CopenHeart IE - Integrated Rehabilitation of Patients Treated for Infective Endocarditis

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Infective Endocarditis

Intervention / Treatment
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* Other: Complex Cardiac rehabilitation
* Other: Control group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients: 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 Exclusion Criteria: Patients: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 95 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: RCT
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Complex Cardiac Rehabilitation | Other: Complex Cardiac rehabilitation<br>* 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)<br>|
| Experimental: Control group<br>Usual care | Other: Control group<br>* Usual care, clinical control as provided by treating heart centre<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Mental component scale | Measured by the mental component scale (MCS) in the SF-36 questionnaire | 1, 4, 6 and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in physical capacity | Measured by Peak VO2 via ergospirometry testing | 1, 4 and 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Rehabilitation, Exercise training, Psycho-educational care