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13 Articles in Volume 18, Issue #6
Authorities’ Use of Big Data May Harm—or Help—Your Chances of Investigation
Gaps in the Pharmacist’s Pain Management Role
How can cyproheptadine manage complicated chronic pain cases?
Letters to the Editor: Trackable Pills; Buprenorphine; CRPS Diagnosis
Managing a New High-Dose Opioid Patient
Managing Opioid Use Disorder
Medication Selection for Comorbid Pain Management (Part 2)
Mobile Trackers and Digital Therapeutics
New Insights in Understanding Chronic, Central Pain
Nocebo Effects: How to Prevent them in Patients
Polarizing Topics in Chronic Pain
The Fight to End Peripheral Neuropathy
Urine Drug Monitoring

Mobile Trackers and Digital Therapeutics

Can mHealth apps improve the practitioner’s workday and help patients avoid OUD?

While many workers may jump at the chance to use automated tools and resources to help streamline their schedules, this may be a challenge for practicing clinicians. Long hours, travel, stringent record-keeping requirements, and emotional ups and downs are just a few of the obstacles that pain practitioners may face at the office.

Developers are looking to make more integrated technology a reality. As a new driving force in the healthcare arena, mobile health applications, or mHealth apps for short, are offering more accessibility and tailored programming with the clinical workday in mind. By providing a way to check one’s personal health, review diagnostic tests and medication compliance, and automate patient communication, mHealth apps are making bigger and better leaps into the modern physician’s workplace.

Why mHealth?

“Apps are going to play a greater role in healthcare delivery than people think,” said Tiziano Marovino, DPT, MPH, senior vice president of Health Strategy and Innovation at the Biogenesis Group in Ypsilanti, Michigan and PPM editorial advisor. “For example, we are already seeing remote monitoring of diseases such as diabetes and asthma using condition-specific platforms that not only monitor vital measures, but also alert medical offices and offer instantaneous advice for folks suffering from low blood sugar.”

Mobile apps provide a number of benefits. First, by quickly monitoring the behavior of the user, preferences and assessments can be set to adapt the app to the clinician’s individual needs. Second, most apps allow intervention in areas where behavioral decisions and barriers are most prominent. Finally, their large reach and social community atmosphere allow for a combined better health outcome. “The use of apps is also associated with a lowering of healthcare costs through prevention and early detection of more catastrophic events,” Dr. Marovino said.

However, there are some disadvantages to using mHealth apps. Studies show that the technology suffers from waning engagement over time, to which Dr. Marovino lists a few factors that may be at cause. These include: intrusive remote monitoring; worker distrust of the employer; a fear of data breaches; a fear of health-related punitive actions; perceptions of forced participation; social isolation; general disinterest or lack of motivation; and perceived non-importance or non-relevance.

In addition, despite their frequent use across a wide variety of health arenas, few mHealth app developers have conducted research to support their content or effectiveness. Additional evaluation is needed to understand the degree of outcomes, user compliance and response, and safety.

Brightr Study Seeks to Better Understand the User Experience

Researchers led by de Korte, et al, set out to fill some of these research gaps through the evaluation of an mHealth app called Brightr (Sense Health, Rotterdam, The Netherlands). This app was developed for high-tech company employees to improve their health and well-being. Brightr continuously monitors behavior patterns, with modules for mental resilience, sleep, physical activity (PA), nutrition, and shift work. The reviewers wanted to better understand the user experience by tackling questions around personal experiences with health and well-being interventions at work, general impressions of the app, and feedback on what would make such apps more appealing. Interviews and focus groups were conducted.

Overall, users recommended that future mHealth app developers consider consistency in system performance to influence user adoption and adherence; user relevancy and work context so that tailored characteristics are better understood; and clear privacy alerts. “I think it is incumbent on innovators to test their apps in the same way that we test medical devices for reliability, validity, responsiveness and overall impact on the population they intend to serve,” explained Dr. Marovino.

Adjustments Still Needed

“There is no doubt that medical apps have made remote monitoring of chronic diseases a possibility where once they required an actual face-to-face visit with all the resource intensiveness that occurs there,” Dr. Marovino said.

However, further studies on how users may remain more committed to such applications are needed. As pointed out by the Brightr study participants, the development of wearable sensors that can, in certain clinical contexts, provide improved opportunities for long-term tracking and patient engagement is also desired.

Companies such as A&D Medical (San Jose, CA) offer various wearable devices, such as blood pressure monitors, connected weight scales, and sleep trackers, that are all synched to one connected app. Others, such as Biotronik (Lake Oswego, OR), offer similar cardiovascular monitors that specifically aim to replace unnecessary doctor visits through early detection.

With current research on mHealth apps generating primarily neutral feedback, it is clear that certain limitations need to be addressed before these apps are widely adopted by practitioners. While they do offer a foundation for understanding key trends in the clinical workday, it is hoped that future apps may help clinicians implement healthier working strategies for themselves and more convenience for patient interaction and monitoring.

–Reported by Steven Aliano

Digital therapeutics may help patients avoid OUD

Will therapy delivered via mobile application change the treatment landscape for patients with opioid use disorder (OUD)? Pear Therapeutics (Boston, MA) and Sandoz (Novartis, Basel, Switzerland) think so; they recently announced a joint effort to develop and bring to market two such treatments, including one for individuals with OUD and one for those with a substance use disorder (SUD).1

What Are Digital Therapeutics?

Digital therapeutics are technology-based health products that aim to help healthcare providers and users. They include condition management software and sensor-enabled pills. Digital therapeutics can be used with—or in place of—other treatments. While there is no official definition of the term, digital therapeutic products should be clinically proven safe and effective, and approved by regulatory agencies when appropriate, among other criteria, according to the Digital Therapeutics Alliance, an industry organization of collaborating companies.2

Health conditions that respond to behavioral or psychological treatment may be “most ready” for digital therapeutics, said Peter Hames, CEO of Big Health (San Francisco, CA), a digital medicine company, in a recent interview with McKinsey & Company.3 A study found that prescription opioid users being treated with buprenorphine and cognitive behavioral therapy (CBT) fared better than those who did not receive the therapy.4 Companies like Pear and Sandoz, therefore, see digital therapeutics as the beginning of a new era in treatment options for OUD patients.

reSET-O and reSET

The companies have developed reSET-O5 for patients with OUD who are taking buprenorphine and reSET for patients with an SUD. The platforms consist of a mobile application for patients and a web interface for clinicians. 5,6

After downloading the application on a mobile device, “patients can activate the product with a prescription access code provided by their physician or medical provider,” explained Amanda Galgay, senior director of corporate communications and investor relations at Pear Therapeutics. The app delivers a “form of cognitive behavioral therapy designed for patients,” and helps “support and incentivize patients in achieving abstinence and retention in outpatient treatment.” For example, the program prompts patients to enter information about cravings, opioid use, and other metrics, while “the patient’s physicians or medical providers monitor the patient’s treatment and progress from a clinician dashboard as [patients] progress through various modules and responses to questions.”

Three randomized clinical trials conducted by Pear Therapeutics involved more than 450 OUD patients receiving medication-assisted treatment. Those enrolled in a program similar to reSET-O were more likely to be opioid-abstinent for longer periods of time, while also spending less time with a therapist, than those receiving face-to-face therapy.7

In 2017, reSET became the first digital prescription therapeutic to be FDA-approved to treat SUD.8 Meanwhile, reSET-O has expedited access pathway designation9 and is under regulatory review. “We anticipate clearance in the second half of the year (2018),” Galgay noted. reSET will be available via a renewable 12-week prescription; reSET-O is expected to be prescribed in the same manner.

How Suitable are Digital Therapeutics for Patients with OUD?

“I am excited about having another option to promote effective and accessible behavioral support for patients,” said J. Kimber Rotchford, MD, MPH, medical director of the Olympas Pain and Addiction Services clinic in Townsend, WA, and author of the books Opidemic: A Public Health Epidemic and Opioids In Chronic Pain Management: A Guide for Patients. (Read Dr. Rotchford’s patient primer on addiction versus physical dependence at practicalpainmanagement.com/patient/resources.)

“The benefits of digital support are accessibility, cost, and supporting evidence of its efficacy,” Dr. Rotchford said. However, he pointed out that “based on population studies, OUD responds best to medication-assisted treatment (MAT).”10,11,12 There is an “overwhelming evidence of efficacy” for the use of methadone, buprenorphine, and naltrexol (as well as other appropriate medications for people with multiple conditions) to treat OUD, Dr. Rotchford continued. “Opioid use disorder is a serious biological, physical, and medical condition that warrants both medication and behavioral supports.”

However, interventions that eschew medication concern him; the approach aligns with the “current cultural belief system that says that abstinence [as opposed to medication-assisted treatment] is best… There are immense cultural prejudices and biases when it comes to managing substance use disorders.” He warns, “Don’t discount the serious and significant potential of medications being of help.”

Still, digital therapeutics that aim to provide behavioral support can be of use. As Dr. Rotchford pointed out, it all depends on the patient. “There are so many contextual and individual variables that the best [treatment approach] is always individual,” he said, concluding that, a digital therapeutic could be a “win-win if it promotes appropriate behavioral changes that are consistent with [the patient’s] long-term well-being.”

–Reported by Elizabeth Michaelson Monaghan

Last updated on: September 7, 2018
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