TY - JOUR

T1 - Protocol for CHANGE

T2 - 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

AU - Speyer, Helene

AU - Nørgaard, Hans Christian Brix

AU - Hjorthøj, Carsten

AU - Madsen, Thomas Axel

AU - Drivsholm, Søren

AU - Pisinger, Charlotta

AU - Gluud, Christian

AU - Mors, Ole

AU - Krogh, Jesper

AU - Nordentoft, Merete

PY - 2015/5/23

Y1 - 2015/5/23

N2 - 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.

AB - 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.

KW - Cardiovascular Diseases

KW - Clinical Protocols

KW - Counseling

KW - Female

KW - Humans

KW - Life Style

KW - Male

KW - Middle Aged

KW - Obesity, Abdominal

KW - Schizophrenia

U2 - 10.1186/s12888-015-0465-2

DO - 10.1186/s12888-015-0465-2

M3 - Journal article

C2 - 26001844

VL - 15

SP - 1

EP - 11

JO - B M C Psychiatry

JF - B M C Psychiatry

SN - 1471-244X

M1 - 119

ER -