Trial of a Secondary Stroke Prevention Program
|ClinicalTrials.gov Identifier: NCT01071408|
Recruitment Status : Completed
First Posted : February 19, 2010
Last Update Posted : May 16, 2012
|Condition or disease||Intervention/treatment||Phase|
|Ischemic Stroke Transient Ischemic Attack||Other: Stroke prevention care program||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||54 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||Development of a Stroke Prevention Program for an Underserved Minority Community|
|Study Start Date :||March 2010|
|Actual Primary Completion Date :||May 2012|
|Actual Study Completion Date :||May 2012|
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.
|No Intervention: Usual care|
- Blood pressure control [ Time Frame: baseline, 3 months, 7 months ]
- control of other stroke risk factors including lipids, smoking, and exercise [ Time Frame: baseline, 3 months, 7 months ]
- patient perceptions of care quality [ Time Frame: baseline, 3 months, 7 months ]
- medication adherence [ Time Frame: baseline, 3 months, 7 months ]
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01071408
|United States, California|
|VA Long Beach Health Care System|
|Long Beach, California, United States, 90822|
|Principal Investigator:||Eric M Cheng, MD, MS||VA Long Beach Healthcare System|