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Clinical Trials/NCT01020851
NCT01020851
Completed
Not Applicable

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

Narrows Institute for Biomedical Research1 site in 1 country202 target enrollmentSeptember 2008

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Stroke
Sponsor
Narrows Institute for Biomedical Research
Enrollment
202
Locations
1
Primary Endpoint
blood pressure
Status
Completed
Last Updated
11 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2008
End Date
September 2014
Last Updated
11 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Narrows Institute for Biomedical Research
Responsible Party
Principal Investigator
Principal Investigator

Jennifer Friedberg

Clinical Psychologist

Narrows Institute for Biomedical Research

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

blood pressure

Time Frame: 6 months

Secondary Outcomes

  • dietary adherence(6 months)
  • medication adherence(6 months)
  • exercise adherence(6 months)
  • cholesterol(6 months)

Study Sites (1)

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