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Published in: BMC Psychiatry 1/2015

Open Access 01-12-2015 | Study protocol

Protocol for CHANGE: a randomized clinical trial assessing lifestyle coaching plus care coordination versus care coordination alone versus treatment as usual to reduce risks of cardiovascular disease in adults with schizophrenia and abdominal obesity

Authors: Helene Speyer, Hans Christian Brix Nørgaard, Carsten Hjorthøj, Thomas Axel Madsen, Søren Drivsholm, Charlotta Pisinger, Christian Gluud, Ole Mors, Jesper Krogh, Merete Nordentoft

Published in: BMC Psychiatry | Issue 1/2015

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Abstract

Background

Life expectancy in patients with schizophrenia is reduced by 20 years for males and 15 years for females compared to the general population. About 60% of the excess mortality is due to physical illnesses, with cardiovascular disease being the single largest cause of death.

Methods/design

The CHANGE trial is an investigator-initiated, independently funded, randomized, parallel-group, superiority, multi-centre trial with blinded outcome assessment. 450 patients aged 18 years or above, diagnosed with schizophrenia spectrum disorders and increased waist circumference, will be recruited and randomized 1:1:1 to 12-months interventions. We will compare the effects of 1) affiliation to the CHANGE team, offering a tailored, manual-based intervention targeting physical inactivity, unhealthy dietary habits, and smoking, and facilitating contact to their general practitioner to secure medical treatment of somatic comorbidity; versus 2) affiliation to a care coordinator who will secure guideline-concordant monitoring and treatment of somatic comorbidity by facilitating contact to their general practitioner; versus 3) treatment as usual to evaluate the potential add-on effects of lifestyle coaching plus care coordination or care coordination alone to treatment as usual. The primary outcome is the 10-year risks of cardiovascular disease assessed at 12 months after randomization.

Discussion

The premature mortality observed in this vulnerable population has not formerly been addressed specifically by using composite surrogate outcomes for mortality. The CHANGE trial expands the evidence for interventions aiming to reduce the burden of metabolic disturbances with a view to increase life expectancy. Here, we present the trial design, describe the methodological concepts in detail, and discuss the rationale and challenges of the intermediate outcomes.

Trial registration

Clinical Trials.gov NCT01585493. Date of registration 27th of March 2012.
Appendix
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Metadata
Title
Protocol for CHANGE: a randomized clinical trial assessing lifestyle coaching plus care coordination versus care coordination alone versus treatment as usual to reduce risks of cardiovascular disease in adults with schizophrenia and abdominal obesity
Authors
Helene Speyer
Hans Christian Brix Nørgaard
Carsten Hjorthøj
Thomas Axel Madsen
Søren Drivsholm
Charlotta Pisinger
Christian Gluud
Ole Mors
Jesper Krogh
Merete Nordentoft
Publication date
01-12-2015
Publisher
BioMed Central
Published in
BMC Psychiatry / Issue 1/2015
Electronic ISSN: 1471-244X
DOI
https://doi.org/10.1186/s12888-015-0465-2

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