CopenHeart IE - Integrated Rehabilitation of Patients Treated for Infective Endocarditis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01512615|
Recruitment Status : Recruiting
First Posted : January 19, 2012
Last Update Posted : November 29, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Infective Endocarditis||Other: Integrated rehabilitation Other: Usual follow-up||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||150 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||December 2011|
|Estimated Primary Completion Date :||May 2017|
|Estimated Study Completion Date :||November 2018|
|Experimental: Intervention group||
Other: Integrated rehabilitation
Integrated Rehabilitation consisting of exercise training (minimum 3 times a week for a total of twelve weeks) and psychoeducational care (5 sessions over 6 months)
|Experimental: Control group||
Other: Usual follow-up
Standard follow-up at the participating heart center
- Change in Mental component scale [ Time Frame: 1, 4, 6 and 12 months ]Measured by the mental component scale (MCS) in the SF-36 questionnaire
- Change in physical capacity [ Time Frame: 1, 4 and 6 months ]Measured by Peak VO2 via ergospirometry testing
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01512615
|Contact: Trine B Rasmussen, PhD fellow||+45 firstname.lastname@example.org|
|Contact: Kirstine L Sibilitz, PhD fellow||+45 email@example.com|
|Rigshospitalet / gentofte hospital||Recruiting|
|Copenhagen, Denmark, 2100|
|Contact: Trine b Rasmussen, MSN +45 35451205 firstname.lastname@example.org|
|Principal Investigator:||Trine B Rasmussen, PhD fellow||Copenhagen University Hospital Rigshospitalet, University Hospital Gentofte|
|Principal Investigator:||Selina K Berg, MScN, Ph.d.||Copenhagen University Hospital Rigshospitalet, University Hospital Gentofte|
|Principal Investigator:||Ann-Dorthe Zwisler, MD, Ph.d.||Copenhagen University Hospital Rigshospitalet, National Institute of Public Health, University of Southern Denmark|
|Principal Investigator:||Henning Bundgaard, MD, Ph.d.||Rigshospitalet, Denmark|
|Principal Investigator:||Philip Moons, Prof, PhD||Centre for Health Services and Nursing Research, KU Leuven—University of|