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CDP 09-414 – HSR Study

CDP 09-414
Reducing Risk of Recurrences: Issues in Maintenance and Stability in Stroke (CDA 08-009)
Jennifer P Friedberg, PhD
VA NY Harbor Healthcare System, New York, NY
New York, NY
Funding Period: April 2010 - March 2014
Patients who survive a first stroke or transient ischemic attack (TIA) remain at risk for future cerebrovascular as well as coronary events. Patients with recurrent stroke face a mortality rate of 1.8 times that of those with a first stroke, as well as a high risk of disability. Uncontrolled blood pressure (BP) and cholesterol significantly increase the risk of stroke recurrence, and there is strong evidence that secondary prevention strategies such as BP and cholesterol-lowering treatments significantly reduce the incidence of recurrent stroke. Despite the benefits of secondary stroke prevention, many patients do not reach BP and cholesterol targets, in large part due to lack of adherence to treatment recommendations. Even in patients who successfully change their behavior to adhere to diet, medication, and exercise recommendations, long-term maintenance of health behavior changes is difficult to sustain.

Among veterans with a history of stroke or TIA who have completed 6 months of a clinical trial, we will determine whether booster telephone-delivered intervention (TI) sessions lead to sustained behavioral change compared to an attention placebo (AP). The primary objective is to evaluate if improvements in BP control and sodium intake are found, while the secondary objective is to assess if improvements in total cholesterol/high density lipoprotein ratio, medication adherence, and exercise adherence are noted.

Prior to enrollment in this study, one arm will have received 6 months of a telephone-delivered tailored intervention (TI) that is followed after enrollment by two booster TI sessions at 8 and 10 months. The TI is based on the Transtheoretical Model and focuses on diet, medication, and exercise. The second arm will have received 6 months of an attention placebo (AP), which entails standard education about prevention of health conditions that are not related to cardiovascular disease or stroke (a different health topic will be discussed in each call), followed after enrollment by two booster AP sessions at 8 and 10 months. BP (6 measures taken at least 5 min apart) and dietary sodium are the primary outcomes, while secondary outcomes will be total cholesterol/high density lipoprotein ratio, adherence to antihypertensive and lipid-lowering drugs, and exercise adherence. The long-term effectiveness of booster sessions will be analyzed in an "intention to treat" manner using longitudinal methods.

The study started enrolling participants who completed their participation in a 6-month-long clinical trial in January 2010. Since this is a blinded study and enrollment is ongoing, the research team has not analyzed any outcome data yet. Thus, no results are available.

If successful, this project would provide justification for using booster counseling sessions to improve maintenance of behavior changes in patients with a history of stroke or TIA as well as in patients with other chronic health conditions where adherence is difficult to sustain.

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None at this time.

DRA: Aging, Older Veterans' Health and Care, Brain and Spinal Cord Injuries and Disorders, Cardiovascular Disease
DRE: Prevention, Prognosis, Treatment - Comparative Effectiveness, Diagnosis
Keywords: Stroke
MeSH Terms: none

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