Clinical trial NCT00787657: Observational Study to Analyse the Impact of Nurse Support and Disease Related Factors on Long- Term Adherence to Betaferon Treatment
Official title: Betaferon Prospective Study on Adherence, Coping and Nursing Support
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Relapsing Remitting Multiple Sclerosis (RRMS)
Keywords: Clinically Isolated Syndrome (CIS)
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2008-11-07
Enrollment: 1723
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility 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)

Primary outcomes:
measure: Proportion of patients adhering to treatment
timeFrame: 6, 12, 18 and 24 months
Secondary outcomes:
measure: Rate of early treatment termination
timeFrame: 6, 12, 18 and 24 months
measure: Rate of study dropout
timeFrame: 6, 12, 18 and 24 months
measure: Predictive value of BL parameters, WCQ, HADS, RODQ
timeFrame: 12 and 24 months
measure: WCQ (Ways of Coping Questionnaire)
timeFrame: 6, 12, 18 and 24 months
measure: HADS (Hospital Anxiety and Depression Scale)
timeFrame: 6, 12, 18 and 24 months
measure: RODQ (Risk of Dropout Questionnaire)
timeFrame: Monthly over 6 months; every other month thereafter
measure: EDSS (Expanded Disability Status Scale)
timeFrame: 6, 12, 18 and 24 months
measure: Relapse rate
timeFrame: 6, 12, 18 and 24 months
Other outcomes:
Locations:
city: Many Locations
country: Argentina
city: Many Locations
country: Bahrain
city: Many Locations
country: Belgium
city: Many Locations
country: Bosnia and Herzegovina
city: Many Locations
country: Canada
city: Many Locations
country: China
city: Many Locations
country: Colombia
city: Many Locations
country: Czech Republic
city: Many Locations
country: Egypt
city: Many Locations
country: Estonia
city: Many Locations
country: France
city: Many Locations
country: Germany
city: Many Locations
country: Iran, Islamic Republic of
city: Many Locations
country: Israel
city: Many Locations
country: Italy
city: Many Locations
country: Jordan
city: Many Locations
country: Korea, Republic of
city: Many Locations
country: Kuwait
city: Many Locations
country: Lebanon
city: Many Locations
country: Libyan Arab Jamahiriya
city: Many Locations
country: Mexico
city: Many Locations
country: Netherlands
city: Many Locations
country: New Zealand
city: Many Locations
country: Norway
city: Many Locations
country: Pakistan
city: Many Locations
country: Portugal
city: Many Locations
country: Saudi Arabia
city: Many Locations
country: Singapore
city: Many Locations
country: Slovakia
city: Many Locations
country: Slovenia
city: Many Locations
country: Sweden
city: Many Locations
country: Syrian Arab Republic
city: Many Locations
country: Taiwan
city: Many Locations
country: United Arab Emirates
city: Many Locations
country: United Kingdom
city: Many Locations
country: Venezuela
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Patti F, Penaherrera JN, Zieger L, Wicklein EM. Clinical characteristics of middle-aged and older patients with MS treated with interferon beta-1b: post-hoc analysis of a 2-year, prospective, international, observational study. BMC Neurol. 2021 Aug 23;21(1):324. doi: 10.1186/s12883-021-02347-w.