Systematic Multi-domain Alzheimer's Risk Reduction Trial

NCT03683394 | Completed Results DMC

• 1 other identifier: 1R01AG057508
• Study Type: interventional
• Target: 172
• Locations: 1 country
• Sites: 1

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.

Conditions

Dementia; Alzheimer Disease

Outcome Measures

Primary Outcomes (1)

• Cognitive Change

  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.

  2 Years

Secondary Outcomes (3)

• 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

Study Arms (2)

SMARRT Intervention

ACTIVE COMPARATOR

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

Health Education Intervention

ACTIVE COMPARATOR

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

Interventions

SMARRT Intervention BEHAVIORAL

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.

SMARRT Intervention

Health Education Intervention BEHAVIORAL

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).

Health Education Intervention

Eligibility Criteria

• Age: 70 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Kaiser Permanente: lead
• University of California, San Francisco: collaborator

Study Sites (1)

Kaiser Permanente Washington Health Research Institute

Seattle, Washington, 98101, United States

Location

Related Publications (52)

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MeSH Terms

Conditions

Dementia; Alzheimer Disease

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Mental Disorders; Tauopathies; Neurodegenerative Diseases

Limitations and Caveats

Our trial was initiated prior to the COVID-19 pandemic, but the shutdown shortened the enrollment period and necessitated administering the intervention and measuring the outcomes remotely.

Results Point of Contact

• Title: Dr. Kristine Yaffe
• Organization: The University of California, San Francisco

kristine.yaffe@ucsf.edu

(415) 476-7307

Study Officials

• Sascha Dublin, MD, PhD

  Kaiser Permanente

  PRINCIPAL INVESTIGATOR

• Kristine Yaffe, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: September 20, 2018
• First Posted: September 25, 2018
• Study Start: August 30, 2018
• Primary Completion: August 10, 2022
• Study Completion: August 10, 2022
• Last Updated: September 21, 2023
• Results First Posted: September 21, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)