How can rehospitalisations of patients with schizophrenia be avoided? A comparison between different compliance programs

ISRCTN	ISRCTN19638644
DOI	https://doi.org/10.1186/ISRCTN19638644
ClinicalTrials.gov (NCT)	NCT00514423
Protocol serial number	01GL0509
Sponsor	Technical University Munich (Germany)
Funder	Federal Ministry of Education and Research (Bundesministerium für Bildung und Forschung [BMBF]) (Germany) (grant ref: 01GL0509)

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Dr Werner Kissling
Scientific

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

Primary study design	Interventional
Study design	Randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	How can rehospitalisations of patients with schizophrenia be avoided? A comparison between different compliance programs
Study objectives	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(s)	Approval received from the local ethics committee on the 10th February 2006 (ref: 1468/06).
Health condition(s) or problem(s) studied	Schizophrenia or schizoaffective disorder
Intervention	1. Psychoeducation by professionals 2. Psychoeducation by peer-moderators 3. Video-education
Intervention type	Other
Primary outcome measure(s)	Rehospitalisation rate
Key secondary outcome measure(s)	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])
Completion date	31/12/2007

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Upper age limit	67 Years
Sex	Not Specified
Target sample size at registration	896
Key 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
Key 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
Date of first enrolment	01/09/2006
Date of final enrolment	31/12/2007

Technical University Munich

Muenchen
81675
Germany

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

01/02/2019: No publications found, verifying results with the principal investigator