Condition category
Nervous System Diseases
Date applied
20/03/2012
Date assigned
08/05/2012
Last edited
19/09/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
For most people the ability to go back to work after severe illness is very important. But for persons with acquired brain damage this is an enormous challenge, even for those who are less impaired in their functional abilities and whose restrictions initially appear less relevant. These patients often leave the rehab hospital expecting that they will be directly able to carry on like before. However, they too usually meet difficulties in everyday life. Studies have identified two relevant approaches in rehabilitation: the program should be as close to reality as possible and it should include patient education. Therefore, a new and potentially more effective rehabilitation program has been developed in order to prepare people for return to everyday life and work. This program includes work simulation: and psycho-educational lessons. The work simulation is similar to the patient’s usual individual working conditions. This way, patients can test their work-related abilities and deficits. In the psycho-educational lessons the patients are given the chance to talk about their experiences during the work simulation and their difficulties, and they can learn how to cope with everyday work life. The aims of this study are to investigate if the new rehabilitation program (BoReM-N) is more effective than the usual programs. The question is whether it helps patients to return to work and to everyday life.

Who can participate?
Study participants have neurological diseases, are younger than 61 years, and have the capability to go back to work.

What does the study involve?
Participants are randomly assigned either to the new program (BoReM-N) or to usual care. Contrary to current programs, the new rehabilitation program is orientated towards the everyday working world. It contains work simulations and work-related psycho-educational lessons. The patients receive handouts with key information from the lessons. At the beginning and at the end of the rehabilitation stay and 6,12 and 15 months thereafter, participants have to complete questionnaires. In these questionnaires participants are able to give feedback about the return to everyday life and to work.

What are the possible benefits and risks of participating?
The potential benefit for participants is a better preparation for return to work and everyday life. There are no known risks of participating.

Where is the study run from?
The study takes place at this two neurological rehabilitation centers in western Germany:
Johanniter-Ordenshäuser Bad Oeynhausen gemGmbH, Neurologisches Rehabilitationszentrum Godeshöhe - Bonn Bad Godesberg.

When is the study starting and how long is it expected to run for?
Patients are enrolled in the study between January 2011 and May 2012. Follow-up examinations will continue until September 2013.

Who is funding the study?
Gesellschaft für Rehabilitationswissenschaften Nordrhein-Westfalen (GfR-NRW e.V.) .

Who is the main contact?
Dr Anke Menzel-Begemann
anke.menzel-begemann@uni-bielefeld.de 

Trial website

http://www.uni-bielefeld.de/gesundhw/ag6/projekte/berufliches%20reha-modul.html

Contact information

Type

Scientific

Primary contact

Dr Anke Menzel-Begemann

ORCID ID

Contact details

University of Bielefeld
School of Public Health
Department of Public Health Nursing & Health Sciences Research
Universitätsstr. 25
Bielefeld
33615
Germany
+49 521 106 4818
anke.menzel-begemann@uni-bielefeld.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

GfR09003 / 623 - 10

Study information

Scientific title

Effect of work simulation modules compared to usual care on return to work in medical rehabilitation for patients with neurological diseases

Acronym

BoReM-N

Study hypothesis

To evaluate return to work and patient-related outcomes of the new rehabilitation program (BoReM-N) compared to the current traditional rehabilitation programs.

The trial studies survivors of neurological diseases 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, cognitive and language impairments. Furthermore, patients with acquired brain injury often focus only on the physical deficits and don't show adequate awareness for cognitive and language constraints - especially might ones.

Ethics approval

Ethics Committee of the Medical Association of Westfalen-Lippe and the Medical Faculty of the Westfälische Wilhelms University of Muenster, 28/09/2010, ref: 2010-345-f-S
[Ethik-Kommission der Ärztekammer Westfalen-Lippe und der Medizinischen Fakultät der Westfälischen Wilhelms-Universität Münster]

Study design

Randomised controlled clinical interventional multicentre study

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Neurological diseases

Intervention

1. Intervention group = BoReM-N
Patients of the intervention group take part in a new developed reha-concept called BoReM-N (work simulation modules in the context of occupational orientation in medical neurorehabilitation), which consists of six psychoeducational sessions of 2 hours during a 3-week rehabilitation and three work simulation sessions of 3 hours. In the first run of the work simulation the patients are to be observed while trying to do work-related jobs. The second and third time the work simulation runs under therapeutic perspective. In this therapy - added by the educational sessions - the patients get to know relevant information about stress, perspectives, realistic aims and the relevance of cognitive, language and motor skills for everyday working life. Furthermore, the neuropsychological, socialmedical and ergotherapeutical single assessments are more related to work and assessment and therapy is integrated in a semi-fixed schedule. Finally the different disciplines show an higher degree of interworking.

2. Control group = MeN
Patients of the control group take part in the conventional reha-concept which contains shorter units of assessment and therapy without an explicit relation to work.

The average number of minutes of treatment in both groups is controlled.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

The following variables are measured by standardized or self-developed questionnaires:
1. Re-employment
2. (Re-)employability
3. Days of incapacity to work (IRES)

Secondary outcome measures

The following variables are measured by standardized or self-developed questionnaires:
1. Expectations concerning the rehabilitation (FREM)
2. Satisfaction with life and health (SF-36/WHO-QoL-BREF)
3. Satisfaction with rehabilitation procedure and contents

Overall trial start date

10/01/2011

Overall trial end date

28/09/2013

Reason abandoned

Eligibility

Participant inclusion criteria

1. Necessary condition:
1.1. Neurological disease
1.2. Positive prognostic estimation of occupational ability
1.3. Estimated FIM =/> 90
2. Sufficient condition:
2.1. Advice for medical rehabilitation based on §51.1 SGB V
2.2. Inability to work for 3 months during the last 12 months
2.3. Ability to work is less than 6 hours
2.4. Inoccupation before start of rehabilitation
2.5. Necessary occupational reorientation
2.6. Application for a pension
2.7. Risk of early retirement

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

304

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

Recruitment start date

10/01/2011

Recruitment end date

28/09/2013

Locations

Countries of recruitment

Germany

Trial participating centre

University of Bielefeld
Bielefeld
33615
Germany

Sponsor information

Organisation

Rehabilitation Research of North Rhine-Westphalia (Germany)

Sponsor details

[Gesellschaft für Rehabilitationswissenschaften Nordrhein-Westfalen e.V.]
Garstenstraße 194
Münster
48147
Germany
+49 521 238 2631
info@rehaforschungs-nrw.de

Sponsor type

Hospital/treatment centre

Website

http://www.rehaforschung-nrw.de/rehawissen_start/index.php

Funders

Funder type

Hospital/treatment centre

Funder name

Gesellschaft für Rehabilitationswissenschaften Nordrhein-Westfalen [GfR] (Germany), ref: GfR09003 / 623 - 10

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Johanniter-Ordenshäuser Bad Oeynhausen gemGmbH (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Universität Bielefeld (Germany), ref: PSP - D - 3510 - 0006 - 0013 - 5000

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

Publication citations

Additional files

Editorial Notes