Evaluating Online Gameplay Intervention to Support Social Engagement in Older Adults With and Without Mild Cognitive Impairment (MCI)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 124
- 试验地点
- 1
- 主要终点
- Change in friendship Scale score
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Change in friendship Scale score
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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).
次要结局
- Change in Tech Experience and Comfort scale score(Pre-intervention (Baseline), week 6 and post-intervention (week 12))
- Change in Perceived Stress score(Pre-intervention (Baseline), week 6 and post-intervention (week 12))
研究者
Kayci Vickers
Assistant Professor
Emory University