Patient education programme for early multiple sclerosis (MS)
| ISRCTN | ISRCTN12440282 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12440282 |
| Secondary identifying numbers | Inims3 |
- Submission date
- 07/04/2009
- Registration date
- 14/05/2009
- Last edited
- 07/03/2014
- 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)
Martinistrasse 52
Hamburg
20246
Germany
| heesen@uke.uni-hamburg.de |
Study information
| Study design | Multicentre randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| 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 program about diagnosis, prognosis and early treatment in multiple sclerosis: a randomised controlled trial |
| Study acronym | PEPADIP |
| Study objectives | The study aims to assess the effects of an evidence-based patient education programme on multiple sclerosis (MS) diagnosis, prognosis and early treatment for patients in the first year of the disease. We hypothesise that the educational programme: 1. Increases relevant disease-related risk-knowledge and promotes informed choice 2. Promotes sense of control, decision autonomy and satisfaction 3. As a result leads to an altered, i.e., more rational approach to immunotherapies, and 4. Reduces anxiety and depression |
| Ethics approval(s) | Ethics Committee of the Hamburg Chamber of Physicians approved on the 12th March 2009 (ref: PV3164) |
| Health condition(s) or problem(s) studied | Multiple sclerosis (MS) |
| Intervention | Experimental intervention: Patient education programme based on the principles of evidence-based patient information comprising an educational booklet on MS diagnosis, prognosis and early therapy and a four-hour small group teaching programme. Control intervention: Four-hour small group stress management and coping training and standard information leaflet on diagnosis, prognosis and early therapy. Follow-up will be 12 months for both groups. |
| 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. Control beliefs, assessed 2 weeks before the intervention and at the end of follow-up using the German questionnaire on control beliefs in illness (KKG) 2. Decision autonomy, assessed 2 weeks before the intervention and at the end of follow-up using the using a previously used scale based on the Control Preference Scale 3. Decision conflict and satisfaction with the decision will be assessed 2 weeks before the intervention and at the end of follow-up using the Decisional Conflict Scale (DCS) 4. Anxiety and depression, assessed after randomisation, three months after the intervention, and at the end of follow-up using the Hospital Anxiety and Depression Scale (HADS) 5. Number of newly initiated and discontinued immunotherapies (participants on immunotherapy 12 months after the intervention), assessed by telephone interview at randomisation and 3, 6, 9, and 12 months after the intervention using a standardised protocol used in an earlier trial 6. Disease related resource use (costs) will be assessed by telephone interview at randomisation and 3, 6, 9, and 12 months after the intervention using a standardised protocol that has been succesfully used in an earlier trials Assessment of safety: 7. Disease progression, measured with a validated German version of the UNDS at randomisation and the end of follow-up. The instrument has been succesfully used in an earlier trial. 8. Health-related quality of life, assessed 2 weeks before the intervention and at the end of follow-up using the HAQUAMS instrument |
| Overall study start date | 15/04/2009 |
| Completion date | 15/04/2011 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 190 |
| Key inclusion criteria | 1. Possible or definite relapsing form of MS following revised McDonald criteria 2. Diagnosis within the last 12 months 3. Aged 18 - 60 years, either sex |
| Key exclusion criteria | 1. Major cognitive deficit 2. Progressive form of MS |
| Date of first enrolment | 15/04/2009 |
| Date of final enrolment | 15/04/2011 |
Locations
Countries of recruitment
- Germany
Study participating centre
Institute of Neuroimmunology and Clinical MS Research (INIMS)
Hamburg
20246
Germany
20246
Germany
Sponsor information
Merck Serono (Germany)
Industry
Industry
Gutenbergstr. 5
Unterschleißheim
85716
Germany
| norbert.zessack@merckserono.net | |
| Website | http://www.merckserono.com/en/index.html |
"ROR" |
https://ror.org/04b2dty93 |
Funders
Funder type
Industry
Merck Serono (Germany)
No information available
National MS Society (USA)
No information available
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 | 01/04/2014 | Yes | No |
