Multidomain Alzheimers Risk Reduction Study (MARRS) Pilot
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 172
- 试验地点
- 2
- 主要终点
- Cognitive Change
研究概览
简要总结
The primary goal of this randomized controlled trial (RCT) is to pilot-test a personalized, pragmatic, multi-domain Alzheimer's disease risk reduction intervention in a U.S. integrated healthcare delivery system.
详细描述
We propose to randomize 200 higher-risk older adults (age 70-89 with low-normal performance on cognitive testing and 2+ modifiable risk factors that will be targeted by our intervention) to a two-year Systematic Multi-Domain Alzheimer's Risk Reduction Trial (SMARRT) intervention or a Health Education (HE) control.
The SMARRT team will work with participants randomized to the intervention arm to develop a tailored action plan to address risk reduction. Targeted areas will include: increasing physical, mental and social activities; controlling cardiovascular risk factors (diabetes, hypertension); quitting smoking; reducing depressive symptoms; improving sleep; neuroprotective diet; and decreasing use of potentially harmful medications. HE participants will receive periodic handouts on these topics by mail.
Changes made to the protocol due to COVID-19, i.e. switching to telephone data collection, will likely limit our ability to examine cognitive change effectively, as several of the most important cognitive tests cannot be administered via telephone.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 70 Years 至 89 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •70-89 Years of Age
- •Fluent in the English Language
- •Low-normal performance on a brief telephone cognitive screen, measured using the Cognitive Abilities Screening Instruments (CASI). Low-normal scores are defined as 26-
- •Has at least two additional risk factors that will be targeted by the intervention.
排除标准
- •Residing in a skilled nursing or rehabilitation facility
- •Receiving palliative care or hospice services
- •Charlson comorbidity index score of greater than 5
- •Bipolar illness or schizophrenia
- •Current alcohol or drug use disorder
- •Receiving chronic opioid therapy
- •Parkinson's disease, amyotrophic lateral sclerosis, or multiple sclerosis
- •Severe visual or hearing impairment
- •Requests not to be contacted or not to have their medical record reviewed for research
- •Prior evidence of dementia
结局指标
主要结局
Cognitive Change
时间窗: 2 Years
Cognitive function will be measured by the modified Neuropsychological Test Battery (mNTB) global score, which is a composite z-score, an average of z-scores from tests of several cognitive domains. The total score is reported. Higher values signify higher cognitive performance. A z-score of 0 represents the population mean. Treatment effects were estimated using linear mixed models (LMMs) for the changes from baseline to each follow-up assessment (6, 12, 18, and 24 months), with average treatment effects (ATEs) estimated by the average of the four visit-specific between-group differences in adjusted mean change from baseline. Changes made to the protocol due to Covid-19, i.e., switching to telephone data collection, will likely limit our ability to examine cognitive change effectively, as several of the most important cognitive tests cannot be administered via telephone.
次要结局
- Change in Targeted Risk Factors(2 Years)
- Quality of Life Measure(2 Years)
- Number of Participants With Mild Cognitive Impairment, Alzheimer's Disease, and Dementia(2 Years)