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Trial of a Secondary Stroke Prevention Program

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01071408
Recruitment Status : Completed
First Posted : February 19, 2010
Last Update Posted : May 16, 2012
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Eric M. Cheng, Sepulveda Research Corporation

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

Condition or disease Intervention/treatment Phase
Ischemic Stroke Transient Ischemic Attack Other: Stroke prevention care program Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 54 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Development of a Stroke Prevention Program for an Underserved Minority Community
Study Start Date : March 2010
Actual Primary Completion Date : May 2012
Actual Study Completion Date : May 2012

Arm Intervention/treatment
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

No Intervention: Usual care

Primary Outcome Measures :
  1. Blood pressure control [ Time Frame: baseline, 3 months, 7 months ]

Secondary Outcome Measures :
  1. control of other stroke risk factors including lipids, smoking, and exercise [ Time Frame: baseline, 3 months, 7 months ]
  2. patient perceptions of care quality [ Time Frame: baseline, 3 months, 7 months ]
  3. medication adherence [ Time Frame: baseline, 3 months, 7 months ]
  4. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01071408

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United States, California
VA Long Beach Health Care System
Long Beach, California, United States, 90822
Sponsors and Collaborators
Sepulveda Research Corporation
National Institute of Neurological Disorders and Stroke (NINDS)
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Principal Investigator: Eric M Cheng, MD, MS VA Long Beach Healthcare System
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Responsible Party: Eric M. Cheng, Neurologist, Sepulveda Research Corporation Identifier: NCT01071408    
Other Study ID Numbers: K23NS058571 ( U.S. NIH Grant/Contract )
K23NS058571 ( U.S. NIH Grant/Contract )
First Posted: February 19, 2010    Key Record Dates
Last Update Posted: May 16, 2012
Last Verified: May 2012
Keywords provided by Eric M. Cheng, Sepulveda Research Corporation:
chronic care model
stroke prevention
health services research
Additional relevant MeSH terms:
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Ischemic Attack, Transient
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Ischemia