Secondary Stroke Prevention by Uniting Community and Chronic Care Model Teams Early to End Disparities: the SUCCEED Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 487
- 试验地点
- 12
- 主要终点
- Systolic Blood Pressure
研究概览
简要总结
The purpose of this study is to test a newly-developed outpatient clinic and community-based care intervention called SUCCEED (Secondary stroke prevention by Uniting Community and Chronic care model teams Early to End Disparities) for improving control of stroke risk factors among stroke patients in the Los Angeles County "safety net", and to measure the costs of running such an intervention, relative to usual care.
详细描述
Individuals randomized to the intervention arm will receive care from a team that consists of a care manager(CM) who is either a nurse practitioner (NP) or physician assistant (PA), supervised by the site PI, and a community health worker (CHW). The CM will follow care protocols developed by the research team. The CHW will serve as a liaison between the patient and the health care system, and mobilize resources and system support to reduce social isolation and improve stroke risk factor control self-management, through a series of workshops and home visits. Intervention participants will receive home blood pressure monitors. Subjects in either arm are eligible to receive their usual source of care. Five hundred participants who have had a stroke or TIA will be enrolled, randomized to the intervention or to usual care in a 1:1 ratio, and followed for 12 months. The impact of the intervention on systolic blood pressure is the primary study outcome; secondary outcomes are other stroke risk factors. Enrollment will occur at four sites in Los Angeles County, and the study sample is projected to include over 90% socioeconomically disadvantaged individuals from minority groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of Los Angeles County+University of Southern California (LAC-USC), Rancho Los Amigos, Olive View-University of California, Los Angeles (UCLA), or Harbor-UCLA
- •Transient ischemic attack (TIA), ischemic stroke or hemorrhagic stroke within the prior 90 days
- •English, Spanish, Korean, Mandarin or Cantonese-speaking
- •40 years of age or older
- •Capable of giving informed consent (no proxies will be used to obtain consent)
- •Systolic blood pressure is 130 mm Hg or greater OR Systolic blood pressure is between 120 mm Hg and 130 mm Hg and there is diagnosed/treated hypertension prior to the stroke or TIA
排除标准
- •Younger than 40 years
- •Systolic Blood Pressure less than 120 mm Hg OR systolic blood pressure is between 120 mm Hg and 130 mm Hg and there is no known history of hypertension prior to the stroke or TIA
- •Speaks language other than English, Spanish, Korean, Mandarin, and Cantonese
- •Inability to comprehend the study because of communication or cognitive impairments
结局指标
主要结局
Systolic Blood Pressure
时间窗: 12 months
Blood pressure at 12 months will be the primary outcome. Blood pressure will also be measured at baseline and at the 3-month mark to track blood pressure during the entire participation period.
次要结局
- Body Mass Index(12 months)
- Dyslipidemia(12 months)
- Smoking(12 months)
- Soda Intake(12 months)
- Fruit and Vegetable Intake(12 months)
- Waist Circumference(12 months)
- Physical Activity(12 months)
- Salt Intake(12 months)
- Medication Adherence - Blood Pressure Medication(12 Months)
- Percentage of Glycated Hemoglobin (Hemoglobin A1C)(12 months)
- Inflammation: C-reactive Protein(12 months)
- Medication Adherence - Antithrombotic Medication(12 months)
- Patient Perception of Quality of Stroke Preventative Care(12 months)
- Knowledge About Stroke Signs(12 months)
- Medication Adherence - Global(12 Months)
- Medication Adherence - Cholesterol Medication(12 months)
- Knowledge About Stroke Risk Factors(12 months)
- Vascular Events(12 months)
- Medication Adherence - Antidepressant Medication(12 months)
研究者
Barbara Vickrey, MD, MPH
Principal Investigator
University of California, Los Angeles