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临床试验/NCT04228120
NCT04228120已完成不适用

The Effects of a Self-regulation Program on Self-care Behaviour in Patients With Heart Failure: A Randomized Controlled Trial

National Yang Ming Chiao Tung University0 个研究点目标入组 82 人开始时间: 2015年1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
82
主要终点
Changes in three self-care behaviour subscale scores

研究概览

简要总结

This RCT study aims to examine the effects of a self-regulation programme on the self-care behaviour and quality of life of patients with heart failure. The following hypothesis was tested: Heart failure patients who receive the self-regulation program will report significant improvements in self-care behaviours after four weeks of the self-regulation programme. In contrast, patients in the control group showed no significant differences.

详细描述

Eight two patients with heart failure were randomly assigned into the intervention (n = 41) or control group (n = 41). The intervention group participated in a 4-week self-regulation programme, including 20 to 30 minutes of individual self-regulation education and 15 to 20 minutes of telephone follow-up twice per week for four weeks. The control group received only routine outpatient care. Self-care behaviour was measured by the Self-Care of Heart Failure Index at baseline, 4 weeks and 8 weeks after patients were enrolled. Quality of life was measure with the Minnesota Living with Heart Failure questionnaire

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
None

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • aged 20 years or older with heart failure diagnosed by a cardiologist (ICD-9:428)
  • willing to communicate and participate in this study
  • had clear consciousness

排除标准

  • a diagnosis of cancer
  • a diagnosis of mental illness including anxiety and depression
  • had cognitive impairment
  • a diagnosis of lung disease, such as asthma or chronic obstructive pulmonary disease
  • a diagnosis of renal failure

结局指标

主要结局

Changes in three self-care behaviour subscale scores

时间窗: 4 weeks and 8 weeks

Changes from baseline Self-Care of Heart Failure Index (version 6.2) with three subscales: self-care maintenance, self-care management, and self-care confidence, at 4 weeks and 8 weeks. Each subscale score ranges from 0 to 100, with higher scores indicating better self-care behaviour.

次要结局

  • Change in quality of life scores(4 weeks and 8 weeks)

研究者

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

Ai-Fu Chiou

Professor

National Yang Ming Chiao Tung University

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