CHANGE -it is About Life

CHANGE.A Randomized Clinical Trial of Health Promoting Programme Versus Standard Treatment for Patients With Schizophrenia

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia; Metabolic Syndrome
• Intervention / Treatment: Other: Treatment as usual; Behavioral: Care coordinator; Behavioral: CHANGE

• Study Type: Interventional
• Enrollment (Actual): 428
• Phase: Phase 3

Contacts and Locations

Study Locations

• Denmark
  • Copenhagen, Denmark, 2400
    • Mental Health Services in the Capital Region, Denmark

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Treatment as usual	Other: Treatment as usual; Treatment as usual. Patients will be affiliated with local out-patient clinics in secondary mental health services and they will have access to their own general practitioner. No formalized extra effort will be made to ensure treatment of physical disorders.Patients will be affiliated with local out-patient clinics in secondary
Active Comparator: Care coordinator	Behavioral: Care coordinator; Treatment as usual plus a care coordinator (with a caseload of 25 patients) who will facilitate contact to primary care in order to ensure treatment of physical health problems,
Experimental: CHANGE	Behavioral: CHANGE; Treatment as usual plus affiliation to a staffmember (caseload 10) from a CHANGE team who will provide individualized, adjusted implementation of widely recognized interventions, such as smoking cessation programmes, motivational interviewing, psychoeducation plus patient involvement in monitoring health statusA multidisciplinary CHANGE team will be established. Team members will be health professionals with experience in smoking cessation programmes or exercise programmes for mentally ill, and experts with competence in dietary issues. CHANGE treatment involve lifestyle coaching, education about diet and physical activity,16 networking and smoking cessation programs. The team members will act as lifestyle coaches for ten patients at a time, map lifestyle and explore and elicit patients' motivation for change.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Copenhagen Risk Score	The primary outcome is change in 10 years risk of cardiovascular disease from baseline at 12 months.	12 months

Secondary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Time Frame
Triglycerides	12 months
Quality of life	12 months
Positive and negative symptoms	12 months
Cognition	12 months
Dietary pattern	12 months
Self rated health	12 months
High sensitive CRP	12 months
Global assessment functioning (GAF)	12 months

Collaborators and Investigators

• Sponsor: Mental Health Services in the Capital Region, Denmark
• Collaborators: University of Copenhagen
• Investigators: Principal Investigator: Merete Nordentoft, Professor, Mental Health Centre Copenhagen

Publications and helpful links

General Publications

• Speyer H, Norgaard HC, Hjorthoj C, Madsen TA, Drivsholm S, Pisinger C, Gluud C, Mors O, Krogh J, Nordentoft M. 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. BMC Psychiatry. 2015 May 23;15:119. doi: 10.1186/s12888-015-0465-2.

Study record dates

Study Major Dates

• Study Start: December 1, 2012
• Primary Completion (Actual): June 1, 2016
• Study Completion (Actual): June 1, 2016

Study Registration Dates

• First Submitted: March 27, 2012
• First Submitted That Met QC Criteria: April 23, 2012
• First Posted (Estimate): April 26, 2012

Study Record Updates

• Last Update Posted (Estimate): October 27, 2016
• Last Update Submitted That Met QC Criteria: October 26, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Exercise; Smoking; Lifestyle; Dietary
• Additional Relevant MeSH Terms: Mental Disorders; Glucose Metabolism Disorders; Metabolic Diseases; Schizophrenia Spectrum and Other Psychotic Disorders; Insulin Resistance; Hyperinsulinism; Schizophrenia; Metabolic Syndrome
• Other Study ID Numbers: CHANGE