Informed Shared Decision making In Multiple Sclerosis immunotherapy (ISDIMS). A randomised controlled trial to investigate the effects of an evidence-based decision aid on decision-making about immunotherapy in multiple sclerosis.
| ISRCTN | ISRCTN25267500 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN25267500 |
| Protocol serial number | GMQQ01019401 |
| Sponsor | University of Hamburg |
| Funder | German Ministry of Health |
- Submission date
- 08/07/2004
- Registration date
- 09/08/2004
- Last edited
- 27/10/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Nervous System Diseases
Plain English summary of protocol
Not provided at time of registration
Contact information
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 | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant information sheet |
| Scientific title | Informed Shared Decision making In Multiple Sclerosis immunotherapy (ISDIMS). A randomised controlled trial to investigate the effects of an evidence-based decision aid on decision-making about immunotherapy in multiple sclerosis. |
| Study acronym | ISDIMS |
| Study objectives | Not provided at time of registration |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Multiple sclerosis (MS) |
| Intervention | Patients will be recruited nationwide through newspapers, self-help-group publications and the internet. Patients within a decision process about immunotherapy will be included. Those are either patients on therapy willing to re-evaluate their decision or patients about to make a therapeutic decision. A presupposition for this is an appointment with the treating neurologist in the near future. Intervention group: Participants in the intervention group are provided with a 'Decision Aid' including a comprehensive evidence based MS patient information about options of immunotherapy and an interactive working sheet to be dealt with before the appointment with the neurologist. Control group: Participants in the control group receive a set of standard information made available and recommended by the German MS-society. |
| Intervention type | Other |
| Primary outcome measure(s) |
Primary endpoint are the 'realized role preferences' defined as the difference between autonomy preferences (pre intervention) and performed autonomy (post appointment). A difference as small as possible is defined as the desirable outcome. Secondary endpoints include the number of continued, changed, interrupted, or newly started immunotherapies. Also, analyses of the 'shared decision process' and 'decision evaluation' are performed. We also look at a number of control parameters (eg. other information sources, time to initiation of treatment, control beliefs, etc.) and clinical variables (disability status and disease activity). |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/12/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Total final enrolment | 297 |
| Key inclusion criteria | Patients with multiple sclerosis who consider a new immunotherapy or who are willing to reconsider a decision (no selection of certain disease courses). |
| Key exclusion criteria | Patients with a major cognitive deficit and/or who do not agree to data check at health insurance companies are excluded. |
| Date of first enrolment | 01/01/2004 |
| Date of final enrolment | 31/12/2005 |
Locations
Countries of recruitment
- Germany
Study participating centre
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 | Not provided at time of registration |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 01/12/2008 | 27/10/2022 | Yes | No | |
| Other publications | validation study | 01/01/2011 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
27/10/2022: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
07/01/2021: Internal review.
