CHANGE -it is About Life

Phase 3

Completed

• Conditions: Schizophrenia; Metabolic Syndrome
• Interventions: Other: Treatment as usual; Behavioral: CHANGE; Behavioral: Care coordinator

• Registration Number: NCT01585493
• Lead Sponsor: Mental Health Services in the Capital Region, Denmark

Brief Summary

Schizophrenia is a life shortening disease, not only because of suicide but also because of increased mortality from natural causes. Recently, a large register-based study, involving complete national data from Denmark, Sweden and Finland, showed that life expectancy for schizophrenia is 20 years shorter for men and 15 years shorter for women, compared to the general population, and that mortality from medical conditions and diseases are responsible for a large proportion of the reduced life expectancy. Patients with schizophrenia had a twofold to fivefold increased risk of death by coronary heart disease, respiratory diseases, lung cancer and metabolic conditions. Unhealthy life style and undetected and untreated physical disorders play an important role in this excess mortality.Results from the Danish National Indicator Project for Schizophrenia showed that a much higher proportion of patients with schizophrenia compared to the general population have measures of waist circumference, body mass index, blood pressure, blood lipids and blood glucoses above the recommended upper values.

In the randomized clinical trial CHANGE, the investigators will evaluate the effect of two different interventions both aiming to reduce risk for death from medical diseases. We will compare 1) treatment as usual with 2) affiliation to a care coordinator who has the duty to connect the patient to general practice and primary care and 3) affiliation to a staff member from the CHANGE team who should facilitate life style changes and contact with general practice. The objective is to identify interventions that can reduce the risk of early death in patients with schizophrenia.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-03-27
• Study First Submitted QC: 2012-04-23
• Study First Posted: 2012-04-26
• Study Start: 2012-12
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-26
• Last Update Posted: 2016-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 428

Inclusion Criteria

• Affiliated to outpatients services at Mental Health Centre, Copenhagen or Århus University Hospital
• Diagnose ICD-10:F2 spectrum
• Waist circumference > 88 cm for women or >102 cm for men

Exclusion Criteria

• Not willing to participate

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment as usual	Treatment as usual	Treatment as usual
CHANGE	CHANGE	-
Care coordinator	Care coordinator	-

Primary Outcome Measures

Name	Time	Method
Copenhagen Risk Score	12 months	The primary outcome is change in 10 years risk of cardiovascular disease from baseline at 12 months.

Secondary Outcome Measures

Name	Time	Method
Sedentary lifestyle	12	Self reported hours of sedentary behavior
Cholesterol	12 months	Change in total Cholesterol, LDL, HDL, and triglycerides and 12 months
Aerobic fitness	12 months	Indirectly estimated maximal oxygen uptake
Body mass index	12 months	Change in body mass index at 12 months
Blood pressure	12 months	Change in systolic and diastolic blood pressure at 12 months
Waist circumference	12 months	Measured between crista iliaca and the lowest rib
HbA1c	12 months
Physical activity	12 months	Change in minutes of MVPA a week
Smoking	12 months	Number of daily smokers in each group at 12 months
Forced expiratory volume	12 months
Resting heart rate	12 months

Trial Locations

Locations (1)

Mental Health Services in the Capital Region, Denmark; 🇩🇰 Copenhagen, Denmark