Trials / Completed
CompletedNCT00787657
Observational Study to Analyse the Impact of Nurse Support and Disease Related Factors on Long- Term Adherence to Betaferon Treatment
Betaferon Prospective Study on Adherence, Coping and Nursing Support
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,723 (actual)
- Sponsor
- Bayer · Industry
- Sex
- All
- Age
- 12 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Interferon beta-1b (Betaseron, BAY86-5046) | Patients after first clinical events suggestive of MS (according to SMPC) and patients with RRMS within the first two years of diagnosis |
Timeline
- Start date
- 2008-06-01
- Primary completion
- 2013-09-01
- Completion
- 2014-10-01
- First posted
- 2008-11-07
- Last updated
- 2015-10-16
Locations
36 sites across 36 countries: Argentina, Bahrain, Belgium, Bosnia and Herzegovina, Canada, China, Colombia, Czechia, Egypt, Estonia, France, Germany, Iran, Israel, Italy, Jordan, Kuwait, Lebanon, Libya, Mexico, Netherlands, New Zealand, Norway, Pakistan, Portugal, Saudi Arabia, Singapore, Slovakia, Slovenia, South Korea, Sweden, Syria, Taiwan, United Arab Emirates, United Kingdom, Venezuela
Source: ClinicalTrials.gov record NCT00787657. Inclusion in this directory is not an endorsement.