The PREVENTS Trial: The Preventing Recurrent Events in Veterans Navigating Transient Ischemic Attack (TIA) or Stroke Trial

Completed · Not applicable · Has a placebo group

Conditions studied: Stroke, Transient Ischemic Attack

In brief

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.

Key facts

Study ID

NCT01020851

Run by

Narrows Institute for Biomedical Research

People needed

202

Starts

2008-09-01

Expected to finish

2014-09-01

Last updated by the study team

2015-04-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Well-documented history of stroke or TIA
• Age 21 years or older
• Continuity of care in the primary care or neurology clinics, defined as at least 1 visit in either clinic during the past 1 year
• On hypertensive and/or lipid-lowering agents
• A score of >16 on the Mini-Mental Status Exam-
• Ability to exercise (assessed by time to get up and go).

You may not qualify if…

• Limited life expectancy due to a severe non-CVD related comorbid terminal illness such as cancer
• No telephone number at which patient can be reached
• Plans to relocate within the next 6 months
• Inability to communicate over the telephone due to severe cognitive impairment or aphasia

Where it is running

• VA New York Harbor Healthcare System, NY and Brooklyn Campuses — New York, New York, United States

Full record on ClinicalTrials.gov

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