Improving Blood Pressure Control in Stroke Patients by Increasing Access to a Home Blood Pressure Monitor
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Blood pressure
研究概览
简要总结
The goal of this clinical trial is to learn whether providing teaching with a low-cost device can help to improve blood pressure, health outcomes, patient self-efficacy without exacerbating inequity between advantaged and disadvantaged patients.
The main question[s] it aims to answer are:
- Does providing a free home blood pressure cuff improve control of hypertension?
- Does providing a free home blood pressure cuff have a greater impact on control of hypertension in disadvantaged populations?
- Does improved control of home blood pressure decrease adverse patient outcomes?
Participants will be asked to
- Take their blood pressure at home and records the results
- Participate in follow-up phone calls from investigators at at 3 and 6 months
Researchers will compare patients provided with home blood pressure monitors to those who are provided with routine education
详细描述
Patients with a history of hypertension and a history stroke (ischemic or hemorrhagic), transient ischemic attack (TIA), or otherwise are at high risk of stroke will be screened for enrollment.
Inclusion and exclusion criteria will be reviewed and confirmed by a member of the study team. If the patient meets criteria, the following will occur:
A member of the study team (physician, nurse, study coordinator) will describe the study to the patient and inform them of their candidacy. If the patient indicates interest in study participation, the patient will be provided a written or electronic consent form to review and sign. The patient will be randomized to one of two arms in the study.
Upon enrollment, the patient will complete an intake survey. Prior to hospital discharge, patients randomized to arm 1 (control) of the study will receive routine stroke discharge education which is standard of care. In addition to standard of care, a stroke nurse will provide and review with the patient a short informational pamphlet (included in the attachments) on the importance of blood pressure monitoring.
Patients randomized to arm 2 (intervention) will also receive this teaching as above. In addition, they will be given an Omron Home Blood Pressure Cuff furnished by the study. The nurse will provide additional education on on how to use the cuff, and how to record values in a blood pressure log.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Patients over the age of 18 admitted to the Stanford Hospital (SHC) stroke service and discharging to home or acute rehab
- •Diagnosis of Ischemic Stroke, Hemorrhagic Stroke, transient ischemic attack (TIA), or otherwise deemed to be at increased risk of stroke by the treating team (for example, asymptomatic carotid stenosis).
- •No usable home blood pressure cuff available
- •Diagnosis of hypertension or elevated blood pressure (> 130/80) concerning to the treating clinician for hypertension
- •Participant or surrogate able to apply a home blood pressure cuff on the participant
- •Patient or Legally Authorized Representative (LAR) agree to participate and are able to consent.
排除标准
- •Currently enrolled in another blood pressure or secondary prevention interventional research study
- •Upper arm circumference > 20 inches
- •Any other reason that, in the opinion of the investigator, makes the person a poor candidate for participation in this study
结局指标
主要结局
Blood pressure
时间窗: Month 6
Home blood pressure measurements provided by patient at month 6
次要结局
- Incidence of stroke(Months 3 and 6)
- Incidence of TIA(Months 3 and 6)
- Any hospitalization(Months 3 and 6)
研究者
Christina Mijalski
Clinical Assistant Professor
Stanford University