Study: MHealth Beneficial in Helping TB Patients Adhere to Meds

A mobile health platform that allows physicians to remotely monitor their tuberculosis (TB) patients’ medicine is more effective than directly observed therapy, according to a new study.

The study, published in PLOS Medicine, evaluated wirelessly observed therapy (WOT)-a novel patient self-management system consisting of an ingestion sensor, external wearable patch, and paired mobile device that can detect and digitally record medication ingestions. WOT is FDA approved and can be accessed by patients with a physician’s prescription and downloadable phone app.

TB is an airborne bacterial infection caused by the organism Mycobacterium tuberculosis that primarily affects the lungs, although other organs and tissues may be involved, according to the American Lung Association.

“Excellent adherence to TB treatment is critical to cure TB and avoid the emergence of resistance,” the study authors wrote.

The randomized trial of 77 participants with drug-susceptible TB in the continuation phase of treatment recruited from San Diego and Orange County Divisions of TB Control and Refugee Health, using ingestion sensor-enabled combination isoniazid 150 mg/rifampin 300 mg (IS-Rifamate) prescribed daily. 

“We tested the accuracy of WOT to identify ingestions and we also randomly assigned persons with drug-susceptible TB to receive the new system or the standard of care currently available, directly observed therapy, for supporting and confirming medication taking during TB treatment for periods up to 29 weeks,” says study author Amanda Tucker, of the University of California, San Diego, La Jolla, California.

The trial demonstrates that WOT was reported as highly accurate in recording medication ingestion (99.3%) and patients with active TB using WOT were confirmed as taking 93% of their daily prescribed doses as opposed to 63% using directly observed therapy.

“All the patients using WOT completed treatment, were cured, and preferred it to directly observed therapy,” says Tucker. “The system allowed patients to manage their own medication taking, preserving patient privacy and autonomy, but also enabled highly targeted treatment support from practitioners with permission.”

These findings indicate that novel sensor-based systems that use cell phones to remotely record digital data are as accurate as actually watching a person swallow their medications and can be used to confirm and support TB treatment seven days a week, compared to five days a week for the current standard of care available, according to Tucker.

“This technology does however still need to be tested over the full course of TB treatment,” she says.

Key medication changes are now in transition for multi-drug resistant (MDR)-TB regimens that would enable the first entirely oral treatment regimen, according to Tucker.

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“Major treatment principles included in these recommendations are social support to enable adherence to treatment to ensure a patient-centered approach to care,” Tucker says. “Our research demonstrates WOT is a self-management system that can provide near-real-time actionable information, allowing patient-centered care to support adherence. WOT has the capability of monitoring multiple drugs within complex regimens individually. It is vital that medication adherence support be incorporated in the use of novel oral MDR regimens. The findings of this study suggest that WOT technology offers advantages over directly observed therapy for adherence confirmation and support and that WOT should be incorporated into implementation trials of oral MDR regimens in global settings.”

Globally, it is critical that WOT be tested in high-burden TB settings, where it may substantially support low- and middle-income countries TB programs, according to Tucker.

“The current challenge in healthcare today is how we deliver better care at lower costs,” says Scooter Plowman, MD, MBA, MHSA, senior medical director, partnerships at Proteus Digital Health, Inc., the Silicon Valley company that produces the technology supporting WOT (ingestible and wearable sensors and the mobile applications).

“Using the technology that enables WOT, digital medicines, is one approach to enable such efficiencies. This high-tech solution can help deliver more differentiated care to ensure the right people get the right level of high-touch support-it’s not about replacing human intervention but optimizing when and how we use scarce resources,” Plowman says.

Digital medicines have been used commercially and/or studied clinically in dozens of health systems around the U.S. across several therapeutic areas with great success, according to Plowman. “As shown in this current randomized controlled trial with tuberculosis patients in Southern California, digital medicines drive better clinical outcomes, improve patient satisfaction, and ensure high levels of medication adherence. We believe these are key metrics most meaningful to healthcare executives today.”

Dr. Mark Cotton, distinguished professor of pediatrics and child health at Stellenbosch University and Tygerberg Children’s Hospital in Cape Town, South Africa, is an advocate of evaluating WOT in TB treatment.

“We must urgently evaluate the applicability of WOT in high-prevalence countries such as India and South Africa where treatment adherence rates are often poor due to geographical barriers, stigma and poverty,” says Cotton. “WOT could potentially be a lifesaver for millions.”

Digital medicines have been used across many different therapeutic areas, including oncology with oral chemotherapy; infectious diseases including HIV, hepatitis, and tuberculosis; and cardiometabolic conditions for treating hypertension, high cholesterol, diabetes, and early stage heart failure, according to Plowman.

“In hypertension, for instance there is also randomized controlled data proving better clinical outcomes and increased medical decision making, also with very high patient satisfaction,” he says. “Additionally, digital medicines are being used to treat certain mental health conditions currently with Abilify MyCite (aripiprazole tablets with sensor, Otsuka Pharmaceuticals).”