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Open Access Research article

Evaluation of an electronic diary for improvement of adherence to interferon beta-1b in patients with multiple sclerosis: design and baseline results of an observational cohort study

Uwe K Zettl1*, Ulrike Bauer-Steinhusen2, Thomas Glaser2, Klaus Hechenbichler3, Volker Limmroth4 and for the Study Group

Author Affiliations

1 Klinik und Poliklinik für Neurologie, Universitätsmedizin Rostock, Rostock, Germany

2 Medizin Neurologie, Immunologie & Ophthalmologie, Bayer Vital GmbH, Leverkusen, Germany

3 Institute Dr. Schauerte, Oberhaching, Germany

4 Klinik für Neurologie, Städtisches Klinikum Köln-Merheim, Köln, Germany

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BMC Neurology 2013, 13:117  doi:10.1186/1471-2377-13-117

Published: 6 September 2013

Abstract

Background

Multiple sclerosis is a chronic, incurable, demyelinating disease that requires long-term treatment. Rates of non-adherence to prescribed therapy of up to 50% have been reported for chronic diseases. Strategies to improve treatment adherence are therefore of the utmost importance. This study will evaluate the effect of using electronic and paper diaries on treatment adherence to interferon beta-1b in patients with a first clinical isolated syndrome (CIS) or relapsing-remitting multiple sclerosis (RRMS). Here we report on the study design and results of baseline assessments.

Methods

Patients were recruited into a prospective national multicenter cohort study for an observational period of 2 years. At the start of the study, patients opted to use a digital (DiD) or paper diary (PD) to document self-administered injections of interferon beta-1b. Adherence to treatment will be assessed on the dropout rate at the end of the observation period and on the regularity of injections every other day at 6-month intervals. Patient-related health outcomes will also be evaluated.

Results

700 patients with a mean age of 38.3 (SD 10.3) years and a mean duration of disease since diagnosis of 3.6 (SD 5.9) years were enrolled. 383 patients opted for the digital diary, 192 of which included an injection reminder. Significantly more male than female patients opted for the DiD. Only gender was identified as a factor influencing the decision for DiD or PD. Based on rating scales, a significantly higher proportion of women had depressive comorbidities at baseline.

Conclusions

Demographic characteristics of the two cohorts were similar at baseline. More women chose a paper diary, and more had depression at baseline. These imbalances will be addressed in the analysis of the study as possible confounders influencing long-term treatment adherence in the digital and paper diary cohorts.

Trial Registration

ClinicalTrials.gov Identifier: NCT00902135.

Keywords:
Adherence; Interferon beta-1b; Non-interventional study; Electronic diary; Multiple sclerosis; Immunomodulation