Observational Study to Analyse the Impact of Nurse Support and Disease Related Factors on Long- Term Adherence to Betaferon Treatment
Information source: Bayer
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Relapsing Remitting Multiple Sclerosis (RRMS)
Intervention: Interferon beta-1b (Betaseron, BAY86-5046) (Drug)
Phase: N/A
Status: Completed
Sponsored by: Bayer Official(s) and/or principal investigator(s): Bayer Study Director, Study Director, Affiliation: Bayer
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.
Clinical Details
Official title: Betaferon Prospective Study on Adherence, Coping and Nursing Support
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: Proportion of patients adhering to treatment
Secondary outcome: Rate of early treatment terminationRate of study dropout Predictive value of BL parameters, WCQ, HADS, RODQ WCQ (Ways of Coping Questionnaire) HADS (Hospital Anxiety and Depression Scale) RODQ (Risk of Dropout Questionnaire) EDSS (Expanded Disability Status Scale) Relapse rate
Eligibility
Minimum age: 12 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patients after first clinical event suggestive of multiple Sclerosis (MS) (according
to SmPC) and patients with Relapsing / Remitting Multiple Sclerosis (RRMS) within the
first two years of diagnosis.
Exclusion Criteria:
- Contra-indications as indicated in Betaferon summary of Products
Characteristics (SmPC)
Locations and Contacts
Many Locations, Argentina
Many Locations, Bahrain
Many Locations, Belgium
Many Locations, Bosnia and Herzegovina
Many Locations, Canada
Many Locations, China
Many Locations, Colombia
Many Locations, Czech Republic
Many Locations, Egypt
Many Locations, Estonia
Many Locations, France
Many Locations, Germany
Many Locations, Iran, Islamic Republic of
Many Locations, Israel
Many Locations, Italy
Many Locations, Jordan
Many Locations, Korea, Republic of
Many Locations, Kuwait
Many Locations, Lebanon
Many Locations, Libyan Arab Jamahiriya
Many Locations, Mexico
Many Locations, Netherlands
Many Locations, New Zealand
Many Locations, Norway
Many Locations, Pakistan
Many Locations, Portugal
Many Locations, Saudi Arabia
Many Locations, Singapore
Many Locations, Slovakia
Many Locations, Slovenia
Many Locations, Sweden
Many Locations, Syrian Arab Republic
Many Locations, Taiwan
Many Locations, United Arab Emirates
Many Locations, United Kingdom
Many Locations, Venezuela
Additional Information
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Starting date: June 2008
Last updated: October 10, 2014
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