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Lifestyle Education for Stroke Prevention

N/A
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights

Study 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.Check my eligibility
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.See study design
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.

Timeline

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
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 outcome measures
Change in Circulating Dipeptidyl Peptidase (DPPIV)
Change in Circulating Galectin3 (Gal-3)
Change in Plaque Area
+2 more
Other outcome measures
Change in Serum microRNA
Compliance Rates

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
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

Find a Location

Who is running the clinical trial?

University of Wisconsin, MadisonLead Sponsor
1,189 Previous Clinical Trials
3,169,426 Total Patients Enrolled
13 Trials studying Stroke
271,000 Patients Enrolled for Stroke
Wisconsin Partnership ProgramOTHER
7 Previous Clinical Trials
338 Total Patients Enrolled
Robert Dempsey, MDPrincipal InvestigatorUniversity of Wisconsin, Madison

Media Library

High Risk - intensive coaching Clinical Trial Eligibility Overview. Trial Name: NCT04382963 — N/A
Stroke Research Study Groups: Low risk - control, High Risk - standard care, High Risk- intense coaching
Stroke Clinical Trial 2023: High Risk - intensive coaching Highlights & Side Effects. Trial Name: NCT04382963 — N/A
High Risk - intensive coaching 2023 Treatment Timeline for Medical Study. Trial Name: NCT04382963 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there specific requirements for the participants of this experiment?

"To be eligible for this atherogenesis study, patients must be between 55 and 80 years old and currently enrolled in the Oneida Health Council Program. They will also undergo a modified Framingham assessment to determine if they are at high risk for stroke. If they are deemed to be at high risk, and they meet the other criteria listed below, they will be enrolled in the study. Controls for the study will be selected using the same process, with the exception that they cannot be at high risk for stroke."

Answered by AI

Does this research extend to senior citizens?

"This study allows for patients that are aged between 55 to 80 years old, as these are the minimum and maximum age limits set by the eligibility criteria."

Answered by AI

Are we still able to sign new people up for the trial?

"The most up-to-date information on clinicaltrials.gov reveals that this clinical trial is looking for participants. The trial was first advertised on April 14th 2021 and has had some updates since then, with the most recent being on May 9th, 2022."

Answered by AI
Recent research and studies
~6 spots leftby Jun 2024