CHANGE -it is About Life
Primary Purpose
Schizophrenia, Metabolic Syndrome
Status
Completed
Phase
Phase 3
Locations
Denmark
Study Type
Interventional
Intervention
Treatment as usual
Care coordinator
CHANGE
Sponsored by
About this trial
This is an interventional prevention trial for Schizophrenia focused on measuring Lifestyle, Smoking, Dietary, Exercise
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
Sites / Locations
- Mental Health Services in the Capital Region, Denmark
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Experimental
Arm Label
Treatment as usual
Care coordinator
CHANGE
Arm Description
Treatment as usual
Outcomes
Primary Outcome Measures
Copenhagen Risk Score
The primary outcome is change in 10 years risk of cardiovascular disease from baseline at 12 months.
Secondary Outcome Measures
Smoking
Number of daily smokers in each group at 12 months
Sedentary lifestyle
Self reported hours of sedentary behavior
Body mass index
Change in body mass index at 12 months
Blood pressure
Change in systolic and diastolic blood pressure at 12 months
Cholesterol
Change in total Cholesterol, LDL, HDL, and triglycerides and 12 months
Aerobic fitness
Indirectly estimated maximal oxygen uptake
Waist circumference
Measured between crista iliaca and the lowest rib
Forced expiratory volume
Resting heart rate
HbA1c
Physical activity
Change in minutes of MVPA a week
Full Information
NCT ID
NCT01585493
First Posted
March 27, 2012
Last Updated
October 26, 2016
Sponsor
Mental Health Services in the Capital Region, Denmark
Collaborators
University of Copenhagen
1. Study Identification
Unique Protocol Identification Number
NCT01585493
Brief Title
CHANGE -it is About Life
Official Title
CHANGE.A Randomized Clinical Trial of Health Promoting Programme Versus Standard Treatment for Patients With Schizophrenia
Study Type
Interventional
2. Study Status
Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
December 2012 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mental Health Services in the Capital Region, Denmark
Collaborators
University of Copenhagen
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Metabolic Syndrome
Keywords
Lifestyle, Smoking, Dietary, Exercise
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
428 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment as usual
Arm Type
Active Comparator
Arm Description
Treatment as usual
Arm Title
Care coordinator
Arm Type
Active Comparator
Arm Title
CHANGE
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Treatment as usual
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Care coordinator
Intervention Description
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,
Intervention Type
Behavioral
Intervention Name(s)
CHANGE
Intervention Description
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 Outcome Measure Information:
Title
Copenhagen Risk Score
Description
The primary outcome is change in 10 years risk of cardiovascular disease from baseline at 12 months.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Smoking
Description
Number of daily smokers in each group at 12 months
Time Frame
12 months
Title
Sedentary lifestyle
Description
Self reported hours of sedentary behavior
Time Frame
12
Title
Body mass index
Description
Change in body mass index at 12 months
Time Frame
12 months
Title
Blood pressure
Description
Change in systolic and diastolic blood pressure at 12 months
Time Frame
12 months
Title
Cholesterol
Description
Change in total Cholesterol, LDL, HDL, and triglycerides and 12 months
Time Frame
12 months
Title
Aerobic fitness
Description
Indirectly estimated maximal oxygen uptake
Time Frame
12 months
Title
Waist circumference
Description
Measured between crista iliaca and the lowest rib
Time Frame
12 months
Title
Forced expiratory volume
Time Frame
12 months
Title
Resting heart rate
Time Frame
12 months
Title
HbA1c
Time Frame
12 months
Title
Physical activity
Description
Change in minutes of MVPA a week
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Positive and negative symptoms
Time Frame
12 months
Title
Cognition
Time Frame
12 months
Title
Quality of life
Time Frame
12 months
Title
Dietary pattern
Time Frame
12 months
Title
Self rated health
Time Frame
12 months
Title
High sensitive CRP
Time Frame
12 months
Title
Triglycerides
Time Frame
12 months
Title
Global assessment functioning (GAF)
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Merete Nordentoft, Professor
Organizational Affiliation
Mental Health Centre Copenhagen
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mental Health Services in the Capital Region, Denmark
City
Copenhagen
ZIP/Postal Code
2400
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
26001844
Citation
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.
Results Reference
derived
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