Patient Education Programme for Multiple Sclerosis (MS) Immunotherapy

Effectiveness of a patient education programme on immunotherapy in multiple sclerosis - a multicentre controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN83438362

Enrollment

150

Registered

2010-04-14

Start date

2010-04-01

Completion date

Unknown

Last updated

2016-10-17

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

Conditions

Multiple sclerosis Nervous System Diseases Multiple sclerosis

Interventions

1. Experimental intervention: Patient education programme based on the principles of evidence-based patient information comprising an educational booklet on MS immunotherapy and a two-part 2- and 4-h

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Possible or definite MS following revised McDonald criteria 2. Attending rehabilitation programme in participating rehab centres during study period 3. Aged 18 - 65 years, either sex

Exclusion criteria

Exclusion criteria: 1. Major cognitive deficit 2. Inability to independently fill in questionnaires, e.g., due to ataxia

Design outcomes

Primary

Measure	Time frame
Informed choice (IC) about initiation or continuation of immunotherapies after 6 months of follow-up using an adaptation of the Multidimensional Measure of Informed Choice (MMIC), comprising appropriate disease-related risk-knowledge and consistency between attitude and decision	—

Secondary

Measure	Time frame
1. Autonomy preference assessed in the first week of rehabilitation (before the intervention) and after 6 months using a previously used scale based on the Control Preference Scale (CPS) 2. Risk knowledge after 6 months 3. Decision conflict and satisfaction with the decision assessed after 6 months using the Decisional Conflict Scale (DCS) 4. Anxiety and depression assessed in the third or fourth weeks of rehabilitation (after the intervention) using the Hospital Anxiety and Depression Scale (HADS) 5. Number of newly initiated and discontinued immunotherapies (participants on immunotherapy after 6 months) assessed at baseline and by telephone interview after 3 and 6 months using a standardised protocol used in earlier trials 6. Disease related resource use (costs) assessed at baseline and by telephone interview after 3 and 6 months using a standardised protocol used in earlier trials 7. Self-efficacy assessed at baseline and after 6 months using the RIGBY scale 8. Fatigue assessed at baseline and after 6 months using the Würzburg Fatigue Inventory for Multiple Sclerosis (WEIMuS) Scale Assessment of safety: 9. Disease progression assessed at baseline and after 6 months with a validated German version of the United Kingdom Disability Scale (UNDS) instrument 10. Health-related quality of life assessed at baseline and after 6 months using the 36-item Short Form Health Survey (SF36) instrument	—

Measure

Time frame

1. Autonomy preference assessed in the first week of rehabilitation (before the intervention) and after 6 months using a previously used scale based on the Control Preference Scale (CPS) 2. Risk knowledge after 6 months 3. Decision conflict and satisfaction with the decision assessed after 6 months using the Decisional Conflict Scale (DCS) 4. Anxiety and depression assessed in the third or fourth weeks of rehabilitation (after the intervention) using the Hospital Anxiety and Depression Scale (HADS) 5. Number of newly initiated and discontinued immunotherapies (participants on immunotherapy after 6 months) assessed at baseline and by telephone interview after 3 and 6 months using a standardised protocol used in earlier trials 6. Disease related resource use (costs) assessed at baseline and by telephone interview after 3 and 6 months using a standardised protocol used in earlier trials 7. Self-efficacy assessed at baseline and after 6 months using the RIGBY scale 8. Fatigue assessed at baseline and after 6 months using the Würzburg Fatigue Inventory for Multiple Sclerosis (WEIMuS) Scale Assessment of safety: 9. Disease progression assessed at baseline and after 6 months with a validated German version of the United Kingdom Disability Scale (UNDS) instrument 10. Health-related quality of life assessed at baseline and after 6 months using the 36-item Short Form Health Survey (SF36) instrument

—

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Mar 17, 2026