Injection Management With Betaferon: Influence on Adherence, Patients Satisfaction and Health Related Outcomes (BETAPATH)
Completed
- Conditions
- Relapsing-Remitting Multiple Sclerosis
- Interventions
- Registration Number
- NCT00902135
- Lead Sponsor
- Bayer
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 702
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.
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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.
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Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Group 1 Interferon beta-1b (Betaseron, BAY86-5046) - Group 2 Interferon beta-1b (Betaseron, BAY86-5046) - Group 3 Interferon beta-1b (Betaseron, BAY86-5046) -
- Primary Outcome Measures
Name Time Method Drop out rate over 2 years 24 months
- Secondary Outcome Measures
Name Time Method Disability status After 3, 6, 12 and 24 months Grade of depressiveness After 3, 6, 12 and 24 months Grade of fatigue After 3, 6, 12 and 24 months Quality of life After 3, 6, 12 and 24 months Cognitive status After 12 and 24 months Injection regularity After 3, 6, 12 and 24 months