MedTrace Logo

Observational Study to Analyse the Impact of Nurse Support and Disease Related Factors on Long- Term Adherence to Betaferon Treatment

NCT00787657 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 1723

Last updated 2015-10-16

No results posted yet for this study

Summary

* The Study analyses the influence of selected factors on adherence to Betaferon treatment in patients with early multiple sclerosis (MS). The Investigator will document the relevant medical data regarding multiple sclerosis at every hospital visit, the patient will fill in two questionnaires at every visit: one about coping with the disease and the other about anxiety and depression.
* The Study particularly looks at the role of the support of the patient given by the multiple sclerosis nurses.The nurse will provide additional standardised information at start of treatment and will regularly phone the patient to ask standardised questions about the general condition with regard to the treatment, the disease and social support. At the end of the Study it will be assessed if the supportive measures and the standards in terms of adherence management in the hospital have some influence to increase long-term treatment adherence.

Conditions

  • Relapsing Remitting Multiple Sclerosis (RRMS)

Interventions

DRUG

Interferon beta-1b (Betaseron, BAY86-5046)

Patients after first clinical events suggestive of MS (according to SMPC) and patients with RRMS within the first two years of diagnosis

Sponsors & Collaborators

Principal Investigators

  • Bayer Study Director · Bayer

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2013-09-30
Completion
2014-10-31

Countries

  • Argentina
  • Bahrain
  • Belgium
  • Bosnia and Herzegovina
  • Canada
  • China
  • Colombia
  • Czechia
  • Egypt
  • Estonia
  • France
  • Germany
  • Iran
  • Israel
  • Italy
  • Jordan
  • Kuwait
  • Lebanon
  • Libya
  • Mexico
  • Netherlands
  • New Zealand
  • Norway
  • Pakistan
  • Portugal
  • Saudi Arabia
  • Singapore
  • Slovakia
  • Slovenia
  • South Korea
  • Sweden
  • Syria
  • Taiwan
  • United Arab Emirates
  • United Kingdom
  • Venezuela

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00787657 on ClinicalTrials.gov