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
Secondary identifying numbers GMQQ01019401
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
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 designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleInformed 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 acronymISDIMS
Study objectivesNot provided at time of registration
Ethics approval(s)Not provided at time of registration
Health condition(s) or problem(s) studiedMultiple sclerosis (MS)
InterventionPatients 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 typeOther
Primary outcome measurePrimary 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).
Secondary outcome measuresNot provided at time of registration
Overall study start date01/01/2004
Completion date31/12/2005

Eligibility

Participant type(s)Patient
Age groupNot Specified
SexNot Specified
Target number of participantsNot provided at time of registration
Total final enrolment297
Key inclusion criteriaPatients with multiple sclerosis who consider a new immunotherapy or who are willing to reconsider a decision (no selection of certain disease courses).
Key exclusion criteriaPatients with a major cognitive deficit and/or who do not agree to data check at health insurance companies are excluded.
Date of first enrolment01/01/2004
Date of final enrolment31/12/2005

Locations

Countries of recruitment

  • Germany

Study participating centre

University Hospital Eppendorf
Hamburg
D-20246
Germany

Sponsor information

University of Hamburg
Not defined

University Hospital Eppendorf -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 logo "ROR" https://ror.org/04bs1pb34

Funders

Funder type

Government

German Ministry of Health

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing planNot provided at time of registration

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Other publications validation study 01/01/2011 Yes No
Results article 01/12/2008 27/10/2022 Yes No

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.