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

NCT ID: NCT01020851

Last Updated: 2015-04-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 202 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-09-30
• Study Completion Date: 2014-09-30

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.

Conditions

Stroke; Transient Ischemic Attack

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

tailored intervention

Participants in this arm will receive 6 monthly telephone calls of a behaviorally tailored intervention based on the transtheoretical model.

Group Type: EXPERIMENTAL

tailored intervention

Intervention Type: BEHAVIORAL

6 monthly telephone calls focusing on diet, medication and exercise adherence using the framework of the transtheoretical model

attention placebo

Participants in this arm will receive 6 monthly telephone delivered counseling sessions about general health topics

Group Type: ACTIVE_COMPARATOR

attention placebo

Intervention Type: BEHAVIORAL

6 monthly telephone-delivered sessions focusing on general health topics

Interventions

tailored intervention

6 monthly telephone calls focusing on diet, medication and exercise adherence using the framework of the transtheoretical model

Intervention Type: BEHAVIORAL

attention placebo

6 monthly telephone-delivered sessions focusing on general health topics

Intervention Type: BEHAVIORAL

Other Intervention Names

stage-matched intervention; transtheoretical model

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Narrows Institute for Biomedical Research

OTHER

Sponsor Role: lead

Responsible Party

Jennifer Friedberg

Clinical Psychologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

VA New York Harbor Healthcare System, NY and Brooklyn Campuses

New York, New York, United States

Countries

United States

Other Identifiers

AHA0835195N

Identifier Type: -

Identifier Source: org_study_id