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Clinical Trials/NCT01585493
NCT01585493
Completed
Phase 3

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

Mental Health Services in the Capital Region, Denmark1 site in 1 country428 target enrollmentDecember 2012

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Schizophrenia
Sponsor
Mental Health Services in the Capital Region, Denmark
Enrollment
428
Locations
1
Primary Endpoint
Copenhagen Risk Score
Status
Completed
Last Updated
9 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
December 2012
End Date
June 2016
Last Updated
9 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Mental Health Services in the Capital Region, Denmark
Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Copenhagen Risk Score

Time Frame: 12 months

The primary outcome is change in 10 years risk of cardiovascular disease from baseline at 12 months.

Secondary Outcomes

  • Sedentary lifestyle(12)
  • Cholesterol(12 months)
  • Aerobic fitness(12 months)
  • Body mass index(12 months)
  • Blood pressure(12 months)
  • Waist circumference(12 months)
  • HbA1c(12 months)
  • Physical activity(12 months)
  • Smoking(12 months)
  • Forced expiratory volume(12 months)
  • Resting heart rate(12 months)

Study Sites (1)

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