Contact information
Type
Scientific
Primary contact
Dr Anke Menzel-Begemann
ORCID ID
Contact details
Johanniterstrasse 7
Bad Oeynhausen
32545
Germany
+49 5731 151 773
anke.menzel-begemann@ahb-klinik.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
GfR 06/006
Study information
Scientific title
Acronym
BOMeN
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)
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.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Neurorehabilitation for survivors of stroke and brain injury
Intervention
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.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
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 measures
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
Overall trial start date
01/07/2007
Overall trial end date
30/06/2010
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
306
Participant 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
Recruitment start date
01/07/2007
Recruitment end date
30/06/2010
Locations
Countries of recruitment
Germany
Trial participating centre
Johanniterstrasse 7
Bad Oeynhausen
32545
Germany
Sponsor information
Organisation
Association for Rehabilitation Sciences Nordrhein-Westfalen e.V. (Germany)
Sponsor details
Königsallee 71
Düsseldorf
40215
Germany
Sponsor type
Not defined
Website
Funders
Funder type
Hospital/treatment centre
Funder name
Association for Rehabilitation Sciences Nordrhein-Westfalen e.V. (Gesellschaft für Rehabilitationswissenschaften Nordrhein-Westfalen e.V.) (ref: GfR 06006 / 623-06)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Houses of Holy Order of Johanniter Rehabilitation Centre (Johanniter-Ordenshäuser Bad Oeynhausen gemGmbH) (ref: BOMeN 98410)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary