Site-Perspectives on Patient Engagement: Solutions for NASH Trials

By Nadege Gunn, MD

Keeping track of patients in clinical trials has always been challenging for sites and sponsors. However, the COVID-19 pandemic has taken the challenge of patient engagement to new levels. Patients with fatty liver disorders such as nonalcoholic steatohepatitis (NASH) present numerous obstacles to program compliance in the best of times. Patient education is a challenge with all cohorts regardless of disease state. Compounding this difficulty is the fact that NASH patients usually suffer from multiple morbidities such as diabetes, metabolic syndrome, high blood pressure, high cholesterol, and others. COVID-19 has further complicated things by causing these patients to be wary of in-person clinical visits.

The bright-side of all of this is that the pandemic is forcing all of us – sponsors, study sites and the patients themselves – to get more comfortable with technologies that keep us connected, keep patients engaged in the study and keep the data flowing. This has been so important as we all seek to unlock new, safe, and effective treatments with promise to help the millions of people impacted by fatty liver diseases.

Technology to Maintain Personal Connection

Productive face-to-face interactions between clinicians and patients plays a significant role in the success (or failure) of any clinical trial. Physicians need to be able to put hands on patients and examine them with regularity in order to get a complete picture of the patient’s health and well-being. That said, it can be weeks in between clinical visits, and COVID-19 may serve to space clinical appointments out even further. While that in-clinic time is important from a physical examination standpoint, it can be difficult for study investigators to assess what patients have been doing in the days and weeks since they were last in front of one another. It’s not uncommon to learn in a follow-up appointment that a patient ceased their medication three or four days after the first dose, or that they’d been taking their medication incorrectly.

Remote engagement technologies are useful in helping to fill those information gaps. Site teams can interact with patients remotely in a number of ways, including televisits (either by phone or video conferencing) or through applications downloaded on a smartphone or tablet. Regular check-ins using these types of tools go a long way in keeping that personal connection between the study team and the patient.

Constant Monitoring

We at study sites have long wished for solutions that help us know what’s happening with patients when they’re not with us. As I mentioned before, many study clinicians have gotten used to getting unpleasant surprises in follow-up visits. Now, we can implement technologies that help to let us know quickly when adherence issues pop up. This way, we can reach out to the patient remotely and troubleshoot in the hopes of getting them back on track. To accomplish this, we’ve employed a range of options, all with their own sets of benefits for patients and data collection.

Fitness Trackers

Wearable devices that track patient activity and even diet history provide important data from NASH patients. Increases in physical activity can be signs that the medication is having positive effects on the patient’s energy level. Fluctuations in physical activity might identify the need for our study teams to check in with patients in case there might be a problem.

Tablets

Tablet devices can make it easier for patients to enter their patient-reported outcomes. Filling out this critical information can be a burden for patients, so any technology that makes it quicker and more straightforward will help produce better data.

Remote Medication Adherence Applications

Those of us at sites have long wished for solutions that let us know about patient adherence issues earlier, so that we’re not surprised in follow-up visits. Technology that helps patients remember when and how to dose and gives our study teams confirmation of dosing is useful. With this technology, we’ll know when a patient misses doses almost as soon as it happens, and we can then reach out to that patient – by phone, e-messaging or through smart device applications – to learn why a dose or doses were missed and work with them to find a solution.

Patients with fatty liver diseases participating in clinical trials can pose unique difficulties for study teams to manage. Technologies that make it easier for them to follow the study protocol are extremely useful. With COVID-19 further complicating issues by keeping some patients away from in-person clinic visits, these technologies which can help study teams engage patients remotely have become increasingly important. Maintaining high levels of patient engagement in trials has always been more important, and today’s pandemic adds to the challenge. By using remote technologies to help facilitate patient-clinician interactions, sites can help maintain the vital connection between patients and caregiver.

For more information about how technology can help impact NASH patients in clinical trials, watch our webinar, Considerations for Remote Assessment in NASH Studies.