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| ID | Type | Description | Link |
|---|---|---|---|
| 1R44AG078009-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Aging (NIA) | NIH |
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Online Gameplay Intervention Group | Experimental | Participants will receive:
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| Wait-list control Group | Other | Participants will receive:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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.
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| Measure | Description | Time Frame |
|---|---|---|
| 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). | 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). | 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. | 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). | Pre-intervention (Baseline), week 6 and post-intervention (week 12) |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Additional Criteria for MCI Group:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kayci Vickers, PhD | Contact | (404) 712-4849 | kayci.lynne.vickers@emory.edu |
| Name | Affiliation | Role |
|---|---|---|
| Kayci Vickers, PhD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University | Recruiting | Atlanta | Georgia | 30322 | United States |
Individual participant data that underlies results reported in as outcomes in publication of RCT results, after being de-identified (includes tables, graphs, appendices, etc.)
Data will be available within 3 months of acceptance for publication and will end 5 years after initial publication.
Data will be shared with researchers who provide a methodologically sound proposal, to achieve aims in approved proposal.
Proposals should be directed to kvicker@emory.edu. To gain access, data requestors will need to sign a data access agreement. Data will be made available for 5 years.
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| ID | Term |
|---|---|
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
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| 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. |
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| 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). | Pre-intervention (Baseline), week 6 and post-intervention (week 12) |