Trial of a Secondary Stroke Prevention Program

Study Overview
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Brief Summary
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The purpose of this study is to determine whether an outpatient program can reduce the risk of recurrent stroke.

Detailed Description
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Stroke is a major cause of death and disability. A history of stroke is the strongest predictor of a future stroke. Control of risk factors lowers the risk of future stroke, yet most persons with stroke do not have their risk factors controlled. In this randomized-controlled trial, we will test whether an outpatient stroke prevention program consisting of group clinics, patient self-management, and telephone care coordination can lower the risk of recurrent stroke by improving patient knowledge, medication adherence, and lifestyle habits. If successful, this program may be adapted to other settings.

Official Title
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Development of a Stroke Prevention Program for an Underserved Minority Community

Conditions
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Ischemic Stroke, Transient Ischemic Attack

Intervention / Treatment
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* Other: Stroke prevention care program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ischemic stroke within the past 30 days transient ischemic attack within the past 30 days person receiving care at VA Long Beach Healthcare System Exclusion Criteria: unable to understand informed consent already enrolled in another research study
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stroke Prevention Program + Usual Care<br>Stroke Prevention Care Program + Usual Care. The Stroke prevention care program is in addition, not a substitute for usual care. Persons randomized to this arm are eligible to all care, including care by stroke specialists, while enrolled in the intervention. | Other: Stroke prevention care program<br>* Stroke prevention care program consists of group clinics, telephone coordination of care, and tracking of care through registries in the first 7 months after stroke or TIA presentation. A nurse practitioner will follow algorithms to adjust medications and to motivate patients to improve lifestyle habits.<br>* Other names: medication algorithms;|
| No Intervention: Usual care<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure control |  | baseline, 3 months, 7 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| control of other stroke risk factors including lipids, smoking, and exercise |  | baseline, 3 months, 7 months | 
| patient perceptions of care quality |  | baseline, 3 months, 7 months | 
| medication adherence |  | baseline, 3 months, 7 months | 
| Stroke knowledge | Open ended questions about the warning signs about stroke. Open ended questions about the risk factors of stroke. These questions evaluate the effectiveness of the didactic portion of the group sessions. | baseline, 3 months, 7 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic care model, stroke prevention, health services research