Stroke Prevention in the Wisconsin Native American Population

NCT04382963 | Completed

• 4 other identifiers: 2019-1550A535700SMPH/NEURO SURG/NEURO SURGProtocol Version 11/12/2020
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Stroke; Atherosclerosis

Keywords

Stroke; Atherosclerosis; Native American; Risk factor modification; Proteonomics; Genomics

Outcome Measures

Primary Outcomes (11)

• Change in Incidence of Stroke or TIA

  Number of incidences of stroke or TIA during the study

  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

  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

  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

  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

  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

  baseline and 2 years

• Change in Number of Participants that meet AHA Simple Rules for Blood Sugar

  Number of Participants with A1c \< 7.5

  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

  Baseline and 2 years

• Change in Number of Participants that meet AHA Simple Rules for Smoking Status

  Number of Participants who Smoke

  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).

  baseline and 2 years

• Change in Montreal Cognitive Assessment (MoCA) Vancouver Island Coastal First score

  Montreal Cognitive Assessment will assess vascular cognitive decline

  baseline and 2 years

Secondary Outcomes (5)

• Change in Plaque Area

  baseline and 2 years

• Change in pulsatility index in carotid arteries

  baseline and 2 years

• Correlation of carotid plaque grayscale texture features (grayscale median values [no units]) to stroke risk factors

  baseline and 2 years

• Change in Circulating Dipeptidyl Peptidase (DPPIV)

  Baseline and 2 years

• Change in Circulating Galectin3 (Gal-3)

  baseline and 2 years

Other Outcomes (2)

• Change in Serum microRNA

  baseline and 2 years

• Compliance Rates

  2 years

Study Arms (3)

High Risk- intense coaching

OTHER

age ≥ 55 with MORE than three of the following risk factors: * History of TIA/Stroke * History of Coronary Artery disease * History of Hypertension and/or current elevated blood pressure * History of Diabetes * Current smoker * BMI ≥30

Other: High Risk - intensive coaching

High Risk - standard care

OTHER

age ≥ 55 with MORE than three of the following risk factors: * History of TIA/Stroke * History of Coronary Artery disease * History of Hypertension and/or current elevated blood pressure * History of Diabetes * Current smoker * BMI ≥30

Other: High Risk - standard care

Low risk - control

OTHER

age ≥ 55 with LESS than three of the following risk factors: * History of TIA/Stroke * History of Coronary Artery disease * History of Hypertension and/or current elevated blood pressure * History of Diabetes * Current smoker * BMI ≥30

Other: Low Risk - control

Interventions

High Risk - intensive coaching OTHER

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.

High Risk- intense coaching

High Risk - standard care OTHER

The following assessment will occur: health assessment, blood pressure, BMI, history TIA/stroke, blood mRNA and protein analysis, ultrasound, cognitive assessment, stroke education.

High Risk - standard care

Low Risk - control OTHER

Control participants will undergo the same study events as the Low Risk group, except without receiving information and advice about eliminating stroke risk factors.

Low risk - control

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants receiving health care through the Oneida Health Council Program
• Participants deemed to be at high risk for stroke by modified Framingham assessment of medical history, including cerebral cardiovascular symptomatology, hypertension, diabetes, smoking, BMI
• Willingness to participate in the study, including two-year follow-up
• Controls will be selected using the same criteria with the exception that upon screening, they are not deemed to be at high risk for stroke.

You may not qualify if:

• Presence of established dementia
• Inability to participate in physical and exercise programs due to preexisting disability
• Illiteracy
• Prior carotid procedure altering ultrasound finding
• Presence of medical condition precluding participation or follow-up over a two-year period of time.

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• Wisconsin Partnership Program: collaborator

Study Sites (2)

University of Wisconsin-Madison

Madison, Wisconsin, 53792, United States

Location

Oneida Comprehensive Health Division

Oneida, Wisconsin, 54155, United States

Location

Related Publications (38)

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Related Links

• The Oneida Stroke Prevention Program

MeSH Terms

Conditions

Stroke; Atherosclerosis

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases

Study Officials

• Robert Dempsey, MD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2020
• First Posted: May 11, 2020
• Study Start: April 14, 2021
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: December 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)