CopenHeart IE - Integrated Rehabilitation of Patients Treated for Infective Endocarditis
Condition: Infective Endocarditis
MeSH terms: Endocarditis, Bacterial; Endocarditis
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Complex Cardiac rehabilitation; Control group
Intervention type(s): Other; Other
Intervention description(s): Complex Cardiac Rehabilitation consisting of exercise training (minimum 3 times a week for a total of twelve weeks) and psychoeducational care (5 sessions over 6 months); Usual care, clinical control as provided by treating heart centre
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: RCT
Masking: Single (Outcomes Assessor)
Primary purpose: Prevention
Keywords: Rehabilitation; Exercise training; Psycho-educational care