STEPs to Blood Pressure Reduction. A Randomized Clinical Trial of the Stroke Transitions, Education, and Prevention Clinic Versus Usual Care for Post-Stroke Blood Pressure Reduction
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 115
- 试验地点
- 1
- 主要终点
- Daytime ambulatory systolic blood pressure
研究概览
简要总结
The Stroke Transitions Education and Prevention (STEP) Clinic is a new type of clinic designed for stroke patients and was established to provide a comprehensive approach to stroke risk factor reduction. The goal of this study will be more effective than usual care at reducing blood pressure in patients with poorly controlled blood pressure after an ischemic or hemorrhagic stroke or transient ischemic attack.
详细描述
STEP clinic patients will receive personalized goals, instructions to self-monitor, a blood pressure monitor, prescription medications, sleep apnea screening, dietary counseling, and more frequent follow-up if needed. A stroke neurologist will see patients in the usual care group and recommendations will be sent to their primary care providers.
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
- None
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
- •Clinical ischemic stroke, intracerebral hemorrhage, or transient ischemic attack
- •Plan to discharge home or to short stay inpatient rehab after stroke
- •Two of following required:
- •History of hypertension (prior to hospitalization)
- •Hospital blood pressure ≥ 140/90 on two or more occasions during hospitalization
- •Discharge home on blood pressure medication
- •Willingness and ability to follow-up in University of Texas Physicians stroke clinic
排除标准
- •Modified Rankin scale (mRs) > 3 at enrollment
- •Terminal illness
- •Chronic kidney disease stage 4 or greater (eGFR < 30)
- •Pregnancy
- •Symptomatic flow limiting carotid stenosis without plan for intervention prior to clinic visit
- •Stroke etiology presumed unrelated to atherosclerotic risk factors (amyloid angiopathy, vasculitis, malignancy associated)
研究组 & 干预措施
STEP Clinic
干预措施: STEP Clinic (Behavioral)
Usual Care
干预措施: Usual Care (Behavioral)
结局指标
主要结局
Daytime ambulatory systolic blood pressure
时间窗: 6 months
次要结局
- Daytime ambulatory diastolic blood pressure(6 months)
- Number of patient monitoring blood pressure at home(6 months)
- Number of patients achieving blood pressure control at 6 months as assessed by ambulatory blood pressure(6 months)
- Number of patients achieving blood pressure control at 6 months as assessed by automated office blood pressure(6 months)
- Nighttime ambulatory systolic blood pressure(6 months)
- Nighttime ambulatory diastolic c blood pressure(6 months)
- Depressive Symptoms as assessed by Patient Health Questionnaire 9(6 months)
- Satisfactions with stroke clinic as assessed by Consumer Assessment of Healthcare Providers and Systems Survey(6 months)
- Number of participants who are adherent to blood pressure medications(6 months)
- Satisfaction with Social Roles and activities as measured by NeuroQuality of Life short form(6 months)
- Self Efficacy as Assessed by Medication Adherence Self-Efficacy Scale(6 months)
- Number of composite cardiovascular events(6 months)
研究者
Anjail Z Sharrief
Assistant Professor of Neurology
The University of Texas Health Science Center, Houston