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Trial of a Secondary Stroke Prevention Program

Primary Purpose

Ischemic Stroke, Transient Ischemic Attack

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Stroke prevention care program

About this trial

This is an interventional prevention trial for Ischemic Stroke focused on measuring chronic care model, stroke prevention, health services research

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

VA Long Beach Health Care System

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Stroke Prevention Program + Usual Care

Usual care

Arm 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.

Outcomes

Primary Outcome Measures

Blood pressure control

Secondary Outcome Measures

control of other stroke risk factors including lipids, smoking, and exercise

patient perceptions of care quality

medication adherence

Stroke knowledge

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.

Full Information

NCT ID

NCT01071408

First Posted

February 12, 2010

Last Updated

May 14, 2012

Sponsor

Sepulveda Research Corporation

Collaborators

National Institute of Neurological Disorders and Stroke (NINDS)

1. Study Identification

Unique Protocol Identification Number

NCT01071408

Brief Title

Trial of a Secondary Stroke Prevention Program

Official Title

Development of a Stroke Prevention Program for an Underserved Minority Community

Study Type

Interventional

2. Study Status

Record Verification Date

May 2012

Overall Recruitment Status

Completed

Study Start Date

March 2010 (undefined)

Primary Completion Date

May 2012 (Actual)

Study Completion Date

May 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sepulveda Research Corporation

Collaborators

National Institute of Neurological Disorders and Stroke (NINDS)

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Ischemic Stroke, Transient Ischemic Attack

Keywords

chronic care model, stroke prevention, health services research

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

54 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Stroke Prevention Program + Usual Care

Arm Type

Experimental

Arm Description

Arm Title

Usual care

Arm Type

No Intervention

Intervention Type

Other

Intervention Name(s)

Stroke prevention care program

Other Intervention Name(s)

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

Intervention Description

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.

Primary Outcome Measure Information:

Title

Blood pressure control

Time Frame

baseline, 3 months, 7 months

Secondary Outcome Measure Information:

Title

control of other stroke risk factors including lipids, smoking, and exercise

Time Frame

baseline, 3 months, 7 months

Title

patient perceptions of care quality

Time Frame

baseline, 3 months, 7 months

Title

medication adherence

Time Frame

baseline, 3 months, 7 months

Title

Stroke knowledge

Description

Time Frame

baseline, 3 months, 7 months

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Eric M Cheng, MD, MS

Organizational Affiliation

VA Long Beach Healthcare System

Official's Role

Principal Investigator

Facility Information:

Facility Name

VA Long Beach Health Care System

City

Long Beach

State/Province

California

ZIP/Postal Code

90822

Country

United States

12. IPD Sharing Statement

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Trial of a Secondary Stroke Prevention Program

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