Trial of a Secondary Stroke Prevention Program

Completed

Phase N/A Results N/A

Trial Description

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.

Conditions

Interventions

  • Stroke prevention care program Other
    Other Names: group clinics; chronic care model; secondary stroke prevention program; nurse practitioner; medication algorithms
    Intervention Desc: 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.
    ARM 1: Kind: Experimental
    Label: Stroke Prevention Program + Usual Care
    Description: 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.

Trial Design

  • Allocation: Randomized
  • Masking: Double Blind (Investigator, Outcomes Assessor)
  • Purpose: Prevention
  • Endpoint: Efficacy Study
  • Intervention: Single Group Assignment

Outcomes

Type Measure Time Frame Safety Issue
Primary Blood pressure control baseline, 3 months, 7 months No
Secondary control of other stroke risk factors including lipids, smoking, and exercise baseline, 3 months, 7 months No
Secondary patient perceptions of care quality baseline, 3 months, 7 months No
Secondary medication adherence baseline, 3 months, 7 months No
Secondary Stroke knowledge baseline, 3 months, 7 months No

Sponsors