The PREVENTS Trial: The Preventing Recurrent Events in Veterans Navigating Transient Ischemic Attack (TIA) or Stroke Trial (PREVENTS)
|ClinicalTrials.gov Identifier: NCT01020851|
Recruitment Status : Completed
First Posted : November 26, 2009
Last Update Posted : April 15, 2015
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.
|Condition or disease||Intervention/treatment|
|Stroke Transient Ischemic Attack||Behavioral: tailored intervention Behavioral: attention placebo|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||202 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||The PREVENTS Trial: The Preventing Recurrent Events in Veterans Navigating TIA or Stroke Trial|
|Study Start Date :||September 2008|
|Primary Completion Date :||September 2014|
|Study Completion Date :||September 2014|
Experimental: tailored intervention
Participants in this arm will receive 6 monthly telephone calls of a behaviorally tailored intervention based on the transtheoretical model.
Behavioral: tailored intervention
6 monthly telephone calls focusing on diet, medication and exercise adherence using the framework of the transtheoretical model
Active Comparator: attention placebo
Participants in this arm will receive 6 monthly telephone delivered counseling sessions about general health topics
Behavioral: attention placebo
6 monthly telephone-delivered sessions focusing on general health topics
- blood pressure [ Time Frame: 6 months ]
- cholesterol [ Time Frame: 6 months ]
- dietary adherence [ Time Frame: 6 months ]
- exercise adherence [ Time Frame: 6 months ]
- medication adherence [ Time Frame: 6 months ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01020851
|United States, New York|
|VA New York Harbor Healthcare System, NY and Brooklyn Campuses|
|New York, New York, United States, 10010|