Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2015 May 23:15:119.
doi: 10.1186/s12888-015-0465-2.

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

Helene Speyer  1   2 , Hans Christian Brix Nørgaard  3 , Carsten Hjorthøj  4   5 , Thomas Axel Madsen  6 , Søren Drivsholm  7 , Charlotta Pisinger  8 , Christian Gluud  9 , Ole Mors  10 , Jesper Krogh  11 , Merete Nordentoft  12   13
Affiliations
Randomized Controlled Trial

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

Helene Speyer et al. BMC Psychiatry. .

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 27(th) of March 2012.

PubMed Disclaimer

Figures

Figure 1
Figure 1
10 years risk of CVD estimated with Copenhagen Risk Score, Vo2max = max. oxygen uptake, BP = blood pressure, RHR = resting heart rate, HbA1c = glycosylated haemoglobin, MVPA = moderate/vigorous activity, inactivity = sedentary activity, FEV1 = forced expiratory volume.
Figure 2
Figure 2
The decision tree incorporated in the care coordinator function.
See this image and copyright information in PMC

References

    1. Nordentoft M, Wahlbeck K, Hällgren J, Westman J, Osby U, Alinaghizadeh H, et al. Excess mortality, causes of death and life expectancy in 270,770 patients with recent onset of mental disorders in Denmark, Finland and Sweden. PLoS One. 2013;8(1) doi: 10.1371/journal.pone.0055176. - DOI - PMC - PubMed
    1. Lawrence D, Hancock KJ, Kisely S. The gap in life expectancy from preventable physical illness in psychiatric patients in Western Australia: retrospective analysis of population based registers. Bmj. 2013;346(may21 1):f2539. doi: 10.1136/bmj.f2539. - DOI - PMC - PubMed
    1. Saha S, Chant D, Mcgrath J. Syst Rev Mortality Schizophrenia. 2013;64(10):1123–31. - PubMed
    1. Chan A-W, Tetzlaff JM, Gotzsche PC, Altman DG, Mann H, Berlin JA, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ (Clin Res Ed) 2013;346 - PMC - PubMed
    1. Laursen TM, Nordentoft M. Heart disease treatment and mortality in schizophrenia and bipolar disorder - changes in the Danish population between 1994 and 2006. J Psychiatr Res. 2011;45(1):29–35. doi: 10.1016/j.jpsychires.2010.04.027. - DOI - PubMed

Publication types

Associated data