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CopenHeart IE - Integrated Rehabilitation of Patients Treated for Infective Endocarditis

This study is currently recruiting participants.
Verified December 2012 by Rigshospitalet, Denmark
Sponsor:
Collaborators:
University Hospital, Gentofte, Copenhagen
Copenhagen Trial Unit, Center for Clinical Intervention Research
Information provided by (Responsible Party):
Selina Kikkenborg Berg, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT01512615
First received: January 11, 2012
Last updated: December 3, 2012
Last verified: December 2012
History of Changes

January 11, 2012
December 3, 2012
December 2011
December 2013   (final data collection date for primary outcome measure)
Change in Mental component scale [ Time Frame: 1, 4, 6 and 12 months ] [ Designated as safety issue: No ]
Measured by the mental component scale (MCS) in the SF-36 questionnaire
Same as current
Complete list of historical versions of study NCT01512615 on ClinicalTrials.gov Archive Site
Change in physical capacity [ Time Frame: 1, 4 and 6 months ] [ Designated as safety issue: Yes ]
Measured by Peak VO2 via ergospirometry testing
Same as current
Not Provided
Not Provided
 
CopenHeart IE - Integrated Rehabilitation of Patients Treated for Infective Endocarditis
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.
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Infective Endocarditis
  • 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)
  • Other: Usual follow-up
    Standard follow-up at the participating heart center
  • Experimental: Intervention group
    Intervention: Other: Integrated rehabilitation
  • Experimental: Control group
    Intervention: Other: Usual follow-up
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
150
December 2014
December 2013   (final data collection date for primary outcome measure)

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
Both
18 Years to 95 Years
No
Contact: Trine B Rasmussen, PhD fellow +45 35451205 trine.b.rasmussen@regionh.rh.dk
Contact: Kirstine L Sibilitz, PhD fellow +45 35451205 kirstine.laerum.sibilitz@rh.dk
Denmark
 
NCT01512615
RHCopenHeartIE
Yes
Selina Kikkenborg Berg, Rigshospitalet, Denmark
Rigshospitalet, Denmark
  • University Hospital, Gentofte, Copenhagen
  • Copenhagen Trial Unit, Center for Clinical Intervention Research
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
Rigshospitalet, Denmark
December 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP