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

Completed

• Conditions: Multiple Sclerosis

• Registration Number: NCT01195857
• Lead Sponsor: Merck KGaA, Darmstadt, Germany

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-01
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Study First Submitted: 2010-08-31
• Study First Submitted QC: 2010-09-03
• Study First Posted: 2010-09-06
• Status Verified: 2014-02
• Last Update Submitted: 2014-02-03
• Last Update Posted: 2014-02-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of subjects who correctly use the Rebiject II injection device based on reaching all correct injection steps as assessed by a nurse	up to 6 month

Secondary Outcome Measures

Name	Time	Method
Correlation with disease control (relapse rate)	up to 6 month
Most common 3 steps for error with the Rebiject II injection device out of the ten step checklist	up to 6 month
Length of time on treatment	up to 6 month
Cognitive impairment	up to 6 month
Correlation with recent training within the last 6 months	up to 6 month
Presence of injection site reactions	up to 6 month