Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
428 participants
INTERVENTIONAL
2012-12-31
2016-06-30
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Treatment as usual
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
Care coordinator
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
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.
Interventions
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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
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.
Eligibility Criteria
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Inclusion Criteria
* Diagnose ICD-10:F2 spectrum
* Waist circumference \> 88 cm for women or \>102 cm for men
Exclusion Criteria
18 Years
ALL
No
Sponsors
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University of Copenhagen
OTHER
Mental Health Services in the Capital Region, Denmark
OTHER
Responsible Party
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Principal Investigators
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Merete Nordentoft, Professor
Role: PRINCIPAL_INVESTIGATOR
Mental Health Services in the Capital Region, Denmark
Locations
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Mental Health Services in the Capital Region, Denmark
Copenhagen, , Denmark
Countries
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References
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Speyer H, Norgaard HC, Hjorthoj C, Madsen TA, Drivsholm S, Pisinger C, Gluud C, Mors O, Krogh J, Nordentoft M. Protocol for CHANGE: a randomized clinical trial assessing lifestyle coaching plus care coordination versus care coordination alone versus treatment as usual to reduce risks of cardiovascular disease in adults with schizophrenia and abdominal obesity. BMC Psychiatry. 2015 May 23;15:119. doi: 10.1186/s12888-015-0465-2.
Other Identifiers
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Change
Identifier Type: -
Identifier Source: org_study_id