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17 May 2012
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| [ Print-friendly version ] |
| Improving the diagnostic procedure for injured patients - Optimization for the questionnaire "Fragebogen Arbeit und Befinden" (OptiFAB) [Diagnostik der Unfallbetroffenen der Suva] |
| ISRCTN | ISRCTN05534684 |
| ClinicalTrials.gov identifier | |
| Public title | Improving the diagnostic procedure for injured patients - Optimization for the questionnaire "Fragebogen Arbeit und Befinden" (OptiFAB) [Diagnostik der Unfallbetroffenen der Suva] |
| Scientific title | Improving the diagnostic procedure for injured patients: a randomised controlled trial |
| Acronym | OptiFAB |
| Serial number at source | OptiFAB |
| Study hypothesis |
1. A significant difference in psychological and work-related outcome is expected between groups (OptiFAB and FABpur). Specifically, it is assumed that the group with the psychological and / or work-related intervention will have better outcomes in terms of psychological functioning (well-being) and a faster reintegration into the workplace.
2. A difference in term of a better triage is expected between groups (FABplus and FABpur). As above, it is assumed that the group with a GAS training and a manual will have better and faster triage process. |
| Lay summary | Lay summary under review |
| Ethics approval | Philosophical - Human Sciences Faculty Ethics Commission of Bern (Switzerland) approved on 8 June 2011, ref: 2011-04-172 |
| Study design | Blinded randomized experimental intervention study |
| Countries of recruitment | Switzerland |
| Disease/condition/study domain | Different disabilities after an accident in the area workplace or / and mental health |
| Participants - inclusion criteria |
Patients 8 weeks after an accident have to fullfil followed criteria:
1. Approved accident or occupational disease 2. Unlimited employment contract 3. There must be at least 90 days or more between accident data and employment date 4. NCM-Code > 1 5. Present inability to work 6. No unemployment 7. No full working capacity in the next two weeks 8. Identified as a potential complex case by the questionnaire Arbeit und Befinden (FAB) 9. Able to speak German |
| Participants - exclusion criteria |
1. Inability to communicate or lack of language skills
2. Limited employment contract 3. Between accident data and employment date are less than 90 days 4. NCM-Code < 1 5. Ability to work 6. Unemployment 7. Full working capacity in the next two weeks 8. No complex case 9. Under 18 years of age 10. Not willing to participate in the study |
| Anticipated start date | 01/09/2011 |
| Anticipated end date | 31/12/2013 |
| Status of trial | Ongoing |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet [in German] |
| Target number of participants | For each group 100 participants and a total of 400 participants. |
| Interventions |
OptiFAB: Psychological intervention or / and work related intervention and Control group
Treatment arm OptiFAB: The intervention consists of 10-20 weekly sessions: structured setting and a combination of educational and supportive coaching elements. FABplus: Improvement of triage process. A group of case manager receives a "Goal attainment Scale" training and a manual (summarized "the good practice" to faster the triage process) FABpur: Treatment as usual |
| Primary outcome measure(s) |
1. Psychological well-being: BFW/E (Berner Fragebogen zum Wohlbefinden, Grob et al., 1991; 39 Items). Data collected 8 weeks after the accident.
2. Work related satisfaction: General job satisfaction (Baillod & Semmer, 1994, 4 Items). Data collected 8 weeks after the accident. 3. Return to the workplace |
| Secondary outcome measure(s) |
1. Psychosocial conditions and health:
1.1. Subjective Happiness Scale (SHS, Lyubomirsky & Lepper, 1999, 4 Items)] 1.2. Social support (SALSA, Skala zur Erfassung der sozialen Unterstützung am Arbeitsplatz, IRES-3) 1.3. Fear-Avoidance Beliefs questionnaire (FABQ-d, Staerkle et al, 2004, 16 Items) 2. Coping, self-efficacy, optimism: 2.1. CISS (short version, Kälin, 2003, 19 Items) 2.2. SWE (Selbstwirksamkeit, Schwarzer, 1993, 10Items) 2.3. LOT-R (Optimism, Glaesmer & Hoyer, 2003, 10 Items) Data collected 8 weeks after the accident |
| Sources of funding |
SUVA (Switzerland)
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| Trial website | |
| Publications | |
| Contact name | Prof Hansjörg Znoj |
| Address |
Institute of Psychology
Department of Clinical Psychology and Psychotherapy University of Bern Gesellschaftsstrasse 49 |
| City/town | Bern |
| Zip/Postcode | 3012 |
| Country | Switzerland |
| Tel | +41 31 631 45 91 |
| Fax | +41 31 631 41 55 |
| hansjoerg.znoj@psy.unibe.ch | |
| Sponsor | SUVA (Switzerland) |
| Address |
Postfach
Fluhmattstrasse 1 |
| City/town | Luzern |
| Zip/Postcode | 6002 |
| Country | Switzerland |
| vmd.bereich@suva.ch | |
| Sponsor website: | http://www.suva.ch/english/ |
| Date applied | 18/08/2011 |
| Last edited | 08/12/2011 |
| Date ISRCTN assigned | 08/12/2011 |
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| © 2012 ISRCTN unless otherwise stated. | |
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