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ISRCTN
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ISRCTN34900108
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ClinicalTrials.gov identifier
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Public title
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Assertive outreach for people with schizophrenia in Germany
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Scientific title
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Comparing assertive outreach with standard care for people with schizophrenia in Germany: health care utilization, psychopathology and level of functioning after 12 months
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Acronym
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N/A
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Serial number at source
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DRKS00003351
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Study hypothesis
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Assertive outreach (AO) is superior to standard care for people with schizophrenia. Patients receiving assertive outreach use significantly fewer days of inpatient treatment than patients receiving standard care. In addition, AO leads to better clinical and functional outcomes, to greater patient satisfaction with care and lower health care costs compared to standard care.
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Lay summary
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Lay summary under review 2
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Ethics approval
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Ethics Commission & Medical Association in Lower Saxony (Ethikkommission bei der Ärztekammer Niedersachsen) 14 March 2011, ref: Bo/03/2011
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Study design
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Multi-centred naturalistic quasi-randomised controlled trial
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Countries of recruitment
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Germany
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Disease/condition/study domain
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Schizophrenia
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Participants - inclusion criteria
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We include adult patients (18 years or older) with a clinical diagnosis of schizophrenia (F20) and moderate or severe impairments in the level of functioning rated by the physician using the global assessment of function scale (Global Assessment of Functioning (GAF) ≤ 60)
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Participants - exclusion criteria
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1. Patients with medium or severe cognitive impairments or organic mental disorder
2. Patients with insufficient language ability
3. Individuals who are unwilling or unable to give informed consent to the study participation
4. Patients who refuse Assertive Outreach
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Anticipated start date
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03/05/2011
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Anticipated end date
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31/03/2013
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Status of trial
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Ongoing |
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Patient information material
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Not available in web format, please use the contact details below to request a patient information sheet
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Target number of participants
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536
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Interventions
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1. Assertive Outreach (with home care and case management provided by a mental health nurse, a 24-hour, seven days a week available crisis service, psychoeducation, an evidence informed treatment guideline and a strong collaboration between the psychiatrist and ambulatory nursing service)
2. Treatment as usual
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Primary outcome measure(s)
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Number of days spent in inpatient psychiatric care measured with the German version of the Client Socio-demografic and Service Receipt Inventory (CSSRI, interview with the patient) at baseline (t0) and every three month within 1 year (t1-t4).
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Secondary outcome measure(s)
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1. Psychosocial functioning measured with the WHO-Disability Assessment Scale II (patient rating) and the Global Assessment of Functioning (physician rating) at baseline (t0) and after 6 month and 12 month (t2 and t4)
2. Psychopathology measured with the Brief Psychiatric Rating Scale (physician rating) and a 2-item-version of the Alcohol Use and Drug Use Scale (patient rating) at t0, t2 and t4
3. Life satisfaction measured with single item (11-point scale, patient rating) at t0, t2 and t4
4. Patient satisfaction with care measured with the short version of the Patient Assessment of Chronic Care (patient rating) at t0, t2 and t4
5. Direct and indirect costs measured with the CSSRI (interview) at t0-t4
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Sources of funding
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1. European Funds for Regional Development (Germany)
2. Federal State of Lower Saxony (Germany)
3. Innovation-Incubator, Leuphana University Lueneburg (Germany)
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Trial website
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Publications
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Contact name
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Prof
Wulf
Roessler
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Address
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Volgershall 1
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City/town
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Lueneburg
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Zip/Postcode
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21339
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Country
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Germany
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Tel
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+49 (0)413 1677 5581
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Email
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roessler@dgsp.uzh.ch
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Sponsor
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European Fund for Regional Development (Germany)
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Address
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Friedrichswall 1
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City/town
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Hannover
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Zip/Postcode
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30159
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Country
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Germany
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Sponsor website:
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http://www.efre.niedersachsen.de
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Date applied
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01/12/2011
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Last edited
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27/01/2012
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Date ISRCTN assigned
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27/01/2012
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