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Completed

NCT Number: NCT01020851

The PREVENTS Trial: The Preventing Recurrent Events in Veterans Navigating Transient Ischemic Attack (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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA New York Harbor Healthcare System, NY and Brooklyn Campuses

New York, 10010, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Tailored intervention

Behavioral

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

Attention Placebo

Behavioral

6 monthly telephone-delivered sessions focusing on general health topics

Primary outcomes

  1. blood pressure

    Time frame: 6 months

Secondary outcomes

  1. cholesterol

    Time frame: 6 months

  2. dietary adherence

    Time frame: 6 months

  3. exercise adherence

    Time frame: 6 months

  4. medication adherence

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Narrows Institute for Biomedical Research

Other

Registry information

Official study title

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

Acronym: PREVENTS

Important dates

Study start
2008
Primary completion
2014
Study completion
2014
First posted
Nov 26, 2009
Registry last updated
Apr 15, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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