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Completed

NCT Number: NCT01071408

Trial of a Secondary Stroke Prevention Program

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

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Key information

Conditions

Ischemic Stroke Brain Diseases Brain Ischemia Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Ischemic Attack, Transient Nervous System Diseases Stroke Transient Ischemic Attack Vascular Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA Long Beach Health Care System

Long Beach, California, 90822, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Stroke prevention care program

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.

Other names: group clinics, chronic care model, secondary stroke prevention program, nurse practitioner, medication algorithms

Primary outcomes

  1. Blood pressure control

    Time frame: baseline, 3 months, 7 months

Secondary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Sepulveda Research Corporation

Industry

Collaborators

  • National Institute of Neurological Disorders and Stroke (NINDS)

Registry information

Official study title

Development of a Stroke Prevention Program for an Underserved Minority Community

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Feb 19, 2010
Registry last updated
May 16, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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