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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.

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.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN25267500
Enrollment
Unknown
Registered
2004-08-09
Start date
2004-01-01
Completion date
Unknown
Last updated
2022-11-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple sclerosis (MS) Nervous System Diseases Multiple sclerosis (MS)

Interventions

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 patie

Sponsors

University of Hamburg
Lead Sponsor

Eligibility

Inclusion criteria

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).

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Not provided at time of registration

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 28, 2026