Patient Education Programme for Multiple Sclerosis (MS) Immunotherapy

ISRCTN ISRCTN83438362
DOI https://doi.org/10.1186/ISRCTN83438362
Secondary identifying numbers 1
Submission date
27/03/2010
Registration date
14/04/2010
Last edited
13/04/2016
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

Prof Christoph Heesen
Scientific

Institute of Neuroimmunology and Clinical MS Research (INIMS)
Martinistr. 52
Hamburg
20246
Germany

heesen@uke.uni-hamburg.de

Study information

Study designMulticentre controlled trial
Primary study designInterventional
Secondary study designNon randomised study
Study setting(s)Other
Study typeTreatment
Participant information sheet Not available in web format, please use the contact details below to request a patient information sheet
Scientific titleEffectiveness of a patient education programme on immunotherapy in multiple sclerosis - a multicentre controlled trial
Study acronymPEPIMS
Study objectivesThe study aims to assess the effects of an inter-active evidence based patient education programme on disease modifying therapy (immunotherapy) in multiple sclerosis (MS). We hypothesise that the educational programme:
1. Increases relevant disease-related risk-knowledge and promotes informed choice
2. Increases decision autonomy and satisfaction
3. As a result leads to an altered, i.e., more rational approach to immunotherapies
4. Reduces anxiety and depression
Ethics approval(s)Ethics Committee of the Hamburg Chamber of Physicians, 03/12/2009, ref: PV3385
Health condition(s) or problem(s) studiedMultiple sclerosis
Intervention1. 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-hour small group educational programme.

2. Control intervention:
Standard information leaflet on MS immunotherapy alongside standard rehabilitation programme.

Both interventions will be provided during patients' stay in the rehabilitation clinic (duration: usually 3 to 4 weeks).
Intervention typeOther
Primary outcome measureInformed 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 outcome measures1. 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
Overall study start date01/04/2010
Completion date30/09/2011

Eligibility

Participant type(s)Patient
Age groupAdult
Lower age limit18 Years
SexAll
Target number of participants150
Key inclusion criteria1. 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
Key exclusion criteria1. Major cognitive deficit
2. Inability to independently fill in questionnaires, e.g., due to ataxia
Date of first enrolment01/04/2010
Date of final enrolment30/09/2011

Locations

Countries of recruitment

  • Germany

Study participating centre

Institute of Neuroimmunology and Clinical MS Research (INIMS)
Hamburg
20246
Germany

Sponsor information

Funders

Funder type

Research organisation

Association for the Advancement of Rehabilitation Research in Schleswig-Holstein (Verein zur Förderung der Rehabilitationsforschung in Schleswig-Holstein e.V. [VFFR]) (Germany)

No information available

National Multiple Sclerosis Society
Government organisation / Associations and societies (private and public)
Alternative name(s)
National MS Society, The National Multiple Sclerosis Society, The National MS Society, National Multiple Sclerosis Society, Inc., Association for Advancement of Research on Multiple Sclerosis, Sociedad Nacional de Esclerosis, Sociedad Nacional de Esclerosis Múltiple, NMSS
Location
United States of America

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 plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 12/04/2016 Yes No

Editorial Notes

13/04/2016: Publication reference added.

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