Condition category
Nervous System Diseases
Date applied
27/03/2010
Date assigned
14/04/2010
Last edited
13/04/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

http://www.reha-vffr.de/

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

Publication citations

Additional files

Editorial Notes

13/04/2016: Publication reference added.