This project will develop a "Stroke Awareness Team" including training of Oneida Health Service Coaches working in partnership with the UW team for a population-based health awareness program. This team will develop a series of Oneida Nation Healthy Living and Stroke Awareness Events (from now on health events) to provide education as to the severity of the problem as well as our standard therapies for lifestyle change and risk factor avoidance. This will include education of the healthy members of the tribe including the children to identify signs of stroke and TIA in their elders as well as to develop healthy lifestyles at the earliest of ages to influence the elders to modify their risks.
The study will enroll 100 high risk tribe members and 20 low stroke risk tribe members. Each of these will be further studied for their atherosclerotic load by ultrasound measurements at the carotid bifurcation for presence of plaque as well as its stability or instability during pulsation. Enrolled participants will also receive assessment of biomarkers for stroke risk, including stroke-related vascular cognitive decline, an early and modifiable marker of TIA risk and serum analysis for glucose, cholesterol, microRNA and key proteins felt to be biomarkers of stroke. The high risk participants will be randomized into two groups, and data analyzed by gender, age, history of cerebrovascular events, and the presence or absence of atherosclerosis in their carotid bifurcation including equal numbers of participants that in spite of high risk, have not yet deposited plaque. * One group will receive advice about standard therapy and information concerning risk factor guidelines to improve health awareness. * The other group will receive the same plus intensive initiation of the American Heart Association Guidelines for Management of Risk Factors with at least quarterly individual face-to-face coaching meetings on lifestyle change and adherence to treatment. At the end of 2-year follow-up, all groups will be reassessed for adherence to the program, atherosclerotic plaque progression or regression and its stability, serum biomarker response to therapy interventions, successful risk factor modification, vascular cognitive decline and incidence of stroke and TIA. Intention to treat analysis will estimate the efficacy of health coaching and will use G-estimation to correct for issues of non-compliance and discontinuation. Groups will be compared for change in both risk factors and outcomes. Vascular cognitive decline is an important symptom of cerebrovascular disease which may precede a physical stroke with devastating results. Extensive preliminary data show that the frequency of this is surprisingly common in high risk patients and may predispose patients to later dementia. Vascular cognitive decline is a risk factor for stroke, but also is modifiable. A prior small study showed that intervention could stop the rate of decline. The study will see if this predicts participants at greatest risk for stroke that would improve with an intensive intervention program.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
120
The following assessment will occur: health assessment, blood pressure, BMI, history TIA/stroke, blood mRNA and protein analysis, ultrasound, cognitive assessment, stroke education, intensive coaching face-to-face. Furthermore, this group will receive intensive initiation of the American Heart Association Guidelines for Management of Risk Factors with individual face-to-face coaching meetings on lifestyle change and adherence to treatment on at a least quarterly basis.
The following assessment will occur: health assessment, blood pressure, BMI, history TIA/stroke, blood mRNA and protein analysis, ultrasound, cognitive assessment, stroke education.
Control participants will undergo the same study events as the Low Risk group, except without receiving information and advice about eliminating stroke risk factors.
University of Wisconsin-Madison
Madison, Wisconsin, United States
Oneida Comprehensive Health Division
Oneida, Wisconsin, United States
Change in Incidence of Stroke or TIA
Number of incidences of stroke or TIA during the study
Time frame: baseline and 2 years
Change in Number of Participants that meet AHA Simple Rules for Diastolic Blood Pressure
Number of Participants with diastolic blood pressure \< 90 mmHg
Time frame: baseline and 2 years
Change in Number of Participants that meet AHA Simple Rules for Systolic Blood Pressure
Number of Participants with systolic blood pressure \< 140 mmHg
Time frame: baseline and 2 years
Change in Number of Participants that meet AHA Simple Rules for Total Cholesterol
Number of Participants with total cholesterol \< 200 mg/dL
Time frame: baseline and 2 years
Change in Number of Participants that meet AHA Simple Rules for Low Density Lipoprotein Cholesterol (LDL-C)
Number of Participants with LDL-C \< 100 mg/dL
Time frame: baseline and 2 years
Change in Number of Participants that meet AHA Simple Rules for High Density Lipoprotein Cholesterol (HDL-C)
Number of Participants with HDL-C \> 60 mg/dL
Time frame: baseline and 2 years
Change in Number of Participants that meet AHA Simple Rules for Blood Sugar
Number of Participants with A1c \< 7.5
Time frame: Baseline and 2 years
Change in Number of Participants that meet AHA Simple Rules for Body Mass Index (BMI)
Number of Participants who improve BMI
Time frame: Baseline and 2 years
Change in Number of Participants that meet AHA Simple Rules for Smoking Status
Number of Participants who Smoke
Time frame: baseline and 2 years
Change in TabCAT Score
The Tablet-based Cognitive Assessment Tool will examine avorites (rote verbal learning and memory), match (processing speed), flanker (executive functions), and line orientation (visuospatial abilities).
Time frame: baseline and 2 years
Change in Montreal Cognitive Assessment (MoCA) Vancouver Island Coastal First score
Montreal Cognitive Assessment will assess vascular cognitive decline
Time frame: baseline and 2 years
Change in Plaque Area
Measured via carotid ultrasound.
Time frame: baseline and 2 years
Change in pulsatility index in carotid arteries
Measured via carotid ultrasound. This index is a unitless measurement calculated: peak systolic velocity - end diastolic velocity, divided by the mean velocity, higher values are thought to represent increased resistance to blood flow
Time frame: baseline and 2 years
Correlation of carotid plaque grayscale texture features (grayscale median values [no units]) to stroke risk factors
Measured via carotid ultrasound
Time frame: baseline and 2 years
Change in Circulating Dipeptidyl Peptidase (DPPIV)
DPPIV is a circulating protein associated with cardiovascular risk. This will be measured via blood draw at baseline and 2 years.
Time frame: Baseline and 2 years
Change in Circulating Galectin3 (Gal-3)
Gal-3 is a circulating protein associated with cardiovascular risk. This will be measured via blood draw at baseline and 2 years.
Time frame: baseline and 2 years
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