Assessment of Subject Use of the Rebiject II Injection Device According to Nurse Examination of Subject Accuracy in 10 Steps as a Dummy Demonstration

NCT ID: NCT01195857

Last Updated: 2014-02-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-01-31
• Study Completion Date: 2009-09-30

Brief Summary

Multiple sclerosis (MS) is a chronic, inflammatory, demyelinating disease of the central nervous system (CNS) and is one of the most common causes of neurological disability in young adults. Rebif is licensed in the United Kingdom for the treatment of relapsing MS and is given 3 times per week by subcutaneous injection. The Rebiject II device is an autoinjector which allows patients easier administration of their Rebif injections.

Prior to treatment, patients receive training on the use of the device and its maintenance. Currently, all treatments for MS are injectable and require long term patient commitment. Rebiject has been developed to improve patient convenience and comfort but does require multiple steps to be carried out in order for the injection to be delivered correctly. Reports from our local call centre and nurse advisors suggest that inaccuracies of use with the Rebiject device are common. By raising awareness of the level of inaccuracy and determining which steps patients are most likely not to complete correctly, modified training programs or modifications to current subject training may be put into place to address these issues. It is also important to demonstrate the link between poor use of the medication device and increased relapse rates or increased injection site reactions.

Conditions

Multiple Sclerosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Have relapsing remitting multiple sclerosis and currently receiving Rebif treatment and using the Rebiject II injection device
• Be under regular review by a MS nurse
• Be aged 18 or above
• Be willing and able to participate in the trial and to have provided written informed consent

Exclusion Criteria

• Receiving disease modifying therapy other than Rebif
• Receiving Rebif but not using the Rebiject II injection device
• Do not self inject
• Are unable or unwilling to provide informed consent

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Serono Limited, UK

INDUSTRY

Sponsor Role: collaborator

Merck KGaA, Darmstadt, Germany

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dr Gillian L Shepherd, MD, MRCP

Role: STUDY_DIRECTOR

Merck Serono Limited, UK

References

Caroline D'Arcy, Laura Parkes, Gillian Shepherd British Journal of Neuroscience Nursing, Vol. 8, Iss. 1, 26 Feb 2012, pp 25 - 31

Reference Type: RESULT

Other Identifiers

EMR701068-512

Identifier Type: -

Identifier Source: org_study_id