Assertive Community Treatment (ACT) as Part of Integrated Care Versus Standard Care: a 12-month Trial in Patients With First- and Negatively Selected Multiple-episode Schizophrenia-spectrum Disorders Treated With Quetiapine IR
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Schizophrenia
- Sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Time to Service Disengagement
- Status
- Completed
- Last Updated
- 16 years ago
Overview
Brief Summary
The study examined the 12-month effectiveness of continuous therapeutic assertive community treatment (ACT) as part of integrated care (IC) compared to standard care (SC) in a catchment area comparison design in patients with schizophrenia spectrum disorders (SSD) treated with quetiapine IR.
Detailed Description
Two catchment areas in Hamburg, Germany with similar population size and health care structures were assigned to offer 12-month ACT (\& IC; Department of Psychiatry and Psychotherapy, University Medical Center Hamburg-Eppendorf) or SC (Asklepios Hospital, Department of Psychiatry and Psychotherapy) to 120 first-episode and negatively selected multiple-episode patients with SSD. Primary outcome was the time to Service Disengagement. Secondary outcomes comprised medication non-adherence, improvements of symptoms, functioning, quality of life, satisfaction with care from patients and relatives perspectives, and service use data.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age 18-65 years
- •Met the diagnostic criteria of a first- or multiple episode of a schizophrenia spectrum disorders, i.e. schizophrenia, schizophreniform disorder, schizoaffective disorder, delusional disorder, or psychotic disorder NOS
- •New initiation or current treatment with quetiapine Immediate Release (IR)
Exclusion Criteria
- •Other psychotic disorders (e.g., due to medical condition)
- •Mental retardation (IQ lower than 70 points)
Outcomes
Primary Outcomes
Time to Service Disengagement
Time Frame: 12 months
The primary outcome of the study was the time to service disengagement (SD). This primary aim was chosen because the assertive approach of ACT is to prevent service disengagement3 and because service disengagement is a major predictor for relapse and thereby poor long-term outcome.16,17 Service disengagement was present, if a patient repeatedly refuses further treatment despite several attempts of reengagement (phone calls of patient and family in both treatment arms and potentially home visits in the ACT group).
Secondary Outcomes
- Improvements of symptoms, functioning, quality of life, and satisfaction with care from patients and relatives perspectives(12 months)