DrugLib.com — Drug Information Portal

Rx drug information, pharmaceutical research, clinical trials, news, and more



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

Page last updated: August 20, 2015

-- advertisement -- The American Red Cross
 
Home | About Us | Contact Us | Site usage policy | Privacy policy

All Rights reserved - Copyright DrugLib.com, 2006-2017