Clinical trial NCT01195857: Assessment of Subject Use of the Rebiject II Injection Device According to Nurse Examination of Subject Accuracy in 10 Steps as a Dummy Demonstration
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Multiple Sclerosis
Keywords: Multiple sclerosis
Rebif
Interferon beta-1a
Lead sponsor: Merck KGaA, Darmstadt, Germany
Sponsor class: INDUSTRY
Collaborators: name: Merck Serono Limited, UK
First posted: 2010-09-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with relapsing remitting multiple sclerosis who are currently receiving Rebif treatment and using the Rebiject II injection device who are under regular review by a Multiple Sclerosis nurse.

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.


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

Primary outcomes:
measure: Percentage of subjects who correctly use the Rebiject II injection device based on reaching all correct injection steps as assessed by a nurse
timeFrame: up to 6 month
Secondary outcomes:
measure: Most common 3 steps for error with the Rebiject II injection device out of the ten step checklist
timeFrame: up to 6 month
measure: Correlation with recent training within the last 6 months
timeFrame: up to 6 month
measure: Correlation with disease control (relapse rate)
timeFrame: up to 6 month
measure: Length of time on treatment
timeFrame: up to 6 month
measure: Presence of injection site reactions
timeFrame: up to 6 month
measure: Cognitive impairment
timeFrame: up to 6 month
Other outcomes:
Locations:
Study officials:
affiliation: Merck Serono Limited, UK
name: Dr Gillian L Shepherd, MD, MRCP
role: STUDY_DIRECTOR
References:
citation: Caroline D'Arcy, Laura Parkes, Gillian Shepherd British Journal of Neuroscience Nursing, Vol. 8, Iss. 1, 26 Feb 2012, pp 25 - 31