Multidomain Alzheimers Risk Reduction Study (MARRS) Pilot
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Dementia
- Sponsor
- Kaiser Permanente
- Enrollment
- 172
- Locations
- 1
- Primary Endpoint
- Cognitive Change
- Status
- Completed
- Last Updated
- 2 years ago
Overview
Brief Summary
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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Cognitive Change
Time Frame: 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.
Secondary Outcomes
- 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)