[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07296133":3,"trial-entities:NCT07296133":105,"trial-summary:NCT07296133":109},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":40,"secondary_outcomes":54,"sex":61,"minimum_age":62,"maximum_age":63,"healthy_volunteers":64,"eligibility_criteria":65,"std_ages":82,"locations":85,"central_contacts":94,"overall_officials":100,"references":103,"see_also_links":104},"NCT07296133","2025P011653","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)","RECRUITING","2027-03","2025-12","2025-12-22","2025-12-08","Emory University","OTHER",true,"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.",[19],"Mild Cognitive Impairment",[],"INTERVENTIONAL","SUPPORTIVE_CARE",[24],"NA",{"count":26,"type":27},124,"ESTIMATED",[29,35],{"type":30,"name":31,"description":32,"armGroupLabels":33},"BEHAVIORAL","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.\n\nAll 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.\n\n* Participants will receive weekly calls from study staff to provide support and briefly query about social activities that week.\n* They will not receive reminders or be contacted by the study outside of the weekly phone calls, apart from mid intervention questionnaires.",[34],"Online Gameplay Intervention Group",{"type":30,"name":36,"description":37,"armGroupLabels":38},"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.",[39],"Wait-list control Group",[41,45,48,51],{"measure":42,"description":43,"timeFrame":44},"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).\n\nTotal 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)",{"measure":46,"description":47,"timeFrame":44},"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:\n\n(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).",{"measure":49,"description":50,"timeFrame":44},"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.",{"measure":52,"description":53,"timeFrame":44},"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).",[55,58],{"measure":56,"description":57,"timeFrame":44},"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…\".\n\nParticipant 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\u002Fcomfort in using technology.",{"measure":59,"description":60,"timeFrame":44},"Change in Perceived Stress score","Measures the degree to which situations in one's life are appraised as stressful.\n\nThis 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).","ALL","50 Years","85 Years",false,{"inclusion":66,"exclusion":75,"raw_text":81},[67,68,69,70,71,72,73,74],"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\u002Fhear computer screen","MoCA-Blind (converted to MoCA score) \\> 17","Existing diagnosis by HC professional","MoCA-Blind (converted to MoCA score) of 18-25","FAQ \\\u003C 9",[76,77,78,79,80],"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","Inclusion Criteria:\n\n* 50 to 85 years old\n* Living independently (note: can live in assisted living, but must have independently complete daily activities)\n* Fluent in English\n* Adequate visual and auditory acuity to see\u002Fhear computer screen\n* MoCA-Blind (converted to MoCA score) \\> 17\n\nAdditional Criteria for MCI Group:\n\n* Existing diagnosis by HC professional\n* MoCA-Blind (converted to MoCA score) of 18-25\n* FAQ \\\u003C 9\n\nExclusion Criteria:\n\n* Cognitive impairment secondary to stroke, TBI or other neurological cause without concern for neurodegenerative condition (e.g., Alzheimer's disease, vascular dementia, etc.)\n* Medical illnesses that would prevent participation\n* Major psychiatric disturbance meeting DSM V criteria in last year\n* Hx of substance abuse within last two years\n* Current psychoactive med use",[83,84],"ADULT","OLDER_ADULT",[86],{"facility":13,"status":8,"city":87,"state":88,"zip":89,"country":90,"geoPoint":91},"Atlanta","Georgia","30322","United States",{"lat":92,"lon":93},33.749,-84.38798,[95],{"name":96,"role":97,"phone":98,"email":99},"Kayci Vickers, PhD","CONTACT","(404) 712-4849","kayci.lynne.vickers@emory.edu",[101],{"name":96,"affiliation":13,"role":102},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":106,"biomarkers":108},[107],"Mild cognitive disorder",[],{"nct_id":4,"found":15,"summary":110,"prompt_version":120},{"design":111,"status":112,"heading":113,"summary":114,"follow_up":115,"word_count":116,"commitments":117,"compensation":118,"drugs_mentioned":119},"This study is an interventional study with a planned enrollment of 124 participants. Some participants will start the online gameplay right away, while others will be on a waitlist for 12 weeks before starting.","completed","GAMES Intervention for Mild Cognitive Impairment","This study is looking at whether playing online games can help people with and without mild cognitive impairment (MCI) feel more connected and less lonely. You would play online versions of common games like Connect 4 and Uno with a partner three times a week for 12 weeks. The study aims to see if this \"Online Gameplay Intervention\" can improve your feelings of friendship, loneliness, and overall quality of life. To join, you need to be between 50 and 85 years old, live independently, speak English fluently, and have good vision and hearing for a computer screen. If you have MCI, you also need a diagnosis from a healthcare professional. The study is currently unclear on its recruitment status and plans to enroll 124 people.","Participants will be followed for 12 weeks, with assessments at the beginning, 6 weeks, and 12 weeks.",125,"You would play online games three times a week for at least 15 minutes each session, for 12 weeks. You would also receive weekly phone calls from study staff and complete questionnaires at the beginning, at 6 weeks, and at 12 weeks.","Not stated in the trial record.",[31],"v2"]