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| [ ...Back to search results ] | [ Print-friendly version ] |
| Occupational orientation in medical neurorehabilitation (Berufliche Orientierung in der Medizinischen Neurorehabilitation [BOMeN]) |
| ISRCTN | ISRCTN25515380 |
| ClinicalTrials.gov identifier | |
| Public title | Occupational orientation in medical neurorehabilitation (Berufliche Orientierung in der Medizinischen Neurorehabilitation [BOMeN]) |
| Scientific title | |
| Acronym | BOMeN |
| Serial number at source | GfR 06/006 |
| Study hypothesis |
The trial studies survivors of stroke or brain injury with a special occupational difficulty concerning the reintegration to work. For these patients return-to-work is accompanied by explicit strains because of the coincidence of physical and cognitive impairments. Furthermore patients with acquired brain injury often focus only on the physical deficits and do not show adequate awareness for cognitive constraints.
Hypotheses: 1. Until 15 months after rehabilitation the ratio of (re-)employed persons in the intervention group is significantly higher than the ratio of (re-)employed persons in the control group 2. Until 15 months after rehabilitation the ratio of (re-)employable persons in the intervention group is significantly higher than the ratio of (re-)employable persons in the control group 3. Patients of the intervention group can be re-integrated significantly quicker than patients of the control group 4. Re-integrated patients who participated in the intervention group show significantly less days of incapacity for work than re-integrated patients who participated in the control group 5. Patients who participated in the intervention group show a significantly higher satisfaction with life and health than patients who participated in the control group 6. Patients who participated in the intervention group show a significantly higher motivation for rehabilitation than patients who participated in the control group 7. The intervention treatment will gain a higher valuation than the control treatment by the parties involved (patients and rehabilitation workers) |
| Lay summary | |
| Ethics approval | Ethics Committee of the Arztekammer Westfalen-Lippe and the Medical Faculty of the Westfalischen Wilhelms Unitersigy of Munster. Approved on 24th May 2007 (ref: 2007-235-f-S) |
| Study design | Randomised controlled trial. |
| Countries of recruitment | Germany |
| Disease/condition/study domain | Neurorehabilitation for survivors of stroke and brain injury |
| Participants - inclusion criteria |
All participants must meet all of the following conditions:
1. Positive prognostic estimation of occupational ability 2. Stroke or craniocerebral trauma 3. Estimated Functional Independence Measure (FIM) greater than or equal to 90 Also, all participants must meet at least one of the following conditions: 1. Advice for medical rehabilitation based on paragraph 51.1 of the Social Security Statutes, Book No. 5 (SGB V) 2. Inability to work for 3 months during the last 12 months 3. Ability to work is less than 6 hours 4. Not in paid work before start of rehabilitation 5. Necessary occupational reorientation 6. Application for a pension 7. Risk of early retirement |
| Participants - exclusion criteria |
1. Older than 60 years
2. Acute psychiatric disorder 3. Acute addiction 4. Restrictive aphasic disorder 5. Insufficient knowledge of German language 6. Estimated FIM <90 7. Neurological diseases other than stroke or craniocerebral trauma |
| Anticipated start date | 01/07/2007 |
| Anticipated end date | 30/06/2010 |
| Status of trial | Completed |
| Patient information material | |
| Target number of participants | 306 |
| Interventions |
Intervention group: Patients of the intervention group take part in a newly developed rehabilitation concept called Occupational Orientation in Medical Neurorehabilitation (BOMeN) which consists of nine sessions of 3 hours during a 4-week rehabilitation. In this therapy the patients get to know relevant information about stress, perspectives, motivation and the relevance of attention, memory, planning functions and motor skills for everyday working life. The contents are mediated by patient education, experiments of perception and ergotherapeutic exercises. Furthermore the neuropsychological, socialmedical and ergotherapeutical assessments are more related to work and therapy is integrated in a fixed schedule. Finally different disciplines show a higher degree of interworking.
Control group: Medical Neurorehabilitation (MeN) patients of the control group take part in the conventional rehabilitation concept (MeN) which contains shorter units of assessment and therapy without an explicit relation to work. The average duration of treatment in both groups is controlled. |
| Primary outcome measure(s) |
The following variables are measured by standardized or self-developed questionnaires:
1. Re-employment (patients) 15 months after rehabilitation 2. (Re-)employability (patients) 15 months after rehabilitation 3. Days of incapacity to work (patients), measured using the Indicators of the Status of Rehabilitation questionnaire (Indikatoren des Reha-Status [IRES]) 15 months after rehabilitation 4. Expectations concerning the rehabilitation (patients), measured using the Questionnaire on Expectations and Motivation Concerning Rehabilitation (Fragebogen zu Reha-Erwartungen und Reha-Motivation [FREM]) at the start and end of rehabilitation 5. Motivation for rehabilitation (patients), measured using the Diagnostic Investigation of Motivation Concerning Work questionnaire (Diagnostik von Arbeitsmotivation [DIAMO]) at the start and end of rehabilitation, 6, 12 and 15 months after rehabilitation 6. Satisfaction with life and health (patients) (the 36-item Short Form health survey [SF-36]/the World Health Organization Quality of Life Questionnaire [WHO-QoL-BREF]) at the start and end of rehabilitation, 6, 12 and 15 months after rehabilitation 7. Satisfaction with rehabilitation procedure and contents (patients and rehabilitation workers). Timepoints for patients: at the start and end of rehabilitation, 6, 12 and 15 months after rehabilitation. Timepoints for workers: once in Summer 2008. |
| Secondary outcome measure(s) |
1. Cognitive functional status at the start and end of rehabilitation, 6, 12 and 15 months after rehabilitation
2. Motivation for work at the start and end of rehabilitation, 6, 12 and 15 months after rehabilitation |
| Sources of funding |
1. Association for Rehabilitation Sciences Nordrhein-Westfalen e.V. (Gesellschaft für Rehabilitationswissenschaften Nordrhein-Westfalen e.V.) (ref: GfR 06006 / 623-06)
2. Houses of Holy Order of Johanniter Rehabilitation Centre (Johanniter-Ordenshäuser Bad Oeynhausen gemGmbH) (ref: BOMeN 98410) |
| Trial website | |
| Publications | |
| Contact name | Dr Anke Menzel-Begemann |
| Address | Johanniterstrasse 7 |
| City/town | Bad Oeynhausen |
| Zip/Postcode | 32545 |
| Country | Germany |
| Tel | +49 5731 151 773 |
| anke.menzel-begemann@ahb-klinik.de | |
| Sponsor | Association for Rehabilitation Sciences Nordrhein-Westfalen e.V. (Germany) |
| Address | Königsallee 71 |
| City/town | Düsseldorf |
| Zip/Postcode | 40215 |
| Country | Germany |
| Sponsor website: | http://www.rehaforschung-nrw.de |
| Date applied | 29/08/2007 |
| Last edited | 03/10/2007 |
| Date ISRCTN assigned | 03/10/2007 |
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