CHANGE -it is About Life

Schizophrenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01585493
• Other study ID #: Change
• Status: Completed
• Phase: Phase 3
• First received: March 27, 2012
• Last updated: October 26, 2016
• Start date: December 2012
• Est. completion date: June 2016

Study information

• Verified date: October 2016
• Source: Mental Health Services in the Capital Region, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: National Board of Health
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 428
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Schizophrenia

Intervention

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

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,
• 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.

Locations

Country	Name	City	State
Denmark	Mental Health Services in the Capital Region, Denmark	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Mental Health Services in the Capital Region, Denmark	University of Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Positive and negative symptoms		12 months	No
Other	Cognition		12 months	No
Other	Quality of life		12 months	No
Other	Dietary pattern		12 months	No
Other	Self rated health		12 months	No
Other	High sensitive CRP		12 months	No
Other	Triglycerides		12 months	No
Other	Global assessment functioning (GAF)		12 months	No
Primary	Copenhagen Risk Score	The primary outcome is change in 10 years risk of cardiovascular disease from baseline at 12 months.	12 months	No
Secondary	Smoking	Number of daily smokers in each group at 12 months	12 months	No
Secondary	Sedentary lifestyle	Self reported hours of sedentary behavior	12	No
Secondary	Body mass index	Change in body mass index at 12 months	12 months	No
Secondary	Blood pressure	Change in systolic and diastolic blood pressure at 12 months	12 months	No
Secondary	Cholesterol	Change in total Cholesterol, LDL, HDL, and triglycerides and 12 months	12 months	No
Secondary	Aerobic fitness	Indirectly estimated maximal oxygen uptake	12 months	No
Secondary	Waist circumference	Measured between crista iliaca and the lowest rib	12 months	No
Secondary	Forced expiratory volume		12 months	No
Secondary	Resting heart rate		12 months	No
Secondary	HbA1c		12 months	No
Secondary	Physical activity	Change in minutes of MVPA a week	12 months	No