Clinical trial NCT01512615: CopenHeart IE - Integrated Rehabilitation of Patients Treated for Infective Endocarditis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Infective Endocarditis
Keywords: Rehabilitation
Exercise training
Psycho-educational care
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: University Hospital, Gentofte, Copenhagen
name: Copenhagen Trial Unit, Center for Clinical Intervention Research
First posted: 2012-01-19
Enrollment: 117
Sex: ALL
Minimum age (years): 18
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RCT
Primary purpose: PREVENTION

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.

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 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

Primary outcomes:
measure: Change in Mental component scale
timeFrame: 1, 4, 6 and 12 months
Secondary outcomes:
measure: Change in physical capacity
timeFrame: 1, 4 and 6 months
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Rigshospitalet / gentofte hospital
Study officials:
affiliation: Copenhagen University Hospital Rigshospitalet, University Hospital Gentofte
name: Trine B Rasmussen, PhD fellow
role: PRINCIPAL_INVESTIGATOR
affiliation: Copenhagen University Hospital Rigshospitalet, University Hospital Gentofte
name: Selina K Berg, MScN, Ph.d.
role: PRINCIPAL_INVESTIGATOR
affiliation: Copenhagen University Hospital Rigshospitalet, National Institute of Public Health, University of Southern Denmark
name: Ann-Dorthe Zwisler, MD, Ph.d.
role: PRINCIPAL_INVESTIGATOR
affiliation: Rigshospitalet, Denmark
name: Henning Bundgaard, MD, Ph.d.
role: PRINCIPAL_INVESTIGATOR
affiliation: Centre for Health Services and Nursing Research, KU Leuven-University of
name: Philip Moons, Prof, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rasmussen TB, Zwisler AD, Risom SS, Sibilitz KL, Christensen J, Bundgaard H, Moons P, Thygesen LC, Lindschou J, Norekval TM, Berg SK. Comprehensive cardiac rehabilitation for patients following infective endocarditis: results of the randomized CopenHeartIE trial. Eur J Cardiovasc Nurs. 2022 Apr 9;21(3):261-270. doi: 10.1093/eurjcn/zvab047.
citation: Rasmussen TB, Zwisler AD, Moons P, Berg SK. Insufficient living: experiences of recovery after infective endocarditis. J Cardiovasc Nurs. 2015 May-Jun;30(3):E11-9. doi: 10.1097/JCN.0000000000000144.
citation: Rasmussen TB, Zwisler AD, Sibilitz KL, Risom SS, Bundgaard H, Gluud C, Moons P, Winkel P, Thygesen LC, Hansen JL, Norekval TM, Berg SK; CopenHeartIE Group. A randomised clinical trial of comprehensive cardiac rehabilitation versus usual care for patients treated for infective endocarditis--the CopenHeartIE trial protocol. BMJ Open. 2012 Nov 21;2(6):e001929. doi: 10.1136/bmjopen-2012-001929. Print 2012.