The PREVENTS Trial: The Preventing Recurrent Events in Veterans Navigating Transient Ischemic Attack (TIA) or Stroke Trial (PREVENTS)
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|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||Phase|
|Stroke Transient Ischemic Attack||Behavioral: tailored intervention Behavioral: attention placebo||Not Applicable|
|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|
|Actual Primary Completion Date :||September 2014|
|Actual 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|