Rebif Compliance Support Program - Assessing Needs in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

— AIMS  

Official title:

A Questionnaire Based Survey to Identify Issues With Patient Compliance and to Develop Solutions to Improve Rebif Compliance and Improve Patient Outcomes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01080573
• Other study ID #: MMFM 100
• Status: Completed
• Phase: N/A
• First received: March 3, 2010
• Last updated: July 30, 2014
• Start date: January 2007
• Est. completion date: April 2011

Study information

• Verified date: April 2011
• Source: Merck KGaA
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: National Health Service
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1257
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Locations

Country	Name	City	State
United Kingdom	Bupa Home Healthcare	Harlow	Essex

Sponsors (1)

Lead Sponsor	Collaborator
Merck KGaA

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Discontinuation of Rebif treatment (yes or no)		Data collection is expected to end 3 months after last subject is recruited	No