Assessment of Patient Use of a New Device: RebiSmart

This study has been completed.
Sponsor:
Collaborator:
Merck Serono Limited, UK
Information provided by (Responsible Party):
Merck KGaA
ClinicalTrials.gov Identifier:
NCT01195870
First received: August 31, 2010
Last updated: February 14, 2014
Last verified: February 2014

August 31, 2010
February 14, 2014
July 2009
September 2010   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01195870 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Assessment of Patient Use of a New Device: RebiSmart
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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

Patients, who are under regular review by a Multiple Sclerosis nurse, with relapsing remitting multiple sclerosis who have been prescribed Rebif and have chosen to use the RebiSmart device for drug administration.

Multiple Sclerosis
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D'Arcy C, Thomas D, Stoneman D, Parkes L. Patient assessment of an electronic device for subcutaneous self-injection of interferon β-1a for multiple sclerosis: an observational study in the UK and Ireland. Patient Prefer Adherence. 2012;6:55-61. doi: 10.2147/PPA.S26250. Epub 2012 Jan 18.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
63
October 2010
September 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Have relapsing remitting multiple sclerosis
  • Between 18 to 65 years old inclusive
  • Have been prescribed Rebif for the first time but not yet started treatment
  • Rebismart as chosen device
  • Be under review by MS nurse
  • Having given written informed consent to participate in the study

Exclusion Criteria:

  • Injections of Rebif given by someone other than the patient
  • Patients unable to use the Rebismart device due to visual or physical impairment
  • Patients unwilling to give informed consent
  • Contra-indications to Rebif as defined in the Summary of Product Characteristics (SPC).
  • Allergy to the antipyretic analgesics that will be advised as prophylaxis for flu-like symptoms
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01195870
EMR701068-514
No
Merck KGaA
Merck KGaA
Merck Serono Limited, UK
Study Director: Dr Gillian L Shepherd, MD, MRCP Merck Serono Limited, UK
Merck KGaA
February 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP