Clinical trial NCT00902135: Injection Management With Betaferon: Influence on Adherence, Patients Satisfaction and Health Related Outcomes (BETAPATH)
Official title: Betaferon® Injection Management: Non-interventional Study on Personal Digital Assistant (PDA)Supported Effects on Adherence to a Long-term Injection Therapy (BETAPATH)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Relapsing-Remitting Multiple Sclerosis
Keywords: Multiple Sclerosis
Interferon beta-1b
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2009-05-14
Enrollment: 702
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult female and male Clinically Isolated Syndrome (CIS) and relapsing-remitting multiple sclerosis (RRMS) patients who are at least 18 years of age, have started a treatment with Betaferon based on clinical decision by the treating neurologist and have completed the dose titration, will be documented after the therapy decision has been made.

The prescription of the medicine must be clearly independent from the decision to include the patient in the study.

Brief summary: Aim of the BETAPATH study is to evaluate whether the use of a personal digital assistant (PDA) can improve the adherence of Multiple Sclerosis patients to a therapy with Betaseron. The Personal digital assistant PDA functions as an electronic diary and as an injection reminder.


Eligibility criteria: Inclusion Criteria:

* Outpatients with the diagnosis of Multiple Sclerosis and decision by the investigator to prescribe Betaferon.The decision for treatment type and duration is taken before offering the patient the possibility to participate in the study.

Exclusion Criteria:

* Patients, who do not meet the Clinically Isolated Syndrome (CIS) or Relapsing/Remitting Multiple Sclerosis (RRMS) criteria, should not be included.
* Exclusion criteria must be read in conjunction with the German product information.

Primary outcomes:
measure: Drop out rate over 2 years
timeFrame: 24 months
Secondary outcomes:
measure: Disability status
timeFrame: After 3, 6, 12 and 24 months
measure: Grade of depressiveness
timeFrame: After 3, 6, 12 and 24 months
measure: Grade of fatigue
timeFrame: After 3, 6, 12 and 24 months
measure: Quality of life
timeFrame: After 3, 6, 12 and 24 months
measure: Cognitive status
timeFrame: After 12 and 24 months
measure: Injection regularity
timeFrame: After 3, 6, 12 and 24 months
Other outcomes:
Locations:
city: Many Locations
country: Germany
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: Zettl UK, Bauer-Steinhusen U, Glaser T, Hechenbichler K, Hecker M; Study Group. Comparative evaluation of patients' and physicians' satisfaction with interferon beta-1b therapy. BMC Neurol. 2016 Sep 21;16(1):181. doi: 10.1186/s12883-016-0705-1.
citation: Zettl UK, Bauer-Steinhusen U, Glaser T, Czekalla J, Hechenbichler K, Limmroth V, Hecker M. Adherence to Long-Term Interferon Beta-1b Injection Therapy in Patients with Multiple Sclerosis Using an Electronic Diary. Adv Ther. 2016 May;33(5):834-47. doi: 10.1007/s12325-016-0325-6. Epub 2016 Apr 18.
citation: Zettl UK, Bauer-Steinhusen U, Glaser T, Hechenbichler K, Limmroth V; Study Group. Evaluation of an electronic diary for improvement of adherence to interferon beta-1b in patients with multiple sclerosis: design and baseline results of an observational cohort study. BMC Neurol. 2013 Sep 6;13:117. doi: 10.1186/1471-2377-13-117.