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

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

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.

Study Overview

• Status: Completed
• Conditions: Stroke; Transient Ischemic Attack
• Intervention / Treatment: Behavioral: tailored intervention; Behavioral: attention placebo

• Study Type: Interventional
• Enrollment (Anticipated): 202
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10010
      • VA New York Harbor Healthcare System, NY and Brooklyn Campuses

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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; Other Names: stage-matched intervention; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
blood pressure	6 months

Secondary Outcome Measures

Outcome Measure	Time Frame
medication adherence	6 months
exercise adherence	6 months
cholesterol	6 months
dietary adherence	6 months

Collaborators and Investigators

• Sponsor: Narrows Institute for Biomedical Research

Study record dates

Study Major Dates

• Study Start: September 1, 2008
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: November 25, 2009
• First Submitted That Met QC Criteria: November 25, 2009
• First Posted (Estimate): November 26, 2009

Study Record Updates

• Last Update Posted (Estimate): April 15, 2015
• Last Update Submitted That Met QC Criteria: April 14, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: stroke; adherence; hypertension; cholesterol
• Additional Relevant MeSH Terms: Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Brain Ischemia; Stroke; Ischemia; Ischemic Attack, Transient
• Other Study ID Numbers: AHA0835195N