Assessment of Medication Adherence Using a Medical App Among Patients With Multiple Sclerosis Treated With Interferon Beta-1b: Pilot Digital Observational Study (PROmyBETAapp)

Volker Limmroth, Klaus Hechenbichler, Christian Müller, Markus Schürks, Volker Limmroth, Klaus Hechenbichler, Christian Müller, Markus Schürks

Abstract

Background: Accurate measurement of medication adherence using classical observational studies typically depends on patient self-reporting and is often costly and slow. In contrast, digital observational studies that collect data directly from the patient may pose minimal burden to patients while facilitating accurate, timely, and cost-efficient collection of real-world data. In Germany, ~80% of patients with multiple sclerosis (MS) treated with interferon beta 1b (Betaferon) use an electronic autoinjector (BETACONNECT), which automatically records every injection. Patients may also choose to use a medical app (myBETAapp) to document injection data and their well-being (using a "wellness tracker" feature).

Objective: The goal of this pilot study was to establish a digital study process that allows the collection of medication usage data and to assess medication usage among patients with MS treated with interferon beta-1b who use myBETAapp.

Methods: The PROmyBETAapp digital observational study was a mixed prospective and retrospective, noninterventional, cohort study conducted among users of myBETAapp in Germany (as of December 2017: registered accounts N=1334; actively used accounts N=522). Between September and December 2017, users received two invitations on their app asking them to participate. Interested patients were provided detailed information and completed an electronic consent process. Data from consenting patients' devices were collected retrospectively starting from the first day of usage if historical data were available in the database and collected prospectively following consent attainment. In total, 6 months of data on medication usage behavior were collected along with 3 months of wellness tracker data. Descriptive statistics were used to analyze persistence, compliance, and adherence to therapy.

Results: Of the 1334 registered accounts, 96 patients (7.2%) provided informed consent to participate in the study. Of these, one patient withdrew consent later. For another patient, injection data could not be recorded during the study period. Follow-up of the remaining 94 patients ended in May 2018. The mean age of participants was 46.6 years, and 50 (53%) were female. Over the 6-month study period, persistence with myBETAapp usage was 96% (90/94), mean compliance was 94% of injections completed, and adherence (persistence and ≥80% compliance) was 89% (84/94). There was no apparent difference between male and female participants and no trend across age groups. The wellness tracker was used by 21% of participants (20/94), with a mean of 3.1 entries per user.

Conclusions: This study provides important information on medication usage among patients with MS treated with interferon beta-1b and on consenting behavior of patients in digital studies. In future studies, this approach may allow patients' feedback to be rapidly implemented in existing digital solutions.

Trial registration: ClinicalTrials.gov NCT03134573; https://ichgcp.net/clinical-trials-registry/NCT03134573.

Keywords: BETACONNECT; digital observational study; interferon beta-1b; medication adherence; medication compliance; medication persistence; multiple sclerosis; myBETAapp.

Conflict of interest statement

Conflicts of Interest: VL has served as advisor or speaker or received research grants from Antisense, Allergan, Bayer, Biogen, Genzyme, Novartis, Roche, and TEVA. CM and MS are full-time employees of Bayer Vital GmbH (Leverkusen, Germany). KH is an employee of the Institute Dr. Schauerte (Munich, Germany). Bayer selected the Institute Dr. Schauerte for statistical analysis of the PROmyBETAapp study.

©Volker Limmroth, Klaus Hechenbichler, Christian Müller, Markus Schürks. Originally published in the Journal of Medical Internet Research (http://www.jmir.org), 29.07.2019.

Figures

Figure 1
Figure 1
Components of the BETACONNECT system. Republished with permission from Future Medicine Ltd, from Limmroth et al, 2018 [17]; permission conveyed through Copyright Clearance Center, Inc. BETACONNECT Navigator was not part of the PROmyBETAapp study.
Figure 2
Figure 2
(A) Mean compliance and (B) adherence over the 6-month study period. Bars in (A) indicate SD.

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