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

Multiple Sclerosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01195857
• Other study ID #: EMR701068-512
• Status: Completed
• Phase: N/A
• First received: August 31, 2010
• Last updated: February 3, 2014
• Start date: January 2009
• Est. completion date: September 2009

Study information

• Verified date: February 2014
• Source: Merck KGaA
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Multiple Sclerosis

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Merck KGaA	Merck Serono Limited, UK

References & Publications (1)

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Most common 3 steps for error with the Rebiject II injection device out of the ten step checklist		up to 6 month	No
Secondary	Correlation with recent training within the last 6 months		up to 6 month	No
Secondary	Correlation with disease control (relapse rate)		up to 6 month	No
Secondary	Length of time on treatment		up to 6 month	No
Secondary	Presence of injection site reactions		up to 6 month	Yes
Secondary	Cognitive impairment		up to 6 month	No