CopenHeart IE - Integrated Rehabilitation of Patients Treated for Infective Endocarditis

Infective Endocarditis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01512615
• Other study ID #: RHCopenHeartIE
• Status: Completed
• Phase: N/A
• Start date: December 2011
• Est. completion date: October 15, 2018

Study information

• Verified date: September 2019
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 117
• Est. completion date: October 15, 2018
• Est. primary completion date: October 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 95 Years

Eligibility

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

Related Conditions & MeSH terms

• Endocarditis
• Endocarditis, Bacterial
• Infective Endocarditis

Intervention

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)
• Control group
Usual care, clinical control as provided by treating heart centre

Locations

Country	Name	City	State
Denmark	Rigshospitalet / gentofte hospital	Copenhagen

Sponsors (3)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Copenhagen Trial Unit, Center for Clinical Intervention Research, University Hospital, Gentofte, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Mental component scale	Measured by the mental component scale (MCS) in the SF-36 questionnaire	1, 4, 6 and 12 months
Secondary	Change in physical capacity	Measured by Peak VO2 via ergospirometry testing	1, 4 and 6 months