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Clinical Trial Summary

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.


Clinical Trial Description

n/a


Study Design

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


Related Conditions & MeSH terms


NCT number NCT01020851
Study type Interventional
Source Narrows Institute for Biomedical Research
Contact
Status Completed
Phase N/A
Start date September 2008
Completion date September 2014

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