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 |
| Protocol serial number | GMQQ010401 |
| Sponsor | University of Hamburg (Germany) |
| Funder | German Ministry of Health (Germany) |
- 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
Scientific
University Hospital Eppendorf
Department of Neurology
Martinistrasse 52
Hamburg
D-20246
Germany
| Phone | +49 (0)40428032794 |
|---|---|
| heesen@uke.uni-hamburg.de |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Multicentre randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Percentage of relapses without steroid-treatment or with oral steroid-treatment within 2 years of follow-up. |
| Key secondary outcome measure(s) |
1. Time to initiation of treatment |
| Completion date | 30/04/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | All |
| 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
D-20246
Germany
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | 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 |
