Family Focused Nursing for Outpatients With Heart Failure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 468
- 试验地点
- 6
- 主要终点
- Change in Health Related Quality of Life assessed by ≥6 point in Kansas City Cardiomyopathy Questionnaire summary score
研究概览
简要总结
The purpose of this study is to determine whether Family Focused Nursing are effective in the treatment of heart failure outpatients with respect to health-related quality of life.
详细描述
Quality of life is impaired among patients with heart failure and their next of kin compared to other patients with chronic diseases. Besides, there are still a number of patients who misunderstand or have difficulties remembering the counseling they are provided during the course of illness. International guidelines recommend that the patient's relatives are involved in patient education as well as the treatment. Family interventions might contribute to improvement in quality of life, enhanced illness-management and delayed readmission and mortality among patients with heart failure. However, up till today, only two observational studies have investigated the effect of family intervention on outcomes of treatment for heart failure.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Referred to follow-up nursing treatment in nurse-led heart failure clinic
- •Diagnosed chronic heart failure, based on systolic dysfunction (left ventricular ejection fraction (LVEF) ≤40%)
- •New York Heart Association (NYHA) classification II-IV symptoms
- •Signed informed consent
排除标准
- •Patients not understanding or talking danish
- •In terminal phase of another serious illness such as i.e. cancer with expected lifetime less than 6 months
- •Patients not giving informed consent
结局指标
主要结局
Change in Health Related Quality of Life assessed by ≥6 point in Kansas City Cardiomyopathy Questionnaire summary score
时间窗: Baseline, three, six and twelve months
The effect of intervention on primary outcome are investigated as longitudinal data at three, six and twelve month. The data are analysed using mixed models
次要结局
- Change in European Heart Failure Self-Care Behavior Scale(Baseline, three, six and twelve months months)
- Change in Family Functioning, Health and Social Support scale(Baseline, three, six and tvelve months)
- Change in Self-Efficacy for Managing Chronic Disease 6-item scale(Baseline, three, six and tvelve months)
- Change in Major Depression Inventory diagnostic scale(Baseline, three, six and tvelve months)
- Time for the emergence of mortality(One year)
- Time for the emergence of total re-admission and re-admission for heart failure(One year)
研究者
Birte Oestergaard
Associate professor
University of Southern Denmark