Systematic Multi-domain Alzheimer's Risk Reduction Trial
NCT ID: NCT03683394
Last Updated: 2023-09-21
Study Results
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View full resultsBasic Information
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COMPLETED
NA
172 participants
INTERVENTIONAL
2018-08-30
2022-08-10
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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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.
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 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.
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).
Interventions
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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).
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
70 Years
89 Years
ALL
No
Sponsors
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University of California, San Francisco
OTHER
Kaiser Permanente
OTHER
Responsible Party
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Principal Investigators
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Sascha Dublin, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Kaiser Permanente
Kristine Yaffe, MD
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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Kaiser Permanente Washington Health Research Institute
Seattle, Washington, United States
Countries
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References
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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