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临床试验/NCT01020851
NCT01020851已完成不适用

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

Narrows Institute for Biomedical Research2 个研究点 分布在 1 个国家目标入组 202 人开始时间: 2008年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
202
试验地点
2
主要终点
blood pressure

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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).

排除标准

  • 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

结局指标

主要结局

blood pressure

时间窗: 6 months

次要结局

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

研究者

发起方
Narrows Institute for Biomedical Research
申办方类型
Other
责任方
Principal Investigator
主要研究者

Jennifer Friedberg

Clinical Psychologist

Narrows Institute for Biomedical Research

研究点 (2)

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