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| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | April 16, 2007 | ||||
| Last Updated Date | April 16, 2007 | ||||
| Start Date ICMJE | April 2003 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE |
sucessful employment for one day in the open labour market | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | The Effectiveness of Supported Employment for People With Severe Mental Illness: an RCT in Six European Countries | ||||
| Official Title ICMJE | Enhancing the Quality of Life and Independence of Persons Disabled by Severe Mental Illness Through Supported Employment | ||||
| Brief Summary | The primary aim of the study was to determine the effectiveness of a form of supported employment, Individual Placement and Support (IPS) compared to existing good quality rehabilitation and vocational services for people with psychotic illnesses in terms of ‘open’ employment outcomes (in the competitive labour market), and to examine its relative effectiveness in the context of different European welfare systems and labour markets. The primary hypothesis was that IPS patients would be more likely to obtain open employment than control service patients. Secondary hypotheses were that they would be in open employment for longer than the control patients, and that they would not spend more time in hospital. |
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| Detailed Description | An RCT was conducted in six European centres: London (UK), Ulm-Guenzburg (Germany), Rimini (Italy), Zurich (Switzerland), Groningen (the Netherlands) and Sofia (Bulgaria). Patients were included if they had a diagnosis of SMI (psychotic illness including bipolar disorder), were aged 18 to retirement age, had been ill and had major role dysfunction for at least two years, were living in the community at baseline, had not been in competitive employment in the preceding year and expressed the desire to enter competitive employment. They were randomly allocated to receive either IPS or the ‘Vocational Service’ (control service). Given the need to consider the impact of gender and work history on vocational outcomes (20), service allocation was stratified by centre, gender and work history (more or less than a month’s competitive employment in the five years prior to baseline). Randomisation was conducted centrally using MINIM Version 1.5. A researcher at each centre recruited the patients, submitted them to the statistician for randomisation and received the allocation by email. The allocation sequence was concealed until the services had been assigned, but it was not possible for patients, professionals or researchers to be blind to service allocation thereafter. |
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| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Open Label, Active Control, Single Group Assignment, Efficacy Study | ||||
| Condition ICMJE | Psychosis | ||||
| Intervention ICMJE | Procedure: Individual placement and support (vocational rehabilitation) | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | Burns T, Catty J, Becker T, Drake RE, Fioritti A, Knapp M, Lauber C, Rossler W, Tomov T, van Busschbach J, White S, Wiersma D; EQOLISE Group. The effectiveness of supported employment for people with severe mental illness: a randomised controlled trial. Lancet. 2007 Sep 29;370(9593):1146-52. | ||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 300 | ||||
| Completion Date | November 2005 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria: - |
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| Gender | Both | ||||
| Ages | 18 Years to 55 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United Kingdom | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00461318 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | QLRT-2001-00683 | ||||
| Study Sponsor ICMJE | University of Oxford | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | University of Oxford | ||||
| Verification Date | April 2007 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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