Systematic Multi-domain Alzheimer's Risk Reduction Trial
Condition: Dementia; Alzheimer Disease
MeSH terms: Alzheimer Disease
Study type: Interventional

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.
    

Intervention name(s): SMARRT Intervention; Health Education Intervention
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Interventionists will follow a standard protocol for delivering the SMARRT intervention that allows for personalization of the specific risk reduction action plan; these plans will evolve over time according to participant progress, motivation and preferences or newly identified risk factors. Staff will use a tracking database to record information for each participant, including session dates, identified risk factors, motivational barriers and important values, and the outcome of discussions around developing goals. For each participant, the exact number and mode (phone or in-person) of contacts will differ, but we will aim to have at least 1 contact per month with each participant. Best practice will include in-person meetings twice a year during the 2-year intervention period.; Participants randomized to the Health Education (HE) group will receive mailed materials (typically 1-2 pages) every 3 months. This will include general information on Alzheimer's and dementia risk reduction using materials from sources such as the Alzheimer's Association and educational materials commonly provided as part of routine care at Kaiser Permanente Washington (KPWA).
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomized after baseline assessments to the SMARRT intervention arm or Health Education (HE) control arm. Randomization will be stratified by clinic, race/ethnicity (non-Hispanic white vs. non-white or Hispanic) and age (70-79, 80-89).
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention