Systematic Multi-domain Alzheimer's Risk Reduction Trial (SMARRT)

Kaiser Permanente

Status: Completed

Conditions: Alzheimer Disease; Dementia

Treatments: Behavioral: SMARRT Intervention; Behavioral: Health Education Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT03683394

1R01AG057508

Details and patient eligibility

About

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.

Full 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.

Enrollment: 172 patients

Sex: All

Ages: 70 to 89 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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172 participants in 2 patient groups

SMARRT Intervention

Active Comparator group

Description:

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.

Treatment:

Behavioral: SMARRT Intervention

Health Education Intervention

Active Comparator group

Description:

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.

Treatment:

Behavioral: Health Education Intervention