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CopenHeart IE - Integrated Rehabilitation of Patients Treated for Infective Endocarditis

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ClinicalTrials.gov Identifier: NCT01512615
Recruitment Status : Active, not recruiting
First Posted : January 19, 2012
Last Update Posted : June 4, 2018
Sponsor:
Collaborators:
University Hospital, Gentofte, Copenhagen
Copenhagen Trial Unit, Center for Clinical Intervention Research
Information provided by (Responsible Party):
Selina Kikkenborg Berg, Rigshospitalet, Denmark

Brief 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.


Condition or disease Intervention/treatment Phase
Infective Endocarditis Other: Complex Cardiac rehabilitation Other: Control group Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 117 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: RCT
Masking: Single (Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : December 2011
Actual Primary Completion Date : October 2016
Estimated Study Completion Date : October 2018


Arm Intervention/treatment
Experimental: Intervention group
Complex Cardiac Rehabilitation
Other: Complex Cardiac rehabilitation
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)

Experimental: Control group
Usual care
Other: Control group
Usual care, clinical control as provided by treating heart centre




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Change in physical capacity [ Time Frame: 1, 4 and 6 months ]
    Measured by Peak VO2 via ergospirometry testing



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Ages Eligible for Study:   18 Years to 95 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
Denmark
Rigshospitalet / gentofte hospital
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
University Hospital, Gentofte, Copenhagen
Copenhagen Trial Unit, Center for Clinical Intervention Research
Investigators
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Selina Kikkenborg Berg, Principal investigator, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01512615     History of Changes
Other Study ID Numbers: RHCopenHeartIE
First Posted: January 19, 2012    Key Record Dates
Last Update Posted: June 4, 2018
Last Verified: May 2018

Keywords provided by Selina Kikkenborg Berg, Rigshospitalet, Denmark:
Rehabilitation
Exercise training
Psycho-educational care

Additional relevant MeSH terms:
Endocarditis
Endocarditis, Bacterial
Heart Diseases
Cardiovascular Diseases
Bacterial Infections
Cardiovascular Infections
Infection