Condition category
Nervous System Diseases
Date applied
08/07/2004
Date assigned
09/08/2004
Last edited
10/04/2012
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

GMQQ01019401

Study information

Scientific title

Acronym

ISDIMS

Study hypothesis

Not provided at time of registration

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

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

Phase

Not Specified

Drug names

Primary outcome measures

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).

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/2004

Overall trial end date

31/12/2005

Reason abandoned

Eligibility

Participant 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).

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Patients with a major cognitive deficit and/or who do not agree to data check at health insurance companies are excluded.

Recruitment start date

01/01/2004

Recruitment end date

31/12/2005

Locations

Countries of recruitment

Germany

Trial participating centre

University Hospital Eppendorf
Hamburg
D-20246
Germany

Sponsor information

Organisation

University of Hamburg

Sponsor details

University Hospital Eppendorf -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

Not defined

Website

Funders

Funder type

Government

Funder name

German Ministry of Health

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

1. 2011 validation study in http://www.ncbi.nlm.nih.gov/pubmed/22043310

Publication citations

  1. Validation study

    Kasper J, Heesen C, Köpke S, Fulcher G, Geiger F, Patients' and observers' perceptions of involvement differ. Validation study on inter-relating measures for shared decision making., PLoS ONE, 2011, 6, 10, e26255, doi: 10.1371/journal.pone.0026255.

Additional files

Editorial Notes