Trial of a Secondary Stroke Prevention Program

NCT ID: NCT01071408

Last Updated: 2012-05-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-03-31

Study Completion Date

2012-05-31

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.

Conditions

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Ischemic Stroke Transient Ischemic Attack

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Stroke Prevention Program + Usual Care

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.

Group Type EXPERIMENTAL

Stroke prevention care program

Intervention Type OTHER

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.

Usual care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Stroke prevention care program

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.

Intervention Type OTHER

Other Intervention Names

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group clinics chronic care model secondary stroke prevention program nurse practitioner medication algorithms

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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Neurological Disorders and Stroke (NINDS)

NIH

Sponsor Role collaborator

Sepulveda Research Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Eric M. Cheng

Neurologist

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eric M Cheng, MD, MS

Role: PRINCIPAL_INVESTIGATOR

VA Long Beach Healthcare System

Locations

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VA Long Beach Health Care System

Long Beach, California, United States

Site Status

Countries

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United States

Other Identifiers

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K23NS058571

Identifier Type: NIH

Identifier Source: secondary_id

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K23NS058571

Identifier Type: NIH

Identifier Source: org_study_id

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