Condition category
Mental and Behavioural Disorders
Date applied
02/11/2006
Date assigned
14/02/2007
Last edited
24/08/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Werner Kissling

ORCID ID

Contact details

Technical University Munich
Klinikum rechts der Isar
Department of Psychiatry and Psychotherapy
Moehlstrasse 26
Muenchen
81675
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00514423

Protocol/serial number

01GL0509

Study information

Scientific title

Acronym

Study hypothesis

Participation in one of the three interventions (psychoeducation by professionals, psychoeducation by peer-moderators or video-education) can reduce the rehospitalisation rate of schizophrenic patients compared to a control group.

Ethics approval

Approval received from the local ethics committee on the 10th February 2006 (ref: 1468/06).

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Schizophrenia or schizoaffective disorder

Intervention

1. Psychoeducation by professionals
2. Psychoeducation by peer-moderators
3. Video-education

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Rehospitalisation rate

Secondary outcome measures

1. Rehospitalisation days
2. Resulting costs per patient
3. Cost-benefit-analysis of the different interventions
4. Compliance
5. Compliance self-assesment (Medication Adherence Rating Scale [MARS]/Drug Attitude Inventory [DAI])
6. Knowledge of illness
7. Attitude towards illness
8. Quality of life (World Health Organisation Quality Of Life [WHOQOL]-BREF)
9. Satisfaction questionnaire (ZUF-8)
10. Duration of consultation time
11. Dealing with mental illness (Mantonakis, Family Member Questionnaire [FMQ], Beck Depression Inventory [BDI])

Overall trial start date

01/09/2006

Overall trial end date

31/12/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Schizophrenia or schizoaffective disorder (International Classification of Diseases [ICD-10])
2. Age 18 to 67 years
3. Hospitalised or treated in a day care clinic

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

896 patients, family members as available

Participant exclusion criteria

1. More than 12 months of hospitalisation within the last two years
2. Substance-dependency (principal diagnosis)
3. Mental retardation ICD-10 Chapter F70-79
4. Fluency of German language not given

Recruitment start date

01/09/2006

Recruitment end date

31/12/2007

Locations

Countries of recruitment

Germany

Trial participating centre

Technical University Munich
Muenchen
81675
Germany

Sponsor information

Organisation

Technical University Munich (Germany)

Sponsor details

Klinikum rechts der Isar
Department of Psychiatry and Psychotherapy
Moehlstrasse 26
Muenchen
81675
Germany

Sponsor type

University/education

Website

http://www.tum.de/

Funders

Funder type

Government

Funder name

Federal Ministry of Education and Research (Bundesministerium für Bildung und Forschung [BMBF]) (Germany) (grant ref: 01GL0509)

Alternative name(s)

Federal Ministry of Education and Research, BMBF

Funding Body Type

government organisation

Funding Body Subtype

federal

Location

Germany

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes