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

Not Applicable

Completed

• Conditions: Stroke; Transient Ischemic Attack
• Interventions: Behavioral: attention placebo; Behavioral: tailored intervention

• Registration Number: NCT01020851
• Lead Sponsor: Narrows Institute for Biomedical Research

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-09
• Study First Submitted: 2009-11-25
• Study First Submitted QC: 2009-11-25
• Study First Posted: 2009-11-26
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-14
• Last Update Posted: 2015-04-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 202

Inclusion Criteria

• 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).

Exclusion Criteria

• 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

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
attention placebo	attention placebo	Participants in this arm will receive 6 monthly telephone delivered counseling sessions about general health topics
tailored intervention	tailored intervention	Participants in this arm will receive 6 monthly telephone calls of a behaviorally tailored intervention based on the transtheoretical model.

Primary Outcome Measures

Name	Time	Method
blood pressure	6 months

Secondary Outcome Measures

Name	Time	Method
dietary adherence	6 months
medication adherence	6 months
exercise adherence	6 months
cholesterol	6 months

Trial Locations

Locations (1)

VA New York Harbor Healthcare System, NY and Brooklyn Campuses; 🇺🇸 New York, New York, United States