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 number | NCT00514423 |
| Secondary identifying numbers | 01GL0509 |
- Submission date
- 02/11/2006
- Registration date
- 14/02/2007
- Last edited
- 01/02/2019
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
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
Contact information
Dr Werner Kissling
Scientific
Scientific
Technical University Munich
Klinikum rechts der Isar
Department of Psychiatry and Psychotherapy
Moehlstrasse 26
Muenchen
81675
Germany
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| 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 | 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 study start date | 01/09/2006 |
| Completion date | 31/12/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 67 Years |
| Sex | Not Specified |
| Target number of participants | 896 patients, family members as available |
| 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 |
Locations
Countries of recruitment
- Germany
Study participating centre
Technical University Munich
Muenchen
81675
Germany
81675
Germany
Sponsor information
Technical University Munich (Germany)
University/education
University/education
Klinikum rechts der Isar
Department of Psychiatry and Psychotherapy
Moehlstrasse 26
Muenchen
81675
Germany
| Website | http://www.tum.de/ |
|---|---|
"ROR" |
https://ror.org/02kkvpp62 |
Funders
Funder type
Government
Federal Ministry of Education and Research (Bundesministerium für Bildung und Forschung [BMBF]) (Germany) (grant ref: 01GL0509)
Government organisation / National government
Government organisation / National government
- Alternative name(s)
- Federal Ministry of Education and Research, BMBF
- Location
- Germany
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
01/02/2019: No publications found, verifying results with the principal investigator
