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
Scientific
Institute of Neuroimmunology and Clinical MS Research (INIMS)
Martinistr. 52
Hamburg
20246
Germany
| heesen@uke.uni-hamburg.de |
Study information
| Study design | Multicentre controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 | 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 study start date | 01/04/2010 |
| Completion date | 30/09/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
20246
Germany
Sponsor information
Association for the Advancement of Rehabilitation Research in Schleswig-Holstein (VFFR) (Germany)
Research organisation
Research organisation
Ziegelstr. 150
Lübeck
D-23556
Germany
| nathalie.glaser-moeller@drv-nord.de | |
| Website | http://www.reha-vffr.de/ |
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)
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., 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 share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
Editorial Notes
13/04/2016: Publication reference added.
