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

Completed

• Conditions: Relapsing Remitting Multiple Sclerosis (RRMS)
• Interventions: Drug: Interferon beta-1b (Betaseron, BAY86-5046)

• Registration Number: NCT00787657
• Lead Sponsor: Bayer

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-11-06
• Study First Submitted QC: 2008-11-06
• Study First Posted: 2008-11-07
• Primary Completion: 2013-09
• Study Completion: 2014-10
• Status Verified: 2015-10
• Last Update Submitted: 2015-10-15
• Last Update Posted: 2015-10-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1723

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.

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Exclusion Criteria

• Contra-indications as indicated in Betaferon summary of Products Characteristics (SmPC)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Arm 1	Interferon beta-1b (Betaseron, BAY86-5046)	-

Primary Outcome Measures

Name	Time	Method
Proportion of patients adhering to treatment	6, 12, 18 and 24 months

Secondary Outcome Measures

Name	Time	Method
HADS (Hospital Anxiety and Depression Scale)	6, 12, 18 and 24 months
Relapse rate	6, 12, 18 and 24 months
WCQ (Ways of Coping Questionnaire)	6, 12, 18 and 24 months
RODQ (Risk of Dropout Questionnaire)	Monthly over 6 months; every other month thereafter
Rate of study dropout	6, 12, 18 and 24 months
Rate of early treatment termination	6, 12, 18 and 24 months
Predictive value of BL parameters, WCQ, HADS, RODQ	12 and 24 months
EDSS (Expanded Disability Status Scale)	6, 12, 18 and 24 months