Overview

This trial is active, not recruiting.

Conditions schizophrenia, metabolic syndrome
Treatments treatment as usual, care coordinator, change
Phase phase 3
Sponsor Mental Health Services in the Capital Region, Denmark
Collaborator University of Copenhagen
Start date December 2012
End date May 2016
Trial size 430 participants
Trial identifier NCT01585493, Change

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking single blind (outcomes assessor)
Primary purpose prevention
Arm
(Active Comparator)
Treatment as usual
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
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
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.

Primary Outcomes

Measure
Copenhagen Risk Score
time frame: 12 months

Secondary Outcomes

Measure
Smoking
time frame: 12 months
Sedentary lifestyle
time frame: 12
Body mass index
time frame: 12 months
Blood pressure
time frame: 12 months
Cholesterol
time frame: 12 months
Aerobic fitness
time frame: 12 months
Waist circumference
time frame: 12 months
Forced expiratory volume
time frame: 12 months
Resting heart rate
time frame: 12 months
HbA1c
time frame: 12 months
Physical activity
time frame: 12 months

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title CHANGE.A Randomized Clinical Trial of Health Promoting Programme Versus Standard Treatment for Patients With Schizophrenia
Principal investigator Merete Nordentoft, Professor
Trial information was received from ClinicalTrials.gov and was last updated in March 2015.
Information provided to ClinicalTrials.gov by Mental Health Services in the Capital Region, Denmark.