Brain Health Together: A Live-Streaming Group-Based Digital Program
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 208
- 试验地点
- 2
- 主要终点
- Alzheimer's Disease Risk Index - Short Form-Change (ANU-ADRI-SF)
研究概览
简要总结
The purpose of this study is to develop and test a comprehensive Brain Health Together program for older adults living with cognitive decline.
详细描述
Older adults with cognitive decline (including either mild cognitive impairment [MCI] or subjective cognitive decline [SCD]) represent a large market with important unmet needs. Approximately one in three older adults (18 million Americans) are currently living with cognitive decline, which places them at increased risk of developing Alzheimer's disease and related dementias (ADRD). There are no medications that can prevent development of dementia in people with cognitive decline; however, there is growing evidence that behavioral interventions targeting modifiable dementia risk factors-such as increasing physical activity and reducing social isolation-may help improve cognitive function and could potentially delay dementia onset. Preliminary results suggest that Moving TogetherTM program is associated with significant improvements in cognitive function, physical function, social isolation, and self-regulation as well as increased default mode network connectivity on pre/post resting state functional magnetic resonance imaging scans in people with cognitive decline. The investigators believe that these benefits would be even greater if Moving Together were combined with a comprehensive brain health coaching program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 55 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •English language fluency;*
- •live in U.S.;
- •cognitive decline (subjective cognitive decline OR diagnosis of mild cognitive impairment in the past 12 months)
- •ready to make lifestyle changes to improve brain health;
- •have 2 or more brain health risk factors (e.g., low physical activity, depression, hypertension, diabetes, etc)
- •have a desktop or laptop computer or iPad/tablet with a video camera;
- •have broadband internet access;
- •able to participate in online, live-streaming classes with two-way video
排除标准
- •Candidates meeting any of the exclusion criteria will not be eligible to participate.
- •Alzheimer's disease or dementia
- •- Major neurological disorder (e.g., Parkinson's disease, Multiple Sclerosis, amyotrophic Lateral Sclerosis)
- •Schizophrenia or other psychotic disorder
- •Autism or autism spectrum disorder
- •Major mood or anxiety disorder that is not well-controlled (e.g., symptoms of depression or anxiety that made it hard to do daily tasks in past 6 months)
- •Fracture of spine ("compression fracture") in the past 12 months
- •Vertigo or severe dizziness in the past 12 months
- •Severe vision or hearing impairment (e.g., unable to see and hear well enough to watch a movie on TV);
- •Stroke or heart attack in the past 12 months
- •Physical limitation that would restrict ability to participate (e.g., use wheelchair or walker to get around home, unable to stand up from sitting without assistance)
- •Currently in another research study that could confound results of this study (e.g., drug study or other study to improve brain health)
- •Previous participation in Moving Together or Brain Health Together
- •Limited life expectancy (e.g., enrolled in hospice, undergoing cancer treatment)
- •If participants are not sure about certain conditions, they will be asked to describe their condition, and the research team will determine whether they meet eligibility criteria or not.
研究组 & 干预措施
Brain Health Academy
Participants in this arm will watch expert videos on a wide range of brain health topics and will complete quizzes for 2.5 hours a week for 12 weeks (30 hours total)
干预措施: Brain Health Academy (Behavioral)
Brain Health Together
Participants in this arm will participate in online, live-streaming Moving Together classes (1 hour a week) and group brain health classes (1 hour a week) and will work 1-on-1 with a brain health coach to set personalized risk reduction goals (0.5 hours a week) for 12 weeks (30 hours total)
干预措施: Brain Health Together (Behavioral)
Brain Health Together Plus
Participants in this arm will participate in the full Brain Health Together program for 12 weeks (30 hours) followed by weekly group classes and six 1-on-1 coaching sessions for another 12 weeks (additional 15 hours; 45 hours total)
干预措施: Maintain Brain Health Together (Behavioral)
结局指标
主要结局
Alzheimer's Disease Risk Index - Short Form-Change (ANU-ADRI-SF)
时间窗: Baseline and 3 months
This is a validated measure that combines validated component measures of individual dementia risk factors and also provides a summary dementia risk score. It includes items related to demographics (age, sex, education), obesity, diabetes, hypercholesterolemia, head injury, depression, physical activity, cognitive activity, social isolation, alcohol consumption, smoking, pesticide exposure, and fish intake. Test scores with be combines to create a single global composite score. Cognitive scores are standardized, mean=0, SD=1, expected range: -6 to +6 , highest score reflects the better outcome.
