CopenHeart IE - Integrated Rehabilitation of Patients Treated for Infective Endocarditis
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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 |
- 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
- 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: | December 2014 |
| Estimated Primary Completion Date: | December 2013 (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 |
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| 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 | |
| Rigshospitalet / gentofte hospital | Recruiting |
| Copenhagen, Denmark, 2100 | |
| Contact: Trine b Rasmussen, MSN +45 35451205 copenheart@rh.dk | |
| 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: | December 3, 2012 |
| 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 Heart Diseases Cardiovascular Diseases |
Bacterial Infections Cardiovascular Infections Infection |
ClinicalTrials.gov processed this record on May 16, 2013