NCT00902135CompletedNot Applicable
Betaferon® Injection Management: Non-interventional Study on Personal Digital Assistant (PDA)Supported Effects on Adherence to a Long-term Injection Therapy (BETAPATH)
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Bayer
- Enrollment
- 702
- Primary Endpoint
- Drop out rate over 2 years
Study Overview
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Group 1
Intervention: Interferon beta-1b (Betaseron, BAY86-5046) (Drug)
Group 2
Intervention: Interferon beta-1b (Betaseron, BAY86-5046) (Drug)
Group 3
Intervention: Interferon beta-1b (Betaseron, BAY86-5046) (Drug)
Outcomes
Primary Outcomes
Drop out rate over 2 years
Time Frame: 24 months
Secondary Outcomes
- 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)
Investigators
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