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Lifestyle Education for Stroke Prevention

N/A

Waitlist Available

Led By Robert Dempsey, MD

Research Sponsored by University of Wisconsin, Madison

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Prior carotid procedure altering ultrasound finding

Inability to participate in physical and exercise programs due to preexisting disability

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial will develop a "Stroke Awareness Team" to provide education on the severity of the problem and how to change lifestyles to avoid strokes.

Who is the study for?

This trial is for members of the Oneida Nation receiving care through the Oneida Health Council Program, who are at high risk for stroke based on their medical history and lifestyle factors like hypertension, diabetes, smoking, and BMI. They must be willing to participate in a two-year follow-up. People with dementia, certain disabilities, illiteracy or conditions that prevent full participation are excluded.

What is being tested?

The study is testing a 'Stroke Awareness Team' approach versus standard therapies. High-risk individuals will receive either intensive coaching or standard care; low-risk individuals serve as controls without additional intervention. The program includes education on stroke prevention and healthy living events.

What are the potential side effects?

Since this trial focuses on education and lifestyle coaching rather than medication or invasive procedures, side effects are minimal but may include discomfort from lifestyle changes such as increased physical activity or dietary adjustments.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I've had a procedure on my carotid artery that affects ultrasound results.

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I cannot join physical or exercise programs because of a disability I already have.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Incidence of Stroke or TIA

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

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

+8 more

Secondary study objectives

Change in Circulating Dipeptidyl Peptidase (DPPIV)

Change in Circulating Galectin3 (Gal-3)

Change in Plaque Area

+2 more

Other study objectives

Change in Serum microRNA

Compliance Rates

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

3Treatment groups

Experimental Treatment

Group I: Low risk - controlExperimental Treatment1 Intervention

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

Group II: High Risk- intense coachingExperimental Treatment1 Intervention

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

Group III: High Risk - standard careExperimental Treatment1 Intervention

0 / 2Eligibility criteria met