Assessment of Patient Use of a New Device: RebiSmart

NCT ID: NCT01195870

Last Updated: 2014-02-17

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 63 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-07-31
• Study Completion Date: 2010-10-31

Brief Summary

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.

Conditions

Multiple Sclerosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Serono Limited, UK

INDUSTRY

Sponsor Role: collaborator

Merck KGaA, Darmstadt, Germany

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dr Gillian L Shepherd, MD, MRCP

Role: STUDY_DIRECTOR

Merck Serono Limited, UK

References

D'Arcy C, Thomas D, Stoneman D, Parkes L. Patient assessment of an electronic device for subcutaneous self-injection of interferon beta-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.

Reference Type: RESULT

PMID: 22298944 (View on PubMed)

Other Identifiers

EMR701068-514

Identifier Type: -

Identifier Source: org_study_id