Lifestyle Education for Stroke Prevention

Not currently recruiting at 1 trial location

Overseen By Carol Mitchell, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Wisconsin, Madison

Disqualifiers: Dementia, Disability, Illiteracy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to prevent strokes by educating people about healthy living and recognizing stroke signs. Participants will be divided into groups: those at high risk will receive either standard care or intensive coaching, while a lower-risk group will serve as a control. It suits individuals who are part of the Oneida Health Council Program, are at high risk for stroke based on their health history, and are willing to stay involved for two years. The study focuses on lifestyle changes to reduce stroke risk, especially for those with conditions like high blood pressure, diabetes, or a smoking habit. As an unphased trial, this study offers participants the chance to contribute to important research that could lead to better stroke prevention strategies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems to focus on lifestyle education rather than medication changes.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that lifestyle coaching safely helps people reduce their risk of stroke. Research indicates that educational programs designed to prevent strokes are effective and harmless. For example, one study found that these health education programs can lower the chances of having another stroke and improve patients' quality of life.

Additionally, researchers have studied telehealth coaching for its safety and effectiveness. It helps stroke survivors manage their lifestyle and control risk factors without major side effects. These findings suggest that participants generally receive the intensive coaching used in this trial well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Lifestyle Education for Stroke Prevention trial because it explores how coaching and education might prevent strokes, especially in high-risk individuals. Unlike typical treatments that focus on medication to manage risk factors like hypertension and diabetes, this trial looks at intensive coaching as a way to encourage lifestyle changes. The intensive coaching arm offers personalized guidance, which could lead to significant improvements in health behaviors. By comparing different levels of intervention, researchers hope to discover if coaching can effectively reduce stroke risk compared to standard care and no intervention.

What evidence suggests that this trial's treatments could be effective for stroke prevention?

Research has shown that intensive coaching on lifestyle changes can help prevent strokes. In this trial, participants at high risk will be divided into two groups: one receiving intensive coaching and the other receiving standard care. Studies have found that health and wellness coaching can lower the risk of heart-related diseases, including stroke, over time. Programs that teach lifestyle changes, such as improving diet and increasing exercise, are among the best ways to prevent additional strokes. Evidence supports that these programs help manage risk factors like high blood pressure, diabetes, and obesity, which are major causes of stroke. Therefore, joining intensive coaching could be a helpful step in reducing stroke risk for people at high risk. ^{3 5 6 7 8}

Who Is on the Research Team?

Robert Dempsey, MD

Principal Investigator

University of Wisconsin, Madison

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Willingness to participate in the study, including two-year follow-up

I meet the study criteria but am not at high risk for stroke.

You are currently receiving healthcare through the Oneida Health Council Program.

Exclusion Criteria

You are unable to read or write.

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

You have been diagnosed with dementia.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo baseline assessments including ultrasound measurements and biomarker analysis

1-2 weeks

1 visit (in-person)

Intervention

Participants receive either standard care or intensive coaching based on American Heart Association Guidelines

2 years

Quarterly visits (in-person)

Follow-up

Participants are monitored for adherence to the program, atherosclerotic plaque progression, and incidence of stroke and TIA

2 years

What Are the Treatments Tested in This Trial?

Interventions

• High Risk - intensive coaching
• High Risk - standard care
• Low Risk - control

Trial Overview 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.

How Is the Trial Designed?

Group I: Low risk - control Experimental Treatment 1 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 coaching Experimental Treatment 1 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 care Experimental Treatment 1 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

Who Is Running the Clinical Trial?

University of Wisconsin, Madison

Lead Sponsor

Trials

1,249

Recruited

3,255,000+

Wisconsin Partnership Program

Collaborator

Trials

9

Recruited

590+

Published Research Related to This Trial

Recurrent strokes account for 23% of nearly 800,000 annual strokes, leading to higher risks of disability and mortality, highlighting the critical need for effective secondary stroke prevention strategies.

Modifiable risk factors such as diet, physical activity, smoking cessation, and alcohol consumption can significantly reduce stroke risk, and while lifestyle changes can be challenging for stroke survivors, targeted interventions and support can facilitate these modifications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lifestyle Modification for Secondary Stroke Prevention. Bailey, RR.[2023]

The Stroke Coach telehealth program did not significantly improve overall lifestyle behaviors among stroke survivors, as measured by the Health Promoting Lifestyle Profile II.

However, participants in the Stroke Coach group showed significant improvements in glucose control (HbA1c levels) and health-related quality of life (HRQoL) after 6 months, with these benefits maintained at the 12-month follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Telehealth coaching to improve self-management for secondary prevention after stroke: A randomized controlled trial of Stroke Coach. Sakakibara, BM., Lear, SA., Barr, SI., et al.[2022]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11540802/

Exploring Education Interventions for Stroke Prevention ... This investigation aims to conduct a comprehensive review of educational interventions targeting stroke prevention to provide effective preventive measures.

2. ahajournals.org ahajournals.org/doi/10.1161/STROKEAHA.124.045888?doi=10.1161/STROKEAHA.124.045888

Interventions That Support Lifestyle Behavior Change for ... In this review, we aimed to synthesize the evidence for lifestyle behavior change interventions among patients living with stroke or transient ischemic attack.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10972452/

Updated Perspectives on Lifestyle Interventions as ... This review underlines the benefits of adhering to lifestyle modifications as the most effective secondary stroke prevention measure.

4. researchprotocols.org researchprotocols.org/2023/1/e51178/

Effectiveness of a Health Education Program for Patients ... The results of this study will provide insights into the importance of health education for (self)-management and prevention of stroke.

5. neurology.org neurology.org/doi/10.1212/CPJ.0000000000200220

Health and Wellness Coaching for 5-Year Projected ... Health and wellness coaching resulted in a significant RRR in the 5-year CVD risk compared with UC at 9 months post-randomization in patients with a high ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12102088/

Lifestyle Knowledge and Behavior Among Stroke and High ... Lifestyle knowledge and behavior among stroke and high-risk younger adult patients through sex, age and stroke status differences: a cross-sectional study.

7. ahajournals.org ahajournals.org/doi/10.1161/strokeaha.111.000396

Education Strategies for Stroke Prevention The Stroke Health and Risk Education study is an educational intervention study aimed at primary stroke prevention for Mexican Americans and ...

8. researchgate.net researchgate.net/publication/351364176_EXPRESS_Telehealth_coaching_to_improve_self-management_for_secondary_prevention_after_stroke_A_randomized_controlled_trial_of_Stroke_Coach

(PDF) EXPRESS: Telehealth coaching to improve self ... Aims: To examine the efficacy of Stroke Coach on lifestyle behaviour and risk factor control among community-living stroke survivors within one-year post stroke ...