Trial of a Secondary Stroke Prevention Program

Ischemic Stroke Clinical Trial

Official title:

Development of a Stroke Prevention Program for an Underserved Minority Community

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01071408
• Other study ID #: K23NS058571
• Secondary ID: K23NS058571
• Status: Completed
• Phase: N/A
• First received: February 12, 2010
• Last updated: May 14, 2012
• Start date: March 2010
• Est. completion date: May 2012

Study information

• Verified date: May 2012
• Source: Sepulveda Research Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 54
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Ischemia
• Ischemic Attack, Transient
• Ischemic Stroke
• Stroke
• Transient Ischemic Attack

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.

Locations

Country	Name	City	State
United States	VA Long Beach Health Care System	Long Beach	California

Sponsors (2)

Lead Sponsor	Collaborator
Sepulveda Research Corporation	National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	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	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.	baseline, 3 months, 7 months	No