Systematic Multi-domain Alzheimer's Risk Reduction Trial (SMARRT)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03683394|
Recruitment Status : Active, not recruiting
First Posted : September 25, 2018
Last Update Posted : September 10, 2020
|Condition or disease||Intervention/treatment||Phase|
|Dementia Alzheimer Disease||Behavioral: SMARRT Intervention Behavioral: Health Education Intervention||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||172 participants|
|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)|
|Official Title:||Multidomain Alzheimers Risk Reduction Study (MARRS) Pilot|
|Actual Study Start Date :||August 30, 2018|
|Estimated Primary Completion Date :||March 31, 2022|
|Estimated Study Completion Date :||March 31, 2022|
Active Comparator: 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.
Behavioral: SMARRT Intervention
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.
Active Comparator: 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.
Behavioral: Health Education Intervention
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).
- 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.
- Improvement in Targeted Risk Factors [ Time Frame: 2 Years ]Risk factors include poorly controlled hypertension, diabetes with evidence of hyper- or hypoglycemia, depressive symptoms, poor sleep quality, contraindicated medications, physical inactivity, low cognitive stimulation, social isolation, poor diet, and smoking. We will use a combination of validated objective and self-report measures as well as electronic health record (EHR) data to assess changes in Alzheimer's risk factors.
- Physical Performance [ Time Frame: 2 Years ]Measured with Short Physical Performance Battery (SPPB)
- Functional Ability [ Time Frame: 2 Years ]Measured with Cognitive Function Instrument (CFI)
- Quality of Life Measure [ Time Frame: 2 Years ]Measured with Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health
- Incidence of Mild Cognitive Impairment, Alzheimer's Disease, and Dementia [ Time Frame: 2 Years ]consensus conferences using standard clinical criteria
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03683394
|United States, Washington|
|Kaiser Permanente Washington Health Research Institute|
|Seattle, Washington, United States, 98101|
|Principal Investigator:||Eric B Larson, MD, MPH||Kaiser Permanente Washington|
|Principal Investigator:||Kristine Yaffe, MD||University of California, San Francisco|