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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 termination

Rate 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

Page last updated: August 20, 2015

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