A recent study sponsored by Massachusetts General Hospital in collaboration with the National Multiple Sclerosis Society and Pillsy Inc. was based on the assumption that multiple sclerosis (MS) patients have variable adherence to MS medications, leading to challenges in achieving full efficacy of disease modifying therapies not to mention challenging the ongoing investigation to the extent of true treatment failures. While some patients don’t adhere due to a busy or active lifestyle, others may have cognitive impairments thus preventing them from organizing and planning a regular dose schedule. This study, involving digital decentralized elements, introduced an electronic pill call made by Pillsy to record pill taking, timing, as well as include alert-based reminders via the mobile app. The adherence data, captured by the app, is monitored and analyzed by a remote study team.
This particular clinical trial (NCT04130256) started at the end of 2019 and concluded recently. Involving a targeted 85 participants, the study was led according to the clincialtrials.gov disclosure by Farrah Mateen with Massachusetts General Hospital. However, Dylan R. Rice is also identified as being part of a global neurology group. The study actually involved participation of MS patients over the age of 18 at the Massachusetts General Hospital trial site between January 2020 to October 2020.
At the start of this study, the participants all completed standard forms such as health history, Montreal Cognitive Assessment, and a symbol digit modalities test as reported in Healio. The full study follow period duration was 3 months (90 days).
Supporting a hybrid approach (e.g. patients could show up on site or participate from the home) the investigational team gave the participants pill bottles with the electronic smart caps, randomizing them 1:1 to either A) remote smartphone app-based and bottle-based adherence monitoring alone or B) in combination with reminder alerts.
How did the study team define “perfect adherence?” They did so by identifying the actual number of days that the participant took the medication within an hour of the actual dose time and carefully monitored those study subjects that either ended taking their medication early, right on time or late, or for that matter those that failed to take any medication and then compared the overall adherence in the study arms.
Of the total participants, 42 were assigned to remote tracking and 43 to the tracking plus the Pillsy solution. A solid 81% opted for the virtual option meaning they participated from home.
Presented at the recent ACTRIMS virtual meeting, the presenters summarized that full adherence to MS-based oral disease-modifying therapy wasn’t uniform or that common among the study participants. While nonadherence was “more nuanced than simply missing doses,” the study led by Dylan R. Rice and colleagues was a randomized, virtual clinical trial involving the electronic pill bottle adherence versus the use of mobile health-based medication reminders targeting MS patients on oral DMTs.
Interestingly, so-called perfect adherence turned out to be higher with the tracking with reminders group (68%) as compared to the tracking only group (61.4%; P = .006) reports Healio. It turns out that individuals with MS adhere more to their medication regimen based on age. The older the MS patient, the more close they get to perfect adherence (P<.001)—put another way those in the more senior cohort of the study came closed to perfect adherence (73.1%) versus the younger cohort (60.2%; P= .004).
Interestingly, the team reported at the recent ACTRIMS virtual meeting that it’s certainly feasible to use the Pillsy solution a decent number of participants did experience frustrating issues involving the necessary synchronization of the smartphone and Bluetooth technology during this study, and this impacted some of the data (e.g. making it incomplete). Note this latter factor must be considered for any remote/virtual clinical trial—that is the risk of technical issues or glitches that can impact data quantity and quality.
However the principal investigator (Rice) did share that “virtual clinical trials for MS are novel but represent a viable option, particularly during COVID-19.”
The system from Pillsy was used for this MS patient study. They are a technology company that employs behavioral science and artificial intelligence-based monitoring and communication tools to help medical patients adhere to prescribed healthcare regimens such as taking their medications on schedule and with proper dosage.
Medication adherence is a real problem in America as according to one study back in 2012, a researcher named Regina M. Benjamin, MD estimated that medication non-adherence is a problem for up to 75% of Americans and causes potentially up to 125,000 premature deaths per year in the U.S. alone.
Call to Action: MS patients: let us know your thoughts on this study.