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Assertive outreach for people with schizophrenia in Germany
ISRCTN ISRCTN34900108
DOI 10.1186/ISRCTN34900108
ClinicalTrials.gov identifier
EudraCT number
Public title Assertive outreach for people with schizophrenia in Germany
Scientific title Comparing assertive outreach with standard care for people with schizophrenia in Germany: health care utilization, psychopathology and level of functioning after 12 months
Acronym N/A
Serial number at source DRKS00003351
Study hypothesis 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.
Lay summary Lay summary under review 2
Ethics approval Ethics Commission & Medical Association in Lower Saxony (Ethikkommission bei der Ärztekammer Niedersachsen) 14 March 2011, ref: Bo/03/2011
Study design Multi-centred naturalistic quasi-randomised controlled trial
Countries of recruitment Germany
Disease/condition/study domain Schizophrenia
Participants - inclusion criteria 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)
Participants - exclusion criteria 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
Anticipated start date 03/05/2011
Anticipated end date 31/03/2013
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 536
Interventions 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
Primary outcome measure(s) 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).
Secondary outcome measure(s) 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
Sources of funding 1. European Funds for Regional Development (Germany)
2. Federal State of Lower Saxony (Germany)
3. Innovation-Incubator, Leuphana University Lueneburg (Germany)
Trial website
Publications 1. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/23414234
Contact name Prof  Wulf  Roessler
  Address Volgershall 1
  City/town Lueneburg
  Zip/Postcode 21339
  Country Germany
  Tel +49 (0)413 1677 5581
  Email roessler@dgsp.uzh.ch
Sponsor European Fund for Regional Development (Germany)
  Address Friedrichswall 1
  City/town Hannover
  Zip/Postcode 30159
  Country Germany
  Sponsor website: http://www.efre.niedersachsen.de
Date applied 01/12/2011
Last edited 22/02/2013
Date ISRCTN assigned 27/01/2012
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