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

October 15, 2015 updated by: Bayer

Betaferon Prospective Study on Adherence, Coping and Nursing Support

  • 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

1723

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Arm 1
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of patients adhering to treatment
Time Frame: 6, 12, 18 and 24 months
6, 12, 18 and 24 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bayer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2008

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

November 6, 2008

First Submitted That Met QC Criteria

November 6, 2008

First Posted (Estimate)

November 7, 2008

Study Record Updates

Last Update Posted (Estimate)

October 16, 2015

Last Update Submitted That Met QC Criteria

October 15, 2015

Last Verified

October 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13852
  • 311941 (Other Identifier: company internal)
  • BF0703 (Other Identifier: company internal)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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