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临床试验/NCT00371085
NCT00371085已完成4 期

Congestive Heart Failure Outreach Program (The COPE Study)

University of Alberta2 个研究点 分布在 1 个国家目标入组 539 人开始时间: 2004年10月最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
入组人数
539
试验地点
2
主要终点
Differences in clinical outcomes, as measured by cardiovascular hospitalizations and emergency room presentations, between video-based education and usual care groups.

研究概览

简要总结

Heart failure is a very common condition and is one of the main reasons people are admitted to hospital. There are many things people with heart failure can do to manage their condition at home. Unfortunately many people do not have enough information to do this and need to come back to the hospital because their heart failure got worse. This study will look at different ways to help people learn more about heart failure and how to manage their condition at home.

详细描述

Background:

Given the clinical and economic importance of heart failure (HF) widely applicable strategies to improve patient outcomes are needed. In Canada,1.4 million hospital days were associated with HF in the fiscal year 2000 and almost one-third of these were readmissions . The majority of acute precipitants of HF relate to poor self-care including excessive sodium and fluid intake, and nonadherence to medications. Data derived from the PaKSAC survey confirm that patients with HF have very poor knowledge of their condition and self-care recommendations.

Disease Management Programs for HF have been shown to improve clinical outcomes by providing intensive education and medical management. Due to the resource intensity of such programs, however, only a limited proportion of the population at risk is served. Clearly more practical educational interventions are needed.

Hypothesis:

An intervention consisting of a video-based educational program for patients with HF, focusing on 3 key steps (salt restriction, daily weights and medication adherence) will improve knowledge of self-care activities, and clinical and economic outcomes at 6 months of follow-up.

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

  • patient in hospital or emergency room with symptomatic CHF confirmed by a physician.
  • patient seen in an outpatient clinic with symptomatic CHF confirmed by a physician, AND hospitalized within the previous 6 months for heart failure.
  • age greater than 18 years.

排除标准

  • asymptomatic CHF
  • life expectancy < 6 months
  • receiving chronic hemodialysis or peritoneal dialysis
  • unable to communicate (non-English speaking, intubated, etc)
  • demented or a mental illness which precludes participation
  • receives professional assistance for self-care activities including meals or medications (e.g. nursing home)
  • previously enrolled in this study
  • participation in another heart failure study, or
  • declined to participate

结局指标

主要结局

Differences in clinical outcomes, as measured by cardiovascular hospitalizations and emergency room presentations, between video-based education and usual care groups.

时间窗: 6 months

次要结局

  • Differences in all-cause hospitalizations between groups(6 months)
  • Differences in CHF-related hospitalizations between groups(6 months)
  • Differences in total number of in-hospital days between groups(6 months)
  • Change in CHF knowledge levels from the initial in-hospital patient contact to the end of the 6 month follow-up between the two groups(6 months)

研究者

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

Ross T. Tsuyuki

Principal Investigator

University of Alberta

研究点 (2)

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