CopenHeart IE - Integrated Rehabilitation of Patients Treated for Infective Endocarditis

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 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: September 1, 2014
Last verified: September 2014
  Purpose

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 Intervention Phase
Infective Endocarditis
Other: Integrated rehabilitation
Other: Usual follow-up
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
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

Resource links provided by NLM:


Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • Change in physical capacity [ Time Frame: 1, 4 and 6 months ] [ Designated as safety issue: Yes ]
    Measured by Peak VO2 via ergospirometry testing


Estimated Enrollment: 150
Study Start Date: December 2011
Estimated Study Completion Date: September 2016
Estimated Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 95 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01512615

Contacts
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

Locations
Denmark
Rigshospitalet / gentofte hospital Recruiting
Copenhagen, Denmark, 2100
Contact: Trine b Rasmussen, MSN    +45 35451205    copenheart@rh.dk   
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
  More Information

No publications provided

Responsible Party: Selina Kikkenborg Berg, Principal investigator, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT01512615     History of Changes
Other Study ID Numbers: RHCopenHeartIE
Study First Received: January 11, 2012
Last Updated: September 1, 2014
Health Authority: Denmark: Ethics Committee
Denmark: Danish Dataprotection Agency

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

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

ClinicalTrials.gov processed this record on October 22, 2014