An Observational, Retrospective, UK & Ireland Audit of Patient Adherence to Rebif® Injections Using the RebiSmart™ Injection Device

REbiSmart™ Retrospective ADherencE Review (READER) An Observational, Retrospective, UK & Ireland Audit of Patient Adherence to Rebif® Injections Using the RebiSmart™ Injection Device

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01601080

Acronym

READER

Enrollment

230

Registered

2012-05-17

Start date

2012-04-30

Completion date

Unknown

Last updated

2014-02-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Relapsing Multiple Sclerosis

Keywords

Adherence, Multiple Sclerosis

Brief summary

This is an observational, retrospective, UK & Ireland audit measuring patient adherence to Rebif® injections with the RebiSmart™ injection device. Data will be collected from Multiple Sclerosis (MS) patients who have been prescribed Rebif® and have been using the RebiSmart™ device for injection for a minimum of 24 months.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

16 Years to No maximum

Healthy volunteers

Inclusion criteria

* Relapsing Multiple Sclerosis (Relapsing Remitting Multiple Sclerosis and Secondary Progressive Multiple Sclerosis with relapses) according to the Association of British Neurologists criteria (30) in the UK and the revised 2005 McDonald criteria (31) in Ireland * Prescribed Rebif® (22mcg or 44mcg) using the RebiSmart™ injection device * Have been using RebiSmart™ for 24 months and be due a device replacement as part of their standard routine of care * Registered with Bupa Home Healthcare (UK) or SENSE nurse (Ireland) * Be willing to give consent for their adherence data to be captured in the audit

Exclusion criteria

Patients who do not fulfill entirely the inclusion criteria as well as the following: * Discontinued Rebif before 24 months of treatment * Unable or unwilling to give consent for their adherence data to be captured in the audit

Design outcomes

Primary

Measure	Time frame	Description
Patient Adherence	24 months	Percentage RebiSmart measured patient adherence to Rebif® injections

Secondary

Measure	Time frame	Description
Difference in patient adherence over time	12 months	Difference in percentage patient adherence between the first 12 months and second 12 months of treatment period.
Medication Possession Ratio	12 months	Difference of the patient MPR (as a percentage) versus the patient's RebiSmart™ recorded percentage adherence levels
Patient Adherence	1 month	Percentage RebiSmart measured patient adherence to Rebif® injections
Patient Adherence in the UK versus Ireland	12 months	Reporting of UK and Ireland actual adherence levels separately
Device Comfort Settings	12 months	Preferred final comfort settings (at last injection)
Adherence of patient subgroups	12 months	RebiSmart™ measured percentage adherence within and between the following patient sub-groups: * patients who are and are not registered to MySupport (Rebif Support Programme) * patient age groups * patient gender * prior use of a DMT

Countries

United Kingdom

Outcome results