Patient education programme for early multiple sclerosis (MS)

Effectiveness of a patient education program about diagnosis, prognosis and early treatment in multiple sclerosis: a randomised controlled trial

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN12440282

Enrollment

190

Registered

2009-05-14

Start date

2009-04-15

Completion date

Unknown

Last updated

2015-01-13

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

Interventions

Experimental intervention: Patient education programme based on the principles of evidence-based patient information comprising an educational booklet on MS diagnosis, prognosis and early therapy and

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Possible or definite relapsing form of MS following revised McDonald criteria 2. Diagnosis within the last 12 months 3. Aged 18 - 60 years, either sex

Exclusion criteria

Exclusion criteria: 1. Major cognitive deficit 2. Progressive form of MS

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. Control beliefs, assessed 2 weeks before the intervention and at the end of follow-up using the German questionnaire on control beliefs in illness (KKG) 2. Decision autonomy, assessed 2 weeks before the intervention and at the end of follow-up using the using a previously used scale based on the Control Preference Scale 3. Decision conflict and satisfaction with the decision will be assessed 2 weeks before the intervention and at the end of follow-up using the Decisional Conflict Scale (DCS) 4. Anxiety and depression, assessed after randomisation, three months after the intervention, and at the end of follow-up using the Hospital Anxiety and Depression Scale (HADS) 5. Number of newly initiated and discontinued immunotherapies (participants on immunotherapy 12 months after the intervention), assessed by telephone interview at randomisation and 3, 6, 9, and 12 months after the intervention using a standardised protocol used in an earlier trial 6. Disease related resource use (costs) will be assessed by telephone interview at randomisation and 3, 6, 9, and 12 months after the intervention using a standardised protocol that has been succesfully used in an earlier trials Assessment of safety: 7. Disease progression, measured with a validated German version of the UNDS at randomisation and the end of follow-up. The instrument has been succesfully used in an earlier trial. 8. Health-related quality of life, assessed 2 weeks before the intervention and at the end of follow-up using the HAQUAMS instrument	—

Measure

Time frame

1. Control beliefs, assessed 2 weeks before the intervention and at the end of follow-up using the German questionnaire on control beliefs in illness (KKG) 2. Decision autonomy, assessed 2 weeks before the intervention and at the end of follow-up using the using a previously used scale based on the Control Preference Scale 3. Decision conflict and satisfaction with the decision will be assessed 2 weeks before the intervention and at the end of follow-up using the Decisional Conflict Scale (DCS) 4. Anxiety and depression, assessed after randomisation, three months after the intervention, and at the end of follow-up using the Hospital Anxiety and Depression Scale (HADS) 5. Number of newly initiated and discontinued immunotherapies (participants on immunotherapy 12 months after the intervention), assessed by telephone interview at randomisation and 3, 6, 9, and 12 months after the intervention using a standardised protocol used in an earlier trial 6. Disease related resource use (costs) will be assessed by telephone interview at randomisation and 3, 6, 9, and 12 months after the intervention using a standardised protocol that has been succesfully used in an earlier trials Assessment of safety: 7. Disease progression, measured with a validated German version of the UNDS at randomisation and the end of follow-up. The instrument has been succesfully used in an earlier trial. 8. Health-related quality of life, assessed 2 weeks before the intervention and at the end of follow-up using the HAQUAMS instrument

—

Countries

Germany

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026