Trial of a Secondary Stroke Prevention Program

Not Applicable

Completed

• Conditions: Transient Ischemic Attack; Ischemic Stroke
• Interventions: Other: Stroke prevention care program

• Registration Number: NCT01071408
• Lead Sponsor: Sepulveda Research Corporation

Brief Summary

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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2010-02-12
• Study First Submitted QC: 2010-02-17
• Study First Posted: 2010-02-19
• Study Start: 2010-03
• Status Verified: 2012-05
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Last Update Submitted: 2012-05-14
• Last Update Posted: 2012-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Stroke Prevention Program + Usual Care	Stroke prevention care program	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.

Primary Outcome Measures

Name	Time	Method
Blood pressure control	baseline, 3 months, 7 months

Secondary Outcome Measures

Name	Time	Method
Stroke knowledge	baseline, 3 months, 7 months	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.
medication adherence	baseline, 3 months, 7 months
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

Trial Locations

Locations (1)

VA Long Beach Health Care System; 🇺🇸 Long Beach, California, United States