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临床试验/NCT00211874
NCT00211874已完成不适用

Improving Heart Failure Care in Minority Communities

Icahn School of Medicine at Mount Sinai4 个研究点 分布在 1 个国家目标入组 406 人开始时间: 2000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
406
试验地点
4
主要终点
Short Form 12 questionnaire

研究概览

简要总结

For congestive heart failure (CHF) patients with systolic dysfunction, a randomized controlled trial compared nurse-based disease management to address problems in patient and clinician management with usual care for effects on hospitalization and functioning among ethnically-diverse patients in ambulatory practices.

详细描述

Congestive heart failure (CHF) disproportionately afflicts Black and elderly people, and is a leading cause of hospitalization > 65 years. Although effective therapies can improve functioning and survival in patients with systolic dysfunction, many may not be receiving the full benefit of existing knowledge, including counseling on self-management and appropriate doses of medications. Patients play a critical role in managing a chronic condition such as CHF, but may not have the skills to do so. Clinicians may not provide counseling or medications consistent with evidence-based guidelines.

Systematic reviews of clinical-behavior change have suggested that interventions targeted to specific problems are more likely to be successful. Based on shortfalls identified in patient self-management and clinical care in Harlem, a predominately non-white area in northern Manhattan, we tailored a nurse-management intervention to address the problems documented, and evaluated its effectiveness in a randomized controlled trial. This trial among primarily-minority patients addresses important gaps in this literature: the study targeted problems documented among CHF patients in Harlem, enrolled patients from ambulatory practices, randomly assigned patients between nurse-management and usual care, and evaluated their subsequent health-related outcomes. Hypothesis: the nurse-management program would result in nurse patients' having fewer hospitalizations and reporting better functioning.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
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

入选标准

  • • adults >18 years,
  • systolic dysfunction documented on a cardiac test (echocardiography, radionuclide ventriculography, myocardial stress sestamibi/thallium testing, or left-heart catheterization),
  • English- or Spanish-speaking,
  • community-dwelling at enrollment, and
  • current patient in a general medicine, geriatrics, or cardiology clinic or office at a participating site.

排除标准

  • • medical conditions that prevented a patient's interacting with the nurse, including blindness, deafness, and cognitive impairment;
  • medical conditions that required individualized management that might differ from standard protocol, namely pregnancy, renal dialysis, and terminal illness; and
  • procedures that corrected systolic dysfunction, such as heart transplantation.

结局指标

主要结局

Short Form 12 questionnaire

时间窗: 12 months

self-reported physical functioning as measured by the physical component score on the Short Form 12 questionnaire

次要结局

  • Number of hospitalizations(12 months)
  • Minnesota Living with Heart Failure Questionnaire(12 months)
  • Number of deaths(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (4)

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