Center for Stroke Disparities Solution (CSDS) Project II: Community Transitions Intervention (CTI)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 495
- 试验地点
- 1
- 主要终点
- Reduction of systolic blood pressure
研究概览
简要总结
The Stroke CTI study is a 3 arm randomized, controlled trial designed to assess the effectiveness of a nurse practitioner (NP) only and a NP and health coach (HC) community transitions intervention (CTI) in reducing secondary stroke risk by helping patients lower their systolic blood pressure.
详细描述
Targeted study participants are Black and Hispanic patients with a history of stroke and a current systolic blood pressure (BP) above JNC7 recommended range (>=140 mmHg) who recently entered home care service. The NP only program will provide a 30 day intervention while the NP/HC team will provide 3 months of support via in-home and telephone encounters for patients randomized to one of these groups. In the first 30 days post-enrollment the NP will focus on medical case management and coordination with primary care providers and specialists, provide self-management coaching, and intervene if gaps in care are identified - all with a focus on BP reduction and preparing the patient for ongoing BP maintenance. As applicable, the HC will pick up the case after 30 days and follow up with the plan of care jointly established by the patient, NP and HC. The focus will be on ongoing self-management coaching, providing preparation support for physician visits, and linking patient to additional community resources, as needed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 21 Years 至 —(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly admitted to the VNSNY post acute care program
- •21 years of age or older
- •Black and/or Hispanic
- •Speaks English or Spanish
- •History of stroke or transient ischemic attack (TIA)
- •Hypertension diagnosis
- •Average screening systolic BP >= 140 mmHg
- •Is available to participate in intervention activities during the study timeframe if randomized to treatment group
排除标准
- •End stage renal disease
- •Kidney transplant
- •Severe heart failure
- •Significant cognitive impairment. Unable to provide informed consent, accurate self-report, and/or unable to participate effectively in intervention
- •Significant verbal speech impairment. Unable to participate in intervention telephone sessions
- •Patients with upper arm circumference outside of valid use parameters for the automated device used for eligibility screening
结局指标
主要结局
Reduction of systolic blood pressure
时间窗: Baseline to 3 and 12 months.
Patients randomized to the NP only and the NP+HC transitional care interventions will have greater 3 and 12 month reduction in SBP than patients in Usual Home Care.
次要结局
- Influence on post-stroke patients' function and health-related quality of life (QoL)(Baseline to 3 and 12 months)
- Cost-effectiveness of NP-only and NP+HC relative to UHC(VNSNY home care admission to 3 and 12 months post admission)
