Trial of a Secondary Stroke Prevention Program

May 14, 2012 updated by: Eric M. Cheng, Sepulveda Research Corporation

Development of a Stroke Prevention Program for an Underserved Minority Community

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Long Beach, California, United States, 90822
        • VA Long Beach Health Care System

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual care
Experimental: 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.
Other: 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.
Other Names:
  • group clinics
  • chronic care model
  • secondary stroke prevention program
  • nurse practitioner
  • medication algorithms

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Blood pressure control
Time Frame: baseline, 3 months, 7 months
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
Time Frame: baseline, 3 months, 7 months
baseline, 3 months, 7 months
patient perceptions of care quality
Time Frame: baseline, 3 months, 7 months
baseline, 3 months, 7 months
medication adherence
Time Frame: baseline, 3 months, 7 months
baseline, 3 months, 7 months
Stroke knowledge
Time Frame: 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.
baseline, 3 months, 7 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sepulveda Research Corporation

Collaborators

National Institute of Neurological Disorders and Stroke (NINDS)

Investigators

  • Principal Investigator: Eric M Cheng, MD, MS, VA Long Beach Healthcare System

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2010

Primary Completion (Actual)

May 1, 2012

Study Completion (Actual)

May 1, 2012

Study Registration Dates

First Submitted

February 12, 2010

First Submitted That Met QC Criteria

February 17, 2010

First Posted (Estimate)

February 19, 2010

Study Record Updates

Last Update Posted (Estimate)

May 16, 2012

Last Update Submitted That Met QC Criteria

May 14, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K23NS058571 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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