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Trial of a Secondary Stroke Prevention Program

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ClinicalTrials.gov Identifier: NCT01071408
Recruitment Status : Completed
First Posted : February 19, 2010
Last Update Posted : May 16, 2012
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Eric M. Cheng, Sepulveda Research Corporation

Tracking Information
First Submitted Date  ICMJE February 12, 2010
First Posted Date  ICMJE February 19, 2010
Last Update Posted Date May 16, 2012
Study Start Date  ICMJE March 2010
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 17, 2010)
Blood pressure control [ Time Frame: baseline, 3 months, 7 months ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01071408 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 14, 2012)
  • control of other stroke risk factors including lipids, smoking, and exercise [ Time Frame: baseline, 3 months, 7 months ]
  • patient perceptions of care quality [ Time Frame: baseline, 3 months, 7 months ]
  • medication adherence [ Time Frame: 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: February 17, 2010)
  • control of other stroke risk factors including lipids, smoking, and exercise [ Time Frame: baseline, 3 months, 7 months ]
  • patient perceptions of care quality [ Time Frame: baseline, 3 months, 7 months ]
  • medication adherence [ Time Frame: baseline, 3 months, 7 months ]
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Trial of a Secondary Stroke Prevention Program
Official Title  ICMJE Development of a Stroke Prevention Program for an Underserved Minority Community
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 Type  ICMJE Interventional
Study Phase Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Ischemic Stroke
  • Transient Ischemic Attack
Intervention  ICMJE 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
Study Arms
  • 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.
    Intervention: Other: Stroke prevention care program
  • No Intervention: Usual care
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 14, 2012)
54
Original Estimated Enrollment  ICMJE
 (submitted: February 17, 2010)
160
Actual Study Completion Date May 2012
Actual Primary Completion Date May 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01071408
Other Study ID Numbers  ICMJE K23NS058571( U.S. NIH Grant/Contract )
K23NS058571 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Eric M. Cheng, Sepulveda Research Corporation
Study Sponsor  ICMJE Sepulveda Research Corporation
Collaborators  ICMJE National Institute of Neurological Disorders and Stroke (NINDS)
Investigators  ICMJE
Principal Investigator: Eric M Cheng, MD, MS VA Long Beach Healthcare System
PRS Account Sepulveda Research Corporation
Verification Date May 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP