | Experimental | Behavioral: Online Gameplay InterventionParticipants 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. |
| Wait-list control Group | Other | Behavioral: Waitlist controlParticipants 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. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Online Gameplay Intervention Group |
| 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. | Behavioural | Wait-list control Group |
Primary outcome
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).
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).
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.
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).
2 secondary outcomes
Change in Tech Experience and Comfort scale score
Time frame: Pre-intervention (Baseline), week 6 and post-intervention (week 12)
Change in Perceived Stress score
Time frame: Pre-intervention (Baseline), week 6 and post-intervention (week 12)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2025.
- Individual participant dataSharing planned: Yes. Individual participant data that underlies results reported in as outcomes in publication of RCT results, after being de-identified (includes tables, graphs, appendices, etc.)
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kayci Vickers, PhD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online Gameplay Intervention in people with Mild Cognitive Impairment, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kayci Vickers, PhD ((404) 712-4849, kayci.lynne.vickers@emory.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in friendship Scale score (time frame: Pre-intervention (Baseline), week 6 and post-intervention (week 12)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Dec 2025.