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

NCT01020851 | Completed

• 1 other identifier: AHA0835195N
• Study Type: interventional
• Target: 202
• Locations: 1 country
• Sites: 1

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

Keywords

hypertension; stroke; cholesterol; adherence

Outcome Measures

Primary Outcomes (1)

• blood pressure

  6 months

Secondary Outcomes (4)

• cholesterol

  6 months

• dietary adherence

  6 months

• exercise adherence

  6 months

• medication adherence

  6 months

Study Arms (2)

tailored intervention

EXPERIMENTAL

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

Behavioral: tailored intervention

attention placebo

ACTIVE COMPARATOR

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

Behavioral: attention placebo

Interventions

tailored intervention BEHAVIORAL

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

Also known as: stage-matched intervention, transtheoretical model

tailored intervention

attention placebo BEHAVIORAL

6 monthly telephone-delivered sessions focusing on general health topics

attention placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Narrows Institute for Biomedical Research: lead

Study Sites (1)

VA New York Harbor Healthcare System, NY and Brooklyn Campuses

New York, New York, 10010, United States

Location

MeSH Terms

Conditions

Stroke; Ischemic Attack, Transient; Hypertension

Interventions

Transtheoretical Model

Condition Hierarchy (Ancestors)

Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Brain Ischemia

Intervention Hierarchy (Ancestors)

Health Belief Model; Models, Theoretical; Investigative Techniques; Models, Psychological

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Psychologist

Study Record Dates

• First Submitted: November 25, 2009
• First Posted: November 26, 2009
• Study Start: September 1, 2008
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: April 15, 2015

Record last verified: 2015-04

Locations

US (1)