Infective Endocarditis Clinical Trial
Official title:
CopenHeart IE - A Randomized Clinical Trial Investigating the Effect and Meaning of Integrated Rehabilitation Versus Usual Follow-up of Patients Treated for Infective Endocarditis
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.
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.
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