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CHANGE -it is About Life

M

Mental Health Services in the Capital Region, Denmark

Status and phase

Completed
Phase 3

Conditions

Schizophrenia
Metabolic Syndrome

Treatments

Behavioral: Care coordinator
Other: Treatment as usual
Behavioral: CHANGE

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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.

Enrollment

428 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Prevention

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

428 participants in 3 patient groups

Treatment as usual
Active Comparator group
Description:
Treatment as usual
Treatment:
Other: Treatment as usual
Care coordinator
Active Comparator group
Treatment:
Behavioral: Care coordinator
CHANGE
Experimental group
Treatment:
Behavioral: CHANGE

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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