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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
Sponsor:
Collaborator:
University of California, San Francisco
Information provided by (Responsible Party):
Kaiser Permanente

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.

Condition or disease Intervention/treatment Phase
Dementia Alzheimer Disease Behavioral: SMARRT Intervention Behavioral: Health Education Intervention Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 172 participants
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
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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).




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. Physical Performance [ Time Frame: 2 Years ]
    Measured with Short Physical Performance Battery (SPPB)

  3. Functional Ability [ Time Frame: 2 Years ]
    Measured with Cognitive Function Instrument (CFI)

  4. Quality of Life Measure [ Time Frame: 2 Years ]
    Measured with Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health

  5. Incidence of Mild Cognitive Impairment, Alzheimer's Disease, and Dementia [ Time Frame: 2 Years ]
    consensus conferences using standard clinical criteria



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   70 Years to 89 Years   (Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 26-29.
  • 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

Information from the National Library of Medicine

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


Locations
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United States, Washington
Kaiser Permanente Washington Health Research Institute
Seattle, Washington, United States, 98101
Sponsors and Collaborators
Kaiser Permanente
University of California, San Francisco
Investigators
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Principal Investigator: Eric B Larson, MD, MPH Kaiser Permanente Washington
Principal Investigator: Kristine Yaffe, MD University of California, San Francisco
Publications:
Alzheimer's Disease International. World Alzheimer Report 2015: The Global Impact of Dementia, An Analysis of Prevalence, Incidence, Cost and Trends. London: Alzheimer's Disease International (ADI); 2015.
Alzheimer's Association. 2017 Alzheimer's disease facts and figures. Alzheimer's & dementia : the journal of the Alzheimer's Association. 2017;13:325-373.
Fagan T. Clinical Trials of Intravenous Bapineuzumab Halted. Alzheimer Research Forum onlineAugust 8, 2012.
Fagan T. Lilly Halts IDENTITY Trials as Patients Worsen on Secretase Inhibitor. Alzheimer Research Forum onlineAugust 18, 2010.
Jeffrey S. IVIG Fails in Phase 3 for Alzheimer's. Medscape Today May 7, 2013.
Radloff LS. The CES-D scale: A self-report depression scale for research in the general population. Applied Psychological Measurement. 1977;1(3):385-401.
Cohen J. Statistical power analysis for the behavioral sciences (2nd ed). Hillsdale, N.J.: Lawrence Earlbaum Associates; 1988.

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Responsible Party: Kaiser Permanente
ClinicalTrials.gov Identifier: NCT03683394    
Other Study ID Numbers: 1R01AG057508 ( U.S. NIH Grant/Contract )
First Posted: September 25, 2018    Key Record Dates
Last Update Posted: September 10, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Alzheimer Disease
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Tauopathies
Neurodegenerative Diseases
Neurocognitive Disorders
Mental Disorders