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

February 3, 2014 updated by: Merck KGaA, Darmstadt, Germany

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck KGaA, Darmstadt, Germany

Collaborators

Merck Serono Limited, UK

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (ACTUAL)

September 1, 2009

Study Completion (ACTUAL)

September 1, 2009

Study Registration Dates

First Submitted

August 31, 2010

First Submitted That Met QC Criteria

September 3, 2010

First Posted (ESTIMATE)

September 6, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

February 4, 2014

Last Update Submitted That Met QC Criteria

February 3, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EMR701068-512

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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