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

Abstract

BackgroundAccurate 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).ObjectiveThe 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.MethodsThe 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.ResultsOf 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.ConclusionsThis 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 RegistrationClinicalTrials.gov NCT03134573; https://clinicaltrials.gov/ct2/show/NCT03134573

Evaluating the Utility of Smartphone-Based Sensor Assessments in Persons With Multiple Sclerosis in the Real-World Using an App (elevateMS): Observational, Prospective Pilot Digital Health Study

“…In line with previous digital health feasibility studies, our results demonstrate that smartphone technology can be used to collect both sensor-based active measurements and passive data related to disease symptoms and severity in patients with MS [23,[31][32][33][34][35]. In contrast to previous studies, elevateMS collected data from a large, geographically diverse, remote, and unsupervised population, independent of scheduled clinic visits.…”

“…The results from this observational, remote data collection study demonstrate the feasibility and utility of a decentralized method to gather real-world data about participant's real-time life experience of MS through a digital health app, elevateMS. Compared with previous digital health studies in MS, elevateMS enrolled one of the largest remote cohorts with a self-reported or neurologist-confirmed diagnosis of MS from across the United States [23,31,32,34,35]. The sociodemographic characteristics of the enrolled patient cohort were broadly similar to the wider population of patients with MS [60,61].…”

“…Furthermore, by leveraging frequent and low-burden assessments, elevateMS and other digital health tools may facilitate regular patient monitoring between clinic visits. This could complement the existing clinical practice, by helping patients to record their symptoms, relapses, and medication usage more accurately and have an active role in their disease management; in turn, this has the potential to provide a more thorough assessment of disease, improve communication with health care providers, and ultimately support clinicians in developing personalized treatment plans [19,27,29,32,34,35]. More broadly and universally applied, this technology may also provide novel insights into the course of chronic and progressive conditions, as demonstrated by previous digital health studies in MS, asthma, and Parkinson disease [25][26][27]34].…”

“…In addition to monitoring symptoms and triggers, these studies have identified geographic and environmental factors related to disease severity, and have been reported by patients to have a positive impact on their disease management [26,27,29]. Several digital health studies have already been undertaken in patients with MS with encouraging results; data suggest that smartphone technology can be effectively leveraged to monitor MS symptom severity, QoL, and medication usage, enabling patients to play an active role in disease management [23,[31][32][33][34][35]. The recent FLOODLIGHT study has also shown that smartphone-based active testing can be used to remotely monitor motor function and capture MS symptoms, thus providing a more accurate assessment of MS in the real world [23,34].…”

Digital Health Integration Assessment and Maturity of the United States Biopharmaceutical Industry: Forces Driving the Next Generation of Connected Autoinjectable Devices

“…Some companies have taken a further step by creating entire platforms for their devices, including daily predictive forecasts and integrated and streamlined communication with health care providers and support programs. Expanding beyond this includes integrated sensors and apps enabling drugs to aid in chronic disease management, which can collect a variety of data from general adherence to pharmacokinetic and pharmacodynamic data that could better inform patients and their providers about usage behaviors to optimize drug adherence and treatment [9,42,43]. The next step will be fully connected DDCPs dispensed from the pharmacy, which has been seen with bioingestible sensors in oral medications and connected inhalers [44,45].…”