Assertive outreach for people with schizophrenia in Germany

• Register: ISRCTN
• Last refreshed on: 8 May 2017
• Main ID: ISRCTN34900108
• Date of registration: 27/01/2012
• Prospective Registration: No
• Primary sponsor: European Fund for Regional Development (Germany)
• 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
• Date of first enrolment: 03/05/2011
• Target sample size: 536
• Recruitment status: Completed
• URL: http://isrctn.com/ISRCTN34900108
• Study type: Interventional
• Study design: Multi-centred naturalistic quasi-randomised controlled trial (Treatment)
• Phase: Not Applicable

Countries of recruitment

Germany

Contacts

• Name: Wulf Roessler

Key inclusion & exclusion criteria

Inclusion criteria: 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)
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

Age minimum:
Age maximum:
Gender: Both

Health Condition(s) or Problem(s) studied

Schizophrenia
Mental and Behavioural Disorders
Schizophrenia

Intervention(s)

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(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(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

Secondary ID(s)

DRKS00003351

Source(s) of Monetary Support

European Funds for Regional Development (Germany), Federal State of Lower Saxony (Germany), Innovation-Incubator, Leuphana University Lueneburg (Germany)