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How Can Rehospitalisations of Patients With Schizophrenia be Avoided? A Comparison Between Different Compliance Programs

Primary Purpose

Schizophrenia, Schizoaffective Disorder

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Psychoeducation by professonals
Psychoeducation by peer-moderators
Video-education
Noneducational video group (control group)
Sponsored by
Technical University of Munich
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Schizophrenia

Eligibility Criteria

18 Years - 67 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Klinik und Poliklinik für Psychiatrie und Psychotherapie am Klinikum rechts der Isar der Technischen Universität München

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

2

1

3

4

Arm Description

Psychoeducation by peer-moderators

Psychoeducation by professionals

Video-education

Control group

Outcomes

Primary Outcome Measures

Rehospitalisation rate

Secondary Outcome Measures

Rehospitalisation days
Resulting costs per patient
Compliance
Knowledge of illness
Attitude towards illness
Quality of life
Satisfaction with treatment
Duration of consultation time
Dealing with mental illness

Full Information

First Posted
August 9, 2007
Last Updated
August 28, 2014
Sponsor
Technical University of Munich
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1. Study Identification

Unique Protocol Identification Number
NCT00514423
Brief Title
How Can Rehospitalisations of Patients With Schizophrenia be Avoided? A Comparison Between Different Compliance Programs
Official Title
How Can Rehospitalisations of Patients With Schizophrenia be Avoided? A Comparison Between Different Compliance Programs
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Technical University of Munich

4. Oversight

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia, Schizoaffective Disorder

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
896 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
2
Arm Type
Experimental
Arm Description
Psychoeducation by peer-moderators
Arm Title
1
Arm Type
Experimental
Arm Description
Psychoeducation by professionals
Arm Title
3
Arm Type
Experimental
Arm Description
Video-education
Arm Title
4
Arm Type
Placebo Comparator
Arm Description
Control group
Intervention Type
Other
Intervention Name(s)
Psychoeducation by professonals
Intervention Type
Other
Intervention Name(s)
Psychoeducation by peer-moderators
Intervention Type
Other
Intervention Name(s)
Video-education
Intervention Type
Other
Intervention Name(s)
Noneducational video group (control group)
Primary Outcome Measure Information:
Title
Rehospitalisation rate
Secondary Outcome Measure Information:
Title
Rehospitalisation days
Title
Resulting costs per patient
Title
Compliance
Title
Knowledge of illness
Title
Attitude towards illness
Title
Quality of life
Title
Satisfaction with treatment
Title
Duration of consultation time
Title
Dealing with mental illness

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
67 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Werner Kissling, MD
Organizational Affiliation
Technical University of Munich
Official's Role
Principal Investigator
Facility Information:
Facility Name
Klinik und Poliklinik für Psychiatrie und Psychotherapie am Klinikum rechts der Isar der Technischen Universität München
City
München
ZIP/Postal Code
81675
Country
Germany

12. IPD Sharing Statement

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How Can Rehospitalisations of Patients With Schizophrenia be Avoided? A Comparison Between Different Compliance Programs

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