CopenHeart IE - Integrated Rehabilitation of Patients Treated for Infective Endocarditis

September 10, 2019 updated by: Selina Kikkenborg Berg, Rigshospitalet, Denmark

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

117

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Copenhagen, Denmark, 2100
        • Rigshospitalet / gentofte hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 95 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1, 4, 6 and 12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Collaborators

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: 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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

December 1, 2011

Primary Completion (ACTUAL)

October 1, 2016

Study Completion (ACTUAL)

October 15, 2018

Study Registration Dates

First Submitted

January 11, 2012

First Submitted That Met QC Criteria

January 14, 2012

First Posted (ESTIMATE)

January 19, 2012

Study Record Updates

Last Update Posted (ACTUAL)

September 11, 2019

Last Update Submitted That Met QC Criteria

September 10, 2019

Last Verified

September 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RHCopenHeartIE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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