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Trial of a Secondary Stroke Prevention Program

This study has been completed.
Sponsor:
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Eric M. Cheng, Sepulveda Research Corporation
ClinicalTrials.gov Identifier:
NCT01071408
First received: February 12, 2010
Last updated: May 14, 2012
Last verified: May 2012
History of Changes
  Purpose

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


Condition Intervention
Ischemic Stroke
Transient Ischemic Attack
 Other: Stroke prevention care program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Development of a Stroke Prevention Program for an Underserved Minority Community

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sepulveda Research Corporation:

Primary Outcome Measures:
  • Blood pressure control [ Time Frame: baseline, 3 months, 7 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • control of other stroke risk factors including lipids, smoking, and exercise [ Time Frame: baseline, 3 months, 7 months ] [ Designated as safety issue: No ]
  • patient perceptions of care quality [ Time Frame: baseline, 3 months, 7 months ] [ Designated as safety issue: No ]
  • medication adherence [ Time Frame: baseline, 3 months, 7 months ] [ Designated as safety issue: No ]
  • Stroke knowledge [ Time Frame: baseline, 3 months, 7 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 54
Study Start Date: March 2010
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01071408

Locations
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)
Investigators
Principal Investigator: Eric M Cheng, MD, MS VA Long Beach Healthcare System
  More Information

No publications provided

Responsible Party: Eric M. Cheng, Neurologist, Sepulveda Research Corporation
ClinicalTrials.gov Identifier: NCT01071408     History of Changes
Other Study ID Numbers: K23NS058571, K23NS058571
Study First Received: February 12, 2010
Last Updated: May 14, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Sepulveda Research Corporation:
chronic care model
stroke prevention
health services research

Additional relevant MeSH terms:
Ischemic Attack, Transient
Ischemia
Stroke
Cerebral Infarction
Brain Ischemia
Cerebrovascular Disorders
Brain Diseases
 Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction

ClinicalTrials.gov processed this record on May 22, 2013