Assessment of Patient Use of a New Device: RebiSmart
Multiple sclerosis (MS) is a chronic disease which causes inflammation and destruction of the nerves in within the brain and the spinal cord. This disease is one of the most common causes of disability in young adults. A ''relapse'' is a phenomenon that occurs when there is an acute attack of disability as a result of an acute attack on the nervous system. There is usually some degree of recovery after a relapse.
Rebif is licensed in the United Kingdom for the treatment of relapsing MS and is given 3 times a week by injections under the skin. The RebiSmart device is a new injection device which has been developed to help patients with injecting their Rebif treatment.
Currently, all treatments for MS are injectable and require long term patient commitment. Patient compliance to treatment is important for the therapy to work effectively and decrease the risk of relapse episodes. Using a device that makes it easy for patients to inject may potentially improve compliance to treatment and therefore potentially have an impact on the number of relapses patients experience. The RebiSmart device has been developed for patients to inject conveniently and in comfort. The device allows the patient to control certain parameters such as needle depth, needle speed, injection time etc, and also has extra features designed to ease the injection process, such as a dose history calendar and an on−screen injection guide. The aim of this study is to determine what percentage of patients liked using the RebiSmart device and found it ''easy'' or ''very easy'' to use. The study will also determine which of the device features were most useful to the patients.
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Assessment of Patient Use of a New Device: RebiSmart|
- Percentage of subjects who liked using the RebiSmart device based on a score of 6 or more on a Visual Analogue Scale (VAS) at the end of 12-week treatment period [ Time Frame: up to week 16 ] [ Designated as safety issue: No ]
- Percentage of patients who found RebiSmart easy or very easy to use at the end of 12-week treatment period [ Time Frame: up to week 16 ] [ Designated as safety issue: No ]
- Top three functions of the device patients found most useful; top ranked from 1 to 10 [ Time Frame: up to week 16 ] [ Designated as safety issue: No ]
|Study Start Date:||July 2009|
|Study Completion Date:||October 2010|
|Primary Completion Date:||September 2010 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01195870
|Study Director:||Dr Gillian L Shepherd, MD, MRCP||Merck Serono Limited, UK|