Patient education programme for early multiple sclerosis (MS)

ISRCTN	ISRCTN12440282
DOI	https://doi.org/10.1186/ISRCTN12440282
Protocol serial number	Inims3
Sponsor	Merck Serono (Germany)
Funders	Merck Serono (Germany), National MS Society (USA)

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

Institute of Neuroimmunology and Clinical MS Research (INIMS)
Martinistrasse 52
Hamburg
20246
Germany

Email	heesen@uke.uni-hamburg.de

Study information

Primary study design	Interventional
Study design	Multicentre randomised controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant 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(s)	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.
Key secondary outcome measure(s)	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
Completion date	15/04/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	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

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	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
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes