The PREVENTS Trial: The Preventing Recurrent Events in Veterans Navigating TIA or Stroke Trial
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
- 否
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
Jennifer Friedberg
Clinical Psychologist
Narrows Institute for Biomedical Research
