Clinical trial NCT01080573: Rebif Compliance Support Program - Assessing Needs in Multiple Sclerosis
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: Multiple sclerosis
Rebif
Interferon beta-1a
Lead sponsor: Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
First posted: 2010-03-04
Enrollment: 1257
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Subjects who have been prescribed Rebif and referred to Bupa Home Healthcare service by one of the participating referring centres.

Brief 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.

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 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

Primary outcomes:
measure: Discontinuation of Rebif treatment (yes or no)
timeFrame: Data collection is expected to end 3 months after last subject is recruited
Secondary outcomes:
Other outcomes:
Locations:
city: Harlow
country: United Kingdom
facility: Bupa Home Healthcare
state: Essex
Study officials:
affiliation: Merck Serono UK Ltd
name: Dr Gillian Shepherd, MD MRCP
role: STUDY_DIRECTOR
References: