Relapsing-Remitting Multiple Sclerosis
Conditions
Keywords
Multiple Sclerosis, Interferon beta-1b
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.
Interventions
Interferon beta-1b (Betaferon) and Personal Digital Assistant together with a reminder
Sponsors
Bayer
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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. *
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Drop out rate over 2 years | 24 months |
Secondary
| Measure | Time frame |
|---|---|
| Grade of depressiveness | After 3, 6, 12 and 24 months |
| Grade of fatigue | After 3, 6, 12 and 24 months |
| Disability status | After 3, 6, 12 and 24 months |
| Cognitive status | After 12 and 24 months |
| Injection regularity | After 3, 6, 12 and 24 months |
| Quality of life | After 3, 6, 12 and 24 months |
Countries
Germany
Outcome results
None listed