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Systematic Multi-domain Alzheimer's Risk Reduction Trial

NCT03683394 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 172

Last updated 2023-09-21

Study results available
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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

Interventions

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.

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).

Sponsors & Collaborators

Principal Investigators

  • Sascha Dublin, MD, PhD · Kaiser Permanente

  • Kristine Yaffe, MD · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
70 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-08-30
Primary Completion
2022-08-10
Completion
2022-08-10

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03683394 on ClinicalTrials.gov