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临床试验/NCT01239667
NCT01239667Unknown不适用

Rehabilitative Care to Patients With Heart Failure

University College Absalon2 个研究点 分布在 1 个国家目标入组 194 人开始时间: 2010年9月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
194
试验地点
2
主要终点
Health related quality of life

研究概览

简要总结

Hypothesis and objectives of the study Systematic preparation of rehabilitation plan for rehabilitation in Phase III based on identification of self-care behavior patients with heart failure in NYHA class II and III, leading to patients' self-care behaviors strengthened, which will result in increased health status and ADL level 6 months after discharge from hospital with heart failure .

Target

  1. To develop evidence-based clinical guidelines for patient rehabilitation phase III
  2. To test the effect of individual rehabilitation plans based on clinical guidelines for patient rehabilitation in Phase III. Efficacy evaluated in relation to changes in self-care behaviors, health status and ADL function.

Material and Methods:

Controlled longitudinal study. Each intervention patient receives before the end of hospital rehabilitation designed a specific rehabilitation plan also contacted the patient by specially trained nurse telephone 4 and 12 weeks after completion of their rehabilitation in hospital and the patient has the opportunity to contact the department when needed. The effect of rehabilitation assessed by sending questionnaires SF 36 and EHFScB Scale 9, to assess patients' ADL functioning, self-care behaviors and self-rated health.

All patients participating in the planned rehabilitation in hospitals, so that the baseline is the end of Phase II. Intervention based on an analysis of the individual's need for continued rehabilitation (self care behavior, health status, ADL function) and the patient's perception of own situation. Draw up a plan and program together with the patient

详细描述

Rehabilitation for people with serious illness, has been in focus over the last 10-15 years which is also valid for heart field (1). The focus of cardiac rehabilitation has been on the efficacy of treatment in relation to mortality, morbidity and health-related quality of life (HRQoL).

Purpose of rehabilitation are:

"Rehabilitation is a targeted and time-bound collaborative process between an individual, relatives and professionals. The aim is that citizens who have or are at risk of significant limitations in physical, mental and / or social functioning, achieve an independent and meaningful life. Rehabilitation based on the citizen's whole life situation and decisions made by a coordinated, coherent, knowledge-based action (1).

Background. Worldwide, estimated that around. 50 million people suffer from heart disease (2). In Denmark assumed that 60,000 people live with chronic heart failure, with prevalence increasing with increasing age (3) (4). In 2005 there were 142,245 hospitalizations with cardiovascular disease in Denmark, by 86,336 people, 1,786 per 100,000 men and 1,409 per 100,000 women. Viewed in isolation on heart-related deaths in the period 1998 -2005 is a decrease in mortality in general, and in 30 day mortality after AMI decreased from 10 to 4% (5). Cardiac rehabilitation has been made in traditional hospital setting and there is a documented effect of effort in terms of patients' physical function, decrease in relapse of disease, and decrease in morbidity and mortality (2) (6) (7) (8) (9).

Hypothesis and objectives of the study Hypothesis: Systematic preparation of rehabilitation plan in Phase III based on the identification of self care behavior patients with heart failure in NYHA class II and III, leading to patients' self-care behaviors strengthened, which will result in improved health status and ADL level 6 months after discharge from hospital with heart failure .

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Supportive Care
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

  • Patients who are 18 years or older and valued at NYHA II and III are included in the study. -

排除标准

  • Patients who do not wish to participate. Patients with language and communication impedes Sufficient participation. Patients who do not understand information, as well as patients diagnosed with neurological deficits.

结局指标

主要结局

Health related quality of life

时间窗: Measured 6 month after discharge from hospital

Evidence for health related quality of life in heart failure patients in the rehabilitation phase, measured with instrument SF 36

Self Care Behavior

时间窗: measured 6 month after discharge

Mesure the patients self care behavior by using the instrument European Heart Failure Self Care Behavior Scale

Activities of Daily Living

时间窗: 6 month after discharge

measure the patients PADL and IADL functions

次要结局

未报告次要终点

研究者

发起方
University College Absalon
申办方类型
Other

研究点 (2)

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