SchizophreniaNCT00514423
How Can Rehospitalisations of Patients With Schizophrenia be Avoided? A Comparison Between Different Compliance Programs
A study testing Psychoeducation by professonals, Psychoeducation by peer-moderators and Video-education in people with Schizophrenia and Schizoaffective Disorder, run by Technical University of Munich at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 67 years
- Conditions the study is for
- Schizophrenia, Schizoaffective Disorder
- What is being tested?
- Psychoeducation by professonals, Psychoeducation by peer-moderators and Video-education
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 896 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2006to Dec 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 67 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Schizophrenia or schizoaffective disorder (ICD-10)
- Age 18 to 67 years
- Hospitalised or treated in day care clinic
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Klinik und Poliklinik für Psychiatrie und Psychotherapie am Klinikum rechts der Isar der Technischen Universität München
München, 81675
About this study
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.
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Being tested
- Psychoeducation by professonals, Psychoeducation by peer-moderators, Video-education, Noneducational video group (control group)
- Medical subject headings
- Schizophrenia, Psychotic Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychoeducation by professonalsOther
Psychoeducation by peer-moderatorsOther
Video-educationOther
Noneducational video group (control group)Other
| Study group | Role | What they receive |
|---|---|---|
| 2 | Experimental | Psychoeducation by peer-moderators Receives: Other: Psychoeducation by peer-moderators |
| 1 | Experimental | Psychoeducation by professionals Receives: Other: Psychoeducation by professonals |
| 3 | Experimental | Video-education Receives: Other: Video-education |
| 4 | Placebo comparator | Control group Receives: Other: Noneducational video group (control group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rehospitalisation rate
Secondary outcomes (9)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2007 (estimated)
- Study startSep 2006
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- More trials run by Technical University of MunichThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 896 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Technical University of Munich
- Sponsor type
- University, hospital or other
- Investigators
- Werner Kissling, MD, Principal investigator, Technical University of Munich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00514423
- Sponsor's protocol ID
- 01GL0509
- Other IDs
- ISRCTN19638644
- Status last verified
- Aug 2014
- First submitted
- 9 Aug 2007
- Last updated
- 29 Aug 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How Can Rehospitalisations of Patients With Schizophrenia be Avoided? A Comparison Between Different Compliance Programs
- ClinicalTrials.gov ID
- NCT00514423
- Acronym / sponsor ID
- 01GL0509
- Conditions
- Schizophrenia, Schizoaffective Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 896 participants (estimated)
- Lead sponsor
- Technical University of MunichUniversity, hospital or other
- Study start
- Sep 2006
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 10 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 2 | Experimental | Other: Psychoeducation by peer-moderatorsPsychoeducation by peer-moderators |
| 1 | Experimental | Other: Psychoeducation by professonalsPsychoeducation by professionals |
| 3 | Experimental | Other: Video-educationVideo-education |
| 4 | Placebo comparator | Other: Noneducational video group (control group)Control group |
Who may qualify
- Ages
- 18 to 67 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Schizophrenia or schizoaffective disorder (ICD-10)
- Age 18 to 67 years
- Hospitalised or treated in day care clinic
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Psychoeducation by professonals | Other | 1 |
| Psychoeducation by peer-moderators | Other | 2 |
| Video-education | Other | 3 |
| Noneducational video group (control group) | Other | 4 |
Primary outcome
Rehospitalisation rate
9 secondary outcomes
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Werner Kissling, MD principal investigator
Technical University of Munich
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychoeducation by professonals, Psychoeducation by peer-moderators and Video-education in people with Schizophrenia and Schizoaffective Disorder, run by Technical University of Munich at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rehospitalisation rate. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Aug 2014.