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Completed

NCT Number: NCT00787657

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

* 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.

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Key information

Conditions

Relapsing Remitting Multiple Sclerosis (RRMS) Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting Nervous System Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Many Locations, Argentina

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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

Drug

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

Primary outcomes

  1. Proportion of patients adhering to treatment

    Time frame: 6, 12, 18 and 24 months

Secondary outcomes

  1. Rate of early treatment termination

    Time frame: 6, 12, 18 and 24 months

  2. Rate of study dropout

    Time frame: 6, 12, 18 and 24 months

  3. Predictive value of BL parameters, WCQ, HADS, RODQ

    Time frame: 12 and 24 months

  4. WCQ (Ways of Coping Questionnaire)

    Time frame: 6, 12, 18 and 24 months

  5. HADS (Hospital Anxiety and Depression Scale)

    Time frame: 6, 12, 18 and 24 months

  6. RODQ (Risk of Dropout Questionnaire)

    Time frame: Monthly over 6 months; every other month thereafter

  7. EDSS (Expanded Disability Status Scale)

    Time frame: 6, 12, 18 and 24 months

  8. Relapse rate

    Time frame: 6, 12, 18 and 24 months

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

Betaferon Prospective Study on Adherence, Coping and Nursing Support

Acronym: BEACON

Important dates

Study start
2008
Primary completion
2013
Study completion
2014
First posted
Nov 7, 2008
Registry last updated
Oct 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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