Contact information
Type
Scientific
Primary contact
Prof Christoph Heesen
ORCID ID
Contact details
Institute of Neuroimmunology and Clinical MS Research (INIMS)
Martinistr. 52
Hamburg
20246
Germany
-
heesen@uke.uni-hamburg.de
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
1
Study information
Scientific title
Effectiveness of a patient education programme on immunotherapy in multiple sclerosis - a multicentre controlled trial
Acronym
PEPIMS
Study hypothesis
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
Ethics Committee of the Hamburg Chamber of Physicians, 03/12/2009, ref: PV3385
Study design
Multicentre controlled trial
Primary study design
Interventional
Secondary study design
Non randomised study
Trial setting
Other
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Not Applicable
Drug names
Primary outcome measures
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 outcome measures
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
Overall trial start date
01/04/2010
Overall trial end date
30/09/2011
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
150
Participant exclusion criteria
1. Major cognitive deficit
2. Inability to independently fill in questionnaires, e.g., due to ataxia
Recruitment start date
01/04/2010
Recruitment end date
30/09/2011
Locations
Countries of recruitment
Germany
Trial participating centre
Institute of Neuroimmunology and Clinical MS Research (INIMS)
Hamburg
20246
Germany
Sponsor information
Organisation
Association for the Advancement of Rehabilitation Research in Schleswig-Holstein (VFFR) (Germany)
Sponsor details
Ziegelstr. 150
Lübeck
D-23556
Germany
-
nathalie.glaser-moeller@drv-nord.de
Sponsor type
Research organisation
Website
Funders
Funder type
Research organisation
Funder name
Association for the Advancement of Rehabilitation Research in Schleswig-Holstein (Verein zur Förderung der Rehabilitationsforschung in Schleswig-Holstein e.V. [VFFR]) (Germany)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
National Multiple Sclerosis Society
Alternative name(s)
National MS Society
Funding Body Type
private sector organisation
Funding Body Subtype
foundation
Location
United States of America
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2016 results in: http://cre.sagepub.com/content/early/2016/04/07/0269215516639734.abstract