Lifestyle Education for Stroke Prevention

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

120 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the treatment 'Lifestyle Education for Stroke Prevention'?

Research shows that lifestyle coaching, like the Stroke Coach program, can help people manage risk factors for stroke by improving their diet, exercise, and other habits. Programs that include education and coaching have been found to be feasible, well-received, and beneficial for health, with participants often making positive lifestyle changes. ^{1 2 3 4 5}

Is the Lifestyle Education for Stroke Prevention program safe for humans?

The Lifestyle Education for Stroke Prevention program, which includes telehealth coaching and supervised exercise, has been shown to be safe for participants, with no adverse events reported in studies. Participants found the program relevant and felt safe to exercise, with high satisfaction rates. ^{1 2 3 4 6}

How does the Lifestyle Education for Stroke Prevention treatment differ from other stroke prevention treatments?

This treatment is unique because it involves intensive coaching and lifestyle education to manage stroke risk factors, using a telehealth program called Stroke Coach. Unlike standard care, it focuses on self-management and lifestyle changes, such as diet and physical activity, to prevent recurrent strokes. ^{1 2 3 7 8}

What is the purpose of this trial?

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.

Research Team

Robert Dempsey, MD

Principal Investigator

University of Wisconsin, Madison

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Development of a Chronic Disease Management Program for Stroke Survivors Using Intervention Mapping: The Stroke Coach. [2018]

2. United States pubmed.ncbi.nlm.nih.gov

Telehealth coaching to improve self-management for secondary prevention after stroke: A randomized controlled trial of Stroke Coach. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

A telehealth intervention to promote healthy lifestyles after stroke: The Stroke Coach protocol. [2019]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Evaluating Feasibility of a Secondary Stroke Prevention Program. [2023]

5. United States pubmed.ncbi.nlm.nih.gov

Primary prevention of stroke and cardiovascular disease in the community (PREVENTS): Methodology of a health wellness coaching intervention to reduce stroke and cardiovascular disease risk, a randomized clinical trial. [2021]

6. England pubmed.ncbi.nlm.nih.gov

'Masterstroke: a pilot group stroke prevention program for community dwelling stroke survivors'. [2016]

7. United States pubmed.ncbi.nlm.nih.gov

Lifestyle Modification for Secondary Stroke Prevention. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Primary prevention of stroke by a healthy lifestyle in a high-risk group. [2018]