Maintain Your Brain Online Cognitive Test Battery-Change
时间窗: Baseline and 3 months
These are standard cognitive tests in three domains: attention, executive function, and learning/memory. individual test scores will be converted to standard scores using the means and standard deviations (SDs) of the study population. Tests within each domain will be averaged to create domain scores, and the three domain scores will then be averaged to create a single global composite score. Cognitive scores are standardized, mean=0, SD=1, expected range: -6 to +6 , highest score reflects the better outcome.
Creyos Cognitive Composite - 3 Month
时间窗: Baseline to 3 months
The Creyos online cognitive test battery included digit span, feature match, grammatical reasoning, paired associates, and token search. We converted raw scores to standardized z scores for each test using the group baseline mean and standard deviation. We then summed the standardized scores to create a composite cognitive score and re-standardized the composite score using the group baseline mean and standard deviation (baseline mean=0, SD=1). Positive change reflects improved cognitive performance.
Alzheimer's Disease Risk Index - Short Form-Change (ANU-ADRI-SF) - 3 Month Change
时间窗: Baseline to 3 months
This is a validated measure that combines validated component measures of individual dementia risk factors and also provides a summary dementia risk score. We created a modified version that only included risk factors that are modifiable and targeted by our intervention (depression, physical activity, cognitive activity, social isolation, alcohol consumption, smoking, and fish intake) using the weights from the original score. We then converted the calculated score to a z score using the group baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect increased dementia risk; negative scores reflect reduced dementia risk.
Creyos Cognitive Composite - 6 Month Change
时间窗: Baseline to 6 months
The Creyos online cognitive test battery included digit span, feature match, grammatical reasoning, paired associates, and token search. We converted raw scores to standardized z scores for each test using the group baseline mean and standard deviation. We then summed the standardized scores to create a composite cognitive score and re-standardized the composite score using the group baseline mean and standard deviation (baseline mean=0, SD=1). Positive change reflects improved cognitive performance.
Alzheimer's Disease Risk Index - Short Form-Change (ANU-ADRI-SF) - 6 Month Change
时间窗: Baseline to 6 months
This is a validated measure that combines validated component measures of individual dementia risk factors and also provides a summary dementia risk score. We created a modified version that only included risk factors that are modifiable and targeted by our intervention (depression, physical activity, cognitive activity, social isolation, alcohol consumption, smoking, and fish intake) using the weights from the original score. We then converted the calculated score to a z-score using the group baseline mean and SD (baseline mean=0, SD=1). Positive change scores reflect increased dementia risk; negative scores reflect reduced dementia risk.
次要结局
- Mind-body awareness-Change(Baseline and 3 months)
- Depression-Change(Baseline and 3 months)
- Emotional well-being-Change(Baseline and 3 months)
- Self-efficacy/Confidence-Change(Baseline and 3 months)
- Cognitive activity-Change(Baseline and 3 months)
- Smoking-Change(Baseline and 3 months)
- Global quality of life-Change(Baseline and 3 months)
- Diet-Change(Baseline and 3 months)
- Obesity/weight-Change(Baseline and 3 months)
- Physical activity-Change(Baseline and 3 months)
- Loneliness / social isolation-Change(Baseline and 3 months)
- Alcohol-Change(Baseline and 3 months)
- Sleep-Change(Baseline and 3 months)
- Loneliness / Social Isolation - 3 Month Change(Baseline to 3 months)
- Depression - 3 Month Change(Baseline to 3 months)
- Cognitive Activity - 3 Month Change(Baseline and 3 months)
- Physical Activity - 3 Month Change(Baseline to 3 months)
- Emotional Well-being - 3 Month Change(Baseline to 3 months)
- Self-regulation - 3 Month Change(Baseline to 3 months)
- Diet - 3 Month Change(Baseline and 3 months)
- Sleep Disturbance - 3 Month Change(Baseline to 3 months)
- Self-efficacy/Confidence 3 Month Change(Baseline to 3 months)
- Global Quality of Life - Physical - 3 Month Change(Baseline to 3 months)
- Global Quality of Life - Mental - 3 Month Change(Baseline to 3 months)
- Loneliness / Social Isolation - 6 Month Change(Baseline to 6 months)
- Depression - 6 Month Change(baseline to 6 months)
- Cognitive Activity - 6 Month Change(Baseline to 6 months)
- Physical Activity - 6 Month Change(Baseline to 6 months)
- Emotional Well-being - 6 Month Change(0 to 6 months)
- Self-Regulation - 6 Month Change(0 to 6 months)
- Diet - 6 Month Change(0 to 6 months)
- Sleep Disturbance - 6 Month Change(0 to 6 months)
- Self-efficacy/Confidence - 6 Month Change(0 to 6 months)
- Global Quality of Life - Physical - 6 Month Change(0 to 6 months)
- Global Quality of Life - Mental - 6 Month Change(0 to 6 months)