Condition category
Nervous System Diseases
Date applied
07/04/2009
Date assigned
14/05/2009
Last edited
07/03/2014
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)
Martinistrasse 52
Hamburg
20246
Germany
heesen@uke.uni-hamburg.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Inims3

Study information

Scientific title

Effectiveness of a patient education program about diagnosis, prognosis and early treatment in multiple sclerosis: a randomised controlled trial

Acronym

PEPADIP

Study hypothesis

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

Ethics Committee of the Hamburg Chamber of Physicians approved on the 12th March 2009 (ref: PV3164)

Study design

Multicentre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

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 (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

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. 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 trial start date

15/04/2009

Overall trial end date

15/04/2011

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

190

Participant exclusion criteria

1. Major cognitive deficit
2. Progressive form of MS

Recruitment start date

15/04/2009

Recruitment end date

15/04/2011

Locations

Countries of recruitment

Germany

Trial participating centre

Institute of Neuroimmunology and Clinical MS Research (INIMS)
Hamburg
20246
Germany

Sponsor information

Organisation

Merck Serono (Germany)

Sponsor details

Gutenbergstr. 5
Unterschleißheim
85716
Germany
norbert.zessack@merckserono.net

Sponsor type

Industry

Website

http://www.merckserono.com/en/index.html

Funders

Funder type

Industry

Funder name

Merck Serono (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

National MS Society (USA)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

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

2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/24104856

Publication citations

  1. Results

    Köpke S, Kern S, Ziemssen T, Berghoff M, Kleiter I, Marziniak M, Paul F, Vettorazzi E, Pöttgen J, Fischer K, Kasper J, Heesen C, Evidence-based patient information programme in early multiple sclerosis: a randomised controlled trial., J. Neurol. Neurosurg. Psychiatr., 2014, 85, 4, 411-418, doi: 10.1136/jnnp-2013-306441.

Additional files

Editorial Notes