NCT01020851

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

The PREVENTS Trial: The Preventing Recurrent Events in Veterans Navigating TIA or Stroke Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 202 (estimated)
• Sponsor: Narrows Institute for Biomedical Research · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Stroke
• Transient Ischemic Attack

Interventions

Type	Name	Description
BEHAVIORAL	tailored intervention	6 monthly telephone calls focusing on diet, medication and exercise adherence using the framework of the transtheoretical model
BEHAVIORAL	attention placebo	6 monthly telephone-delivered sessions focusing on general health topics

Timeline

• Start date: 2008-09-01
• Primary completion: 2014-09-01
• Completion: 2014-09-01
• First posted: 2009-11-26
• Last updated: 2015-04-15

Locations

1 site across 1 country: United States