Systematic Multi-domain Alzheimer's Risk Reduction Trial

Alzheimer Disease Clinical Trial

— SMARRT  

Official title:

Multidomain Alzheimers Risk Reduction Study (MARRS) Pilot

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03683394
• Other study ID #: 1R01AG057508
• Status: Completed
• Phase: N/A
• Start date: August 30, 2018
• Est. completion date: August 10, 2022

Study information

• Verified date: August 2023
• Source: Kaiser Permanente
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 172
• Est. completion date: August 10, 2022
• Est. primary completion date: August 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Alzheimer Disease
• Dementia

Intervention

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.
• 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).

Locations

Country	Name	City	State
United States	Kaiser Permanente Washington Health Research Institute	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Kaiser Permanente	University of California, San Francisco

Country where clinical trial is conducted

United States, 

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* Note: There are 51 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in Targeted Risk Factors	A composite Z-score for risk factors based on the following: the Rapid Assessment of Physical Activity for Older Adult (RAPA), steps per day averaged over 7 days; blood pressure measures averaged for each six-month period for participants with hypertension; the Pittsburgh Sleep Quality Index (PSQI); use of potentially harmful prescription medications; the Center for Epidemiologic Studies - Depression Scale (CES-D); hemoglobin A1c (HbA1c) values averaged over a 12-month time period; the Patient-Reported Outcomes Measurement Information System (PROMIS) Satisfaction with Social Activities, Short Form; and self-reported smoking. Higher score indicates greater risk factor burden. A z-score of 0 represents the population mean.; Treatment effects were estimated using LMMs for the changes from baseline to each follow-up assessment (6, 12, 18, and 24 months), with ATEs estimated by the average of the four visit-specific between-group differences in adjusted mean change from baseline.	2 Years
Secondary	Quality of Life Measure	Measured with Patient-Reported Outcomes Measurement Information System (PROMIS) Global Health. Higher score indicates better global health and quality of life; range = 0 to 20.	2 Years
Secondary	Number of Participants With Mild Cognitive Impairment, Alzheimer's Disease, and Dementia	Number of participants at follow up visits with Mild Cognitive Impairment, Alzheimer's Disease, and/or Dementia or with a low score on the Cognitive Abilities Screening Instrument (CASI) (<27 consistent with cognitive impairment). Lower score indicates poorer cognition; range is 0-33.	2 Years