Rebif Compliance Support Program - Assessing Needs in Multiple Sclerosis
Information source: Merck KGaA
ClinicalTrials.gov processed this data on August 20, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Multiple Sclerosis
Phase: N/A
Status: Completed
Sponsored by: Merck KGaA Official(s) and/or principal investigator(s): Dr Gillian Shepherd, MD MRCP, Study Director, Affiliation: Merck Serono UK Ltd
Summary
This 1-arm, open-label, multicentric, observational study aims to collect subject centric
information in line with routine care. Subjects' expectations of therapy, side effect
management and lifestyle may influence adherence to therapy. This survey aims to determine
whether such factors and/or others affect the successful initiation and maintenance of Rebif
therapy.
The data collected during this study will include information on the subject's treatment
including expectations, experience, training and support. The results of the study will be
used to understand the impact on subjects' compliance and tailor training and support
services to subject's need. It will also be made available to other healthcare organisations
involved in the subjects treatment.
Clinical Details
Official title: A Questionnaire Based Survey to Identify Issues With Patient Compliance and to Develop Solutions to Improve Rebif Compliance and Improve Patient Outcomes
Study design: Observational Model: Cohort, Time Perspective: Prospective
Primary outcome: Discontinuation of Rebif treatment (yes or no)
Detailed description:
Multiple sclerosis (MS) is a chronic, inflammatory, demyelinating disease of the central
nervous system and is one of the most common causes of neurological disability in young
adults. It is characterised by multifocal, recurrent attacks of neurological symptoms and
signs with variable recovery. Eventually the majority of subjects develop a progressive
clinical course. It is important to carefully initiate and maintain subjects with MS on
therapy. Information will be gathered in a structured way which will enable easier
identification of any subgroups of subjects who may be at risk of poor compliance. These
risk groups could possibly include groups with particular attributes such as poor
information at the start of treatment, unrealistic expectations or a particular life style.
This study will be conducted during the contact with the subject necessary to deliver the
homecare service. Participants will be contacted by Bupa Home Healthcare Multiple Sclerosis
subject coordinators by telephone to conduct specific questionnaires during the 4 stages of
the subject's treatment i. e. pre-installation of treatment, post installation of treatment,
monthly pre delivery of drug and at a subject's end treatment.
OBJECTIVES
- To collect subject centric information in line with routine care including subject's
expectations of therapy, side effect management and lifestyle may influence adherence
to therapy
- To determine whether such factors and/or others affect the successful initiation and
maintenance of Rebif therapy
Eligibility
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Subjects who have been prescribed Rebif and referred to Bupa Home Healthcare service
by one of the participating referring centres
Exclusion Criteria:
- Subject unwilling to give informed consent
- Subjects visiting private clinics
Locations and Contacts
Bupa Home Healthcare, Harlow, Essex CM19 5GU, United Kingdom
Additional Information
Starting date: January 2007
Last updated: July 30, 2014
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