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临床试验/NCT01918891
NCT01918891已完成不适用

Center for Stroke Disparities Solution (CSDS) Project II: Community Transitions Intervention (CTI)

Visiting Nurse Service of New York1 个研究点 分布在 1 个国家目标入组 495 人开始时间: 2012年9月最近更新:
适应症

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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