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
- 1
- 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
研究组 & 干预措施
SMARRT Intervention
The SMARRT intervention team will use a standardized procedure to develop an individualized Alzheimer's risk profile for each participant randomized to the SMARRT intervention arm. Participants will then meet in-person with an interventionist to review their risk profile and develop an initial personalized risk reduction action plan. For the few participants enrolled during COVID, initial interventionist visits were conducted by phone. Targeted areas will include: increasing physical, mental and social activities; quitting smoking; healthy diet; controlling cardiovascular risk factors (diabetes, hypertension), including avoiding hypoglycemia in people with diabetes; reducing depressive symptoms; improving sleep; and decreasing use of potentially harmful medications.
干预措施: SMARRT Intervention (Behavioral)
Health Education Intervention
Participants in the Health Education arm will be mailed general information that will address factors that will be targeted in the SMARRT intervention, including physical, mental and social engagement; management of cardiovascular risk factors; quitting smoking, healthy diet; depression; sleep; and contraindicated medications. HE participants will not be provided with personalized information about their risk of Alzheimer's and dementia.
干预措施: Health Education Intervention (Behavioral)
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)