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临床试验/NCT01905176
NCT01905176Unknown不适用

The Effectiveness of Multiple Nursing Interventions, for Promoting Heart Failure Self-care, on Patients' Quality of Life and Heart Failure Outcomes: A Randomized Control Trial.

Cyprus University of Technology2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2010年4月最近更新:
适应症

试验速览

阶段
不适用
入组人数
300
试验地点
2
主要终点
Change from baseline in heart failure related quality of life at 3 months

研究概览

简要总结

The current trial aims to examine the effectiveness of three different types of nursing interventions, on heart failure (HF) patients' quality of life and on HF outcomes, compared to the usual care. The interventions include promotion of self-care practices through education and support; they are either provided before discharge, post-discharge through telephone, or both.

详细描述

The current trial aims to examine the effectiveness of three different types of nursing interventions, on heart failure (HF) patients' quality of life and on HF outcomes, compared to the usual care. The interventions include promotion of self-care practices through education and support. HF patients admitted in the public hospitals of the Cyprus Republic are screened for eligibility. Consented patients who meet the inclusion criteria are recruited before their discharge, and are randomly allocated to one of the four groups of the trial. Patients of the three intervention groups receive educational intervention and support, before discharge or post-discharge through telephone, or both. Patients of the fourth group receive the usual care (control group). The patients' follow up period is 3 months. The main purpose of the study is to determine whether the combination of predischarge education/support and tele-management is more efficient in improving HF outcomes, rather than the in-person and telephonic components alone. Outcome measures include quality of life and HF events (re-admissions and death) and time to HF event.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Supportive Care
盲法
Double (Investigator, Outcomes Assessor)

入排标准

性别
All
接受健康志愿者

入选标准

  • Hospitalized adult patients with evidenced HF
  • Planned for discharge
  • NYHA class I-IV
  • Greek speaking
  • Able and willing to give informed consent

排除标准

  • Severe mental illness or severly impaired cognitive function
  • Patients that are to be transferred to nursing or rehabilitation homes
  • Patients unable to be contacted via telephone
  • Patients with active cancer
  • Patients on dialysis
  • Patients scheduled for surgery
  • Patients recently undergone surgery (up to 3 months)
  • Patients with less than 3 months life expectancy (end-stage)
  • Patients with chronic degenerative diseases

结局指标

主要结局

Change from baseline in heart failure related quality of life at 3 months

时间窗: 3 months

Measuring the difference in quality of life scores from baseline to 3 months, by using a disease specific instrument for estimating quality of life in heart failure patients

次要结局

  • Change from baseline in general health status (functioning) at 3 months(3 months)
  • Change from baseline in heart failure self-care behavior at 3 months(3 months)
  • Combined outcome of readmission or death at 3 months post discharge(3 months)
  • Change in heart failure knowledge from baseline to 3 months(3 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ekaterini Lambrinou

Assistant Professor

Cyprus University of Technology

研究点 (2)

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