Condition category
Nervous System Diseases
Date applied
08/07/2004
Date assigned
09/08/2004
Last edited
19/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Christoph Heesen

ORCID ID

Contact details

University Hospital Eppendorf
Department of Neurology
Martinistrasse 52
Hamburg
D-20246
Germany
+49 (0)40428032794
heesen@uke.uni-hamburg.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

GMQQ010401

Study information

Scientific title

Acronym

EBSIMS

Study hypothesis

Not provided at time of registration

Ethics approval

Not provided at time of registration

Study design

Multicentre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Other

Patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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 trial start date

01/04/2003

Overall trial end date

30/04/2005

Reason abandoned

Eligibility

Participant 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.

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Added 19/08/09
;

Participant exclusion criteria

Patients with severe cognitive deficits or pregnancy

Recruitment start date

01/04/2003

Recruitment end date

30/04/2005

Locations

Countries of recruitment

Germany

Trial participating centre

University Hospital Eppendorf
Hamburg
D-20246
Germany

Sponsor information

Organisation

University of Hamburg (Germany)

Sponsor details

Department of Neurology/Unit of Health Sciences and Education
Martinistrasse 52
Hamburg
D-20246
Germany
+49 (0)40428032794
heesen@uke.uni-hamburg.de

Sponsor type

University/education

Website

Funders

Funder type

Government

Funder name

German Ministry of Health (Germany)

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

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/18845657

Publication citations

  1. Results

    Köpke S, Kasper J, Mühlhauser I, Nübling M, Heesen C, Patient education program to enhance decision autonomy in multiple sclerosis relapse management: a randomized-controlled trial., Mult. Scler., 2009, 15, 1, 96-104, doi: 10.1177/1352458508095921.

Additional files

Editorial Notes