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Phones, Algorithms Boost Adherence to Stroke Meds

Smartphone camera confirms taking medication

Smartphone camera confirms patient is taking medication (AiCure)

10 April 2017. Results from a clinical trial show a smartphone-based remote monitoring program helps stroke patients stay on their blood clot medications and improve their health. Findings of the study, using technology made by AiCure, a New York-based health software company that sponsored the trial, appear in the 6 April issue of the journal Stroke, published by American Heart Association.

Stroke affects arteries feeding oxygen and nutrients to the brain, and when these blood vessels become blocked by a blood clot or rupture, the lack of oxygen and nutrients cause brain cells to die. Blood clots blocking arteries to the brain cause ischemic strokes, while rupturing blood vessels result in hemorrhagic stroke. According to American Stroke Association, stroke is the fifth leading cause of death in the U.S. and a key factor in many disability cases, since impaired brain functions can result in the loss of bodily functions. Some 795,000 people in the U.S. suffer a stroke each year, leading to nearly 130,000 deaths.

The study tested AiCure’s technology designed to help stroke patients stay on their medications, a key factor for success of direct oral anticoagulant drugs that help prevent blood clots, but rely on individuals to take these drugs as prescribed. The technology uses software loaded on mobile phones or tablets with the individual’s prescribed drugs and dosing instructions.

The software uses the mobile device’s camera to monitor the person actually taking the drug, which also provides reminders as the scheduled time for ingesting the drug approaches or warnings if the time window for taking the drug is closing. Designated clinicians receive text messages or e-mails if their patients are late, miss, or make an error in taking their drugs. Artificial intelligence is built into the computer-vision and analytical algorithms in the software.

The clinical trial enrolled 28 individuals at Montefiore Medical Center in New York recently diagnosed with an ischemic stroke and prescribe anti-coagulant drugs. Participants in the trial were randomly assigned to receive daily monitoring of their medication behavior with AiCure software