Ignite Creation Date:
2025-12-25 @ 1:05 AM
Ignite Modification Date:
2025-12-31 @ 11:38 AM
Study NCT ID:
NCT01585493
Status:
COMPLETED
Last Update Posted:
2016-10-27
First Post:
2012-03-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CHANGE -it is About Life
Sponsor:
Mental Health Services in the Capital Region, Denmark
Organization:
Study Overview
Official Title:
CHANGE.A Randomized Clinical Trial of Health Promoting Programme Versus Standard Treatment for Patients With Schizophrenia
Status:
COMPLETED
Status Verified Date:
2016-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: