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Completed

NCT Number: NCT01585493

CHANGE -it is About Life

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Mental Health Services in the Capital Region, Denmark

Copenhagen, 2400, Denmark

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Treatment as Usual

Other

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

Care coordinator

Behavioral

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

Behavioral

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

  1. 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

  1. Smoking

    Time frame: 12 months

    Number of daily smokers in each group at 12 months

  2. Sedentary lifestyle

    Time frame: 12

    Self reported hours of sedentary behavior

  3. Body mass index

    Time frame: 12 months

    Change in body mass index at 12 months

  4. Blood pressure

    Time frame: 12 months

    Change in systolic and diastolic blood pressure at 12 months

  5. Cholesterol

    Time frame: 12 months

    Change in total Cholesterol, LDL, HDL, and triglycerides and 12 months

  6. Aerobic fitness

    Time frame: 12 months

    Indirectly estimated maximal oxygen uptake

  7. Waist circumference

    Time frame: 12 months

    Measured between crista iliaca and the lowest rib

  8. Forced expiratory volume

    Time frame: 12 months

  9. Resting heart rate

    Time frame: 12 months

  10. HbA1c

    Time frame: 12 months

  11. Physical activity

    Time frame: 12 months

    Change in minutes of MVPA a week

Other outcomes

  1. Positive and negative symptoms

    Time frame: 12 months

  2. Cognition

    Time frame: 12 months

  3. Quality of life

    Time frame: 12 months

  4. Dietary pattern

    Time frame: 12 months

  5. Self rated health

    Time frame: 12 months

  6. High sensitive CRP

    Time frame: 12 months

  7. Triglycerides

    Time frame: 12 months

  8. Global assessment functioning (GAF)

    Time frame: 12 months

Sponsors and collaborators

Lead sponsor

Mental Health Centre Copenhagen, Bispebjerg and Frederiksberg Hospital

Other

Collaborators

  • University of Copenhagen

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2016
Study completion
2016
First posted
Apr 26, 2012
Registry last updated
Oct 27, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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