- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00514423
How Can Rehospitalisations of Patients With Schizophrenia be Avoided? A Comparison Between Different Compliance Programs
August 28, 2014 updated by: Technical University of Munich
Participation in one of the three interventions psychoeducation by professionals, psychoeducation by peer-moderators, or video-education can reduce the rehospitalisation rate of patients with schizophrenia compared to a control group.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Anticipated)
896
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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München, Germany, 81675
- Klinik und Poliklinik für Psychiatrie und Psychotherapie am Klinikum rechts der Isar der Technischen Universität München
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 67 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Schizophrenia or schizoaffective disorder (ICD-10)
- Age 18 to 67 years
- Hospitalised or treated in day care clinic
Exclusion Criteria:
- More than 12 months of hospitalisation within the last two years
- Substance-dependency (principal diagnosis)
- Mental retardation ICD-10 Chapter F70-79
- Fluency of German language not given
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 2
Psychoeducation by peer-moderators
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Experimental: 1
Psychoeducation by professionals
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|
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Experimental: 3
Video-education
|
|
|
Placebo Comparator: 4
Control group
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
|---|
|
Rehospitalisation rate
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Secondary Outcome Measures
Outcome Measure |
|---|
|
Quality of life
|
|
Compliance
|
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Rehospitalisation days
|
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Resulting costs per patient
|
|
Knowledge of illness
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Attitude towards illness
|
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Satisfaction with treatment
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Duration of consultation time
|
|
Dealing with mental illness
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Werner Kissling, MD, Technical University of Munich
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2006
Primary Completion (Actual)
December 1, 2011
Study Completion (Actual)
December 1, 2011
Study Registration Dates
First Submitted
August 9, 2007
First Submitted That Met QC Criteria
August 9, 2007
First Posted (Estimate)
August 10, 2007
Study Record Updates
Last Update Posted (Estimate)
August 29, 2014
Last Update Submitted That Met QC Criteria
August 28, 2014
Last Verified
August 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 01GL0509
- ISRCTN19638644
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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