CopenHeart IE - A Randomized Clinical Trial Investigating the Effect and Meaning of Integrated Rehabilitation Versus Usual Follow-up of Patients Treated for Infective Endocarditis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 117
- 试验地点
- 2
- 主要终点
- Change in Mental component scale
研究概览
简要总结
The aim of the study is to describe the effect and meaning of an integrated rehabilitation programme, consisting of physical training and psycho-educational care, for patients treated for infective endocarditis.
The hypothesis is, that integrated rehabilitation can improve mental health, physical capacity and other factors.
详细描述
Infective endocarditis (IE) is among the most serious infectious diseases in the western world. Treatment requires lengthy hospitalization, high dosage antibiotics and possible valve replacement surgery. Studies indicate that patients experience persisting physical symptoms, diminished quality of life and difficulties returning to work, up to a year post-discharge. No studies investigating the effect of, interventions aimed at relieving these problems, have been published.
A randomized clinical trial is conducted to investigate the effect and meaning of an integrated rehabilitation programme on the physical and psychosocial functioning of patients treated for IE. The trial is a multi-centre, parallel arm design. A mixed methods embedded experimental design is chosen to include both quantitative and qualitative data to evaluate the intervention. The intervention consists of five psycho-educational consultations provided by specialized nurses and a twelve week individualized exercise training programme provided by physiotherapists. A qualitative and a survey-based pre-study will be undertaken, to investigate post-discharge experiences and rehabilitation needs of patients treated for IE. A qualitative post-intervention study will explore rehabilitation participation experiences.
The hypothesis is, that integrated rehabilitation can improve mental health, physical capacity, self-rated health, quality of life, nutritional status, sleep-quality and body-image and reduce anxiety, depression, fatigue, health care utilisation, work cessation and mortality in patients treated for IE and that it is cost effective.
150 patients treated for leftsided- (native- or prosthetic valve) or cardiac device endocarditis will be included in the trial
Questionnaires, cardiopulmonary testing, 6 minute walking test and qualitative interviews will be used to evaluate the effect and meaning of the programme.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •treated for leftsided- (native- or prosthetic valve) or cardiac device endocarditis based on Duke Criteria
- •18 years or older
- •speaking and understanding Danish
- •providing written informed consent
排除标准
- •unable to understand study instructions
- •with an ischemic event within the past 6 months
- •who are pregnant or breastfeeding
- •with reduced ability to follow the planned programme due to i.e. substance abuse problems or other somatic illness
- •with considerable illness in the musculoskeletal system or with physical disability, which complicates exercise training
- •whose physician advise against participation
研究组 & 干预措施
Intervention group
Complex Cardiac Rehabilitation
干预措施: Complex Cardiac rehabilitation (Other)
Control group
Usual care
干预措施: Control group (Other)
结局指标
主要结局
Change in Mental component scale
时间窗: 1, 4, 6 and 12 months
Measured by the mental component scale (MCS) in the SF-36 questionnaire
次要结局
- Change in physical capacity(1, 4 and 6 months)
研究者
Selina Kikkenborg Berg
Principal investigator
Rigshospitalet, Denmark