NCT00514423

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
896

participants targeted

Target at P75+ for not_applicable schizophrenia

Timeline
Completed

Started Sep 2006

Longer than P75 for not_applicable schizophrenia

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2006

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

August 9, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 10, 2007

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

August 29, 2014

Status Verified

August 1, 2014

Enrollment Period

5.3 years

First QC Date

August 9, 2007

Last Update Submit

August 28, 2014

Conditions

SchizophreniaSchizoaffective Disorder

Outcome Measures

Primary Outcomes (1)

  • Rehospitalisation rate

Secondary Outcomes (9)

  • Rehospitalisation days

  • Resulting costs per patient

  • Compliance

  • Knowledge of illness

  • Attitude towards illness

  • +4 more secondary outcomes

Study Arms (4)

2

EXPERIMENTAL

Psychoeducation by peer-moderators

Other: Psychoeducation by peer-moderators

1

EXPERIMENTAL

Psychoeducation by professionals

Other: Psychoeducation by professonals

3

EXPERIMENTAL

Video-education

Other: Video-education

4

PLACEBO COMPARATOR

Control group

Other: Noneducational video group (control group)

Interventions

Psychoeducation by professonalsOTHER
1
Psychoeducation by peer-moderatorsOTHER
2
Video-educationOTHER
3
Noneducational video group (control group)OTHER
4

Eligibility Criteria

Age18 Years - 67 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Schizophrenia or schizoaffective disorder (ICD-10)
  • Age 18 to 67 years
  • Hospitalised or treated in day care clinic

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

München, 81675, Germany

Location

MeSH Terms

Conditions

SchizophreniaPsychotic Disorders

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Werner Kissling, MD

    Technical University of Munich

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

August 9, 2007

First Posted

August 10, 2007

Study Start

September 1, 2006

Primary Completion

December 1, 2011

Study Completion

December 1, 2011

Last Updated

August 29, 2014

Record last verified: 2014-08

Locations

DE(1)