Patient Education Programme for Multiple Sclerosis (MS) Immunotherapy

ISRCTN	ISRCTN83438362
DOI	https://doi.org/10.1186/ISRCTN83438362
Protocol serial number	1
Sponsor	Association for the Advancement of Rehabilitation Research in Schleswig-Holstein (VFFR) (Germany)
Funders	Association for the Advancement of Rehabilitation Research in Schleswig-Holstein (Verein zur Förderung der Rehabilitationsforschung in Schleswig-Holstein e.V. [VFFR]) (Germany), National Multiple Sclerosis Society

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

Email	heesen@uke.uni-hamburg.de

Study information

Primary study design	Interventional
Study design	Multicentre controlled trial
Secondary study design	Non randomised study
Study type	Participant information sheet
Scientific title	Effectiveness of a patient education programme on immunotherapy in multiple sclerosis - a multicentre controlled trial
Study acronym	PEPIMS
Study objectives	The 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) studied	Multiple sclerosis
Intervention	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-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 type	Other
Primary outcome measure(s)	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
Key secondary outcome measure(s)	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
Completion date	30/09/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	150
Key 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
Key exclusion criteria	1. Major cognitive deficit 2. Inability to independently fill in questionnaires, e.g., due to ataxia
Date of first enrolment	01/04/2010
Date of final enrolment	30/09/2011

Locations

Countries of recruitment

Germany

Study participating centre

Institute of Neuroimmunology and Clinical MS Research (INIMS)

Hamburg
20246
Germany

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not 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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes

Editorial Notes

13/04/2016: Publication reference added.