Evidence-Based Self-management In Multiple Sclerosis (EBSIMS). A multi-centre, randomised controlled trial to investigate the effects of a structured educational programme on relapse management in Multiple Sclerosis.

ISRCTN	ISRCTN73885145
DOI	https://doi.org/10.1186/ISRCTN73885145
Secondary identifying numbers	GMQQ010401

Submission date: 08/07/2004
Registration date: 09/08/2004
Last edited: 19/08/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Nervous System Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Christoph Heesen
Scientific

University Hospital Eppendorf
Department of Neurology
Martinistrasse 52
Hamburg
D-20246
Germany

Phone	+49 (0)40428032794
Email	heesen@uke.uni-hamburg.de

Study information

Study design	Multicentre randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Other
Scientific title
Study acronym	EBSIMS
Study objectives	Not provided at time of registration
Ethics approval(s)	Not provided at time of registration
Health condition(s) or problem(s) studied	Relapsing-remitting Multiple Sclerosis (MS)
Intervention	Intervention group: Participants in the intervention group are provided with a brochure, critically appraising the evidence on relapses and relapse management, considering aspects of evidence-based medicine and evidence-based patient information. Participants take part in a 5-hour nurse-led training session and are subsequently given the opportunity to receive a prescription for methylpredisolone tablets (25 x 100 mg) allowing them to take 500 mg for 5 days in case of a relapse. If the medication has been used a new subscription can be obtained. Participants in the intervention group may still decide to receive intravenous treatment at their neurologist's office or a hospital. Control group: Participants in the control group are given a leaflet informing them about relapse treatment, including the possibility of oral steroid therapy.
Intervention type	Other
Primary outcome measure	Percentage of relapses without steroid-treatment or with oral steroid-treatment within 2 years of follow-up.
Secondary outcome measures	1. Time to initiation of treatment 2. Overall costs 3. Characteristics of steroid-treatments 4. Changes in autonomy preferences 5. Protection motivation 6. Quality of life 7. Relapse severity 8. Adverse treatment effects 9. Other clinical variables
Overall study start date	01/04/2003
Completion date	30/04/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	Added 19/08/09 ;
Key inclusion criteria	Patients with relapsing-remitting Multiple Sclerosis (MS), with at least 2 relapses in the last 24 months or at least one relapse in the last 12 months.
Key exclusion criteria	Patients with severe cognitive deficits or pregnancy
Date of first enrolment	01/04/2003
Date of final enrolment	30/04/2005

Locations

Countries of recruitment

Germany

Study participating centre

University Hospital Eppendorf

Hamburg
D-20246
Germany

Sponsor information

University of Hamburg (Germany)
University/education

Department of Neurology/Unit of Health Sciences and Education
Martinistrasse 52
Hamburg
D-20246
Germany

Phone	+49 (0)40428032794
Email	heesen@uke.uni-hamburg.de
"ROR"	https://ror.org/04bs1pb34

Funders

Funder type

Government

German Ministry of Health (Germany)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/01/2009		Yes	No