Stroke Clinical Trial
Official title:
The PREVENTS Trial: The Preventing Recurrent Events in Veterans Navigating TIA or Stroke Trial
National recommendations state that patients with a history of transient ischemic attack
(TIA) or ischemic stroke should receive hypertension treatment, including antihypertensive
medication and lifestyle modification, with a goal of reducing blood pressure (BP) to <120
mm Hg systolic BP and <80 mm Hg diastolic BP. Statin treatment and lifestyle modification is
also recommended for post-stroke and post-TIA patients with elevated cholesterol levels or a
history of stroke or TIA with an atherosclerotic cause. Despite the clear benefits of
secondary stroke prevention, there is a gap between evidence and implementation in clinical
practice. By a randomized controlled trial, the investigators will test whether a tailored,
telephone-delivered transtheoretical model-based behavioral intervention will improve
adherence to treatment in veterans with a history of TIA or stroke, thereby leading to
better control of BP and cholesterol levels, as compared to an attention placebo.
The primary specific aims of this project are to:
- determine whether a behaviorally tailored intervention (TI) can effectively lower BP
after 6 months of counseling as compared to an attention placebo (AP) in veterans with
a history of stroke or TIA
- assess whether the TI is effective in improving adherence to diet after 6 months of
counseling in veterans with a history of stroke or TIA.
Secondary aims are to
- assess whether the TI is effective in improving cholesterol levels in post-stroke
veterans after 6 months
- evaluate whether the TI is effective in improving adherence to antihypertensive and
lipid-lowering medications after 6 months of counseling in veterans with a history of
stroke or TIA
- determine whether the TI is effective in improving adherence to exercise
recommendations after 6 months.
To answer this, veterans (n=190) with a history of stroke or TIA will be randomized equally
to the TI, which will use the transtheoretical framework to provide 6 monthly counseling
phone sessions about adherence to diet, medication, and exercise recommendations, and the
AP, in which 6 monthly counseling phone sessions about non-stroke-related health topics will
be provided. Participants will make in-person visits at baseline and 6 months. BP (3
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.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention
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