June 14, 2016
4 min read
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Low-tech wearable device addresses issues with patient compliance

Gulden Ophthalmics is developing an easy to use, affordable, secure medication reminder system that targets patients without smartphones.

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A new modular device may help increase compliance rates among patients taking ocular medications.

A study by Okeke and colleagues showed that 45% of patients on glaucoma drops used them less than 75% of the time despite the fact that they knew they were being monitored and were provided free medication.

Gulden Ophthalmics, based in Elkins Park, Pa., has designed ComplyNow, a modular device that can be worn as a wristband or on a necklace or keychain. The unit reminds patients to take their medications via beeps and a flashing light.

“A huge problem in the glaucoma community is compliance,” Mike Cymbor, OD, FAAO, of Nittany Eye Associates, State College, Pa., told Primary Care Optometry News. “We can talk to the patient at length and explain the importance of drops, but once they leave the office, we really have no idea whether or not they are taking them. Even when they come in for their follow-ups, we can ask them about how often they take the drops, but we know from research that the answers may or may not be true.”

Okeke and colleagues concluded that, “Patients reported far higher medication use than their actual behavior,” and doctors’ ability to identify poorly compliant patients based on self-reporting or other subjective indications is poor.

Elliot Franz, general manager at Gulden Ophthalmics, told PCON that ComplyNow is designed to be low cost and simple.

“Our product is as bare-bones as possible, but it addresses the problem at hand and give us the data that we need,” he said.

James Grue, director of analytics for the Eye Care Registry, helped Franz design ComplyNow out of a need to remind patients to take their nutraceuticals for age-related macular disease progression.

How it works

Mike Cymbor, OD, FAAO
Mike Cymbor

The device is programmed to set off medication reminders at certain times, according to Franz. It includes only three buttons: yes, no and snooze. If the patient presses the snooze button, a reminder will activate at a preset time, such as 10 or 15 minutes later. The device can be programmed by an optometrist or technician, is encrypted and contains a unique hardware identifier number that can be used in the patient’s electronic medical record to track his or her compliance data.

Patients who take more than one medication will have colored stickers on their bottles that coincide with the color of the flashing light reminder, he said.

The device, which does not connect to the Internet, will internally track not only if the patient has taken the medication, but whether there is a delay between when they are reminded and when they take it, Franz explained.

“The measurements are recorded by the device, and upon the patient’s return to the doctor’s office, the information is automatically de-identified and uploaded to the Eye Care Registry. It is the registry’s goal to analyze the data and discover how compliance patterns can lead to positive or negative patient outcomes,” he said.

The registry will analyze unique patient statistics, organize data into subgroups and track specific populations, those with AMD, for example, Grue explained. The registry can analyze how many AMD patients a clinician has, how many have stable visual acuity, how many are improving or getting worse, and how many dry patients are converting to wet.

“In outcomes-based care, with stage 2 meaningful use, all electronic health records have to be able to report to registries because they allow you to do true outcomes-based medicine,” Grue said. “Any provider not reporting to a registry is not conducting outcomes-based medicine.

“What we are creating is a group of optometrists and ophthalmologists who are practicing population medicine at a higher level than other physicians across the country,” he added.

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Developing the device

Franz said Gulden’s primary market for ComplyNow is seniors and those who do not use a smartphone or have one with them at all times.

Device testing and development is still ongoing.

“We want to get as many people involved in development with prototypes, to gain patient and physician feedback on the design,” he said. “Doctors and patients can help us by going to the website for ComplyNowMed and leaving a comment.”

A modular design was chosen, keeping in mind patients who do not wear watches. Gulden also ensured that the beep frequency is loud enough for patients who are hard of hearing, and designers added a visual indicator with deaf patients in mind.

The release is set for winter 2017, Franz said.

Cymbor said the potential impact in the eye care field is large, as compliance is an issue that clinicians deal with every day in practice.

“There’s no patient that I wouldn’t recommend it for,” he said. “However, it does seem like the patients who do best with the device are already somewhat into gadgets or are tech savvy.”

“The ComplyNow system provides the opportunity to engage the patient and provider toward the common goal of improved adherence,” Jason Hall, MD, a glaucoma specialist practicing at the Medical Eye Center of Manchester, N.H., told PCON. “It was evident that the use of the prototype device caused my patients to be more invested in their treatment, especially those with more complex regimens. I appreciated the focus on patient data security while still obtaining useful long-term information.”

Gulden is beta-testing 25 units at five different sites, including Cymbor’s and Hall’s practices, to obtain critical patient feedback and make the device as simple as possible. Once the final product is rolled out, Franz said Gulden hopes to collect compliance data to share with researchers.

“I think it’s going to be a fun experiment...no one has completed a study on compliance of this size,” he said. “Most researchers look at prescription refills to monitor compliance. But we can monitor on the per-dose level and look at time delay on a massive scale – no one has done that before.” – by Abigail Sutton

Disclosures: Cymbor and Hall report no relevant financial disclosures. Franz is general manager at Gulden Ophthalmics. Grue is director of analytics and co-founder at Eye Care Registry and director of clinical outcomes at OD Excellence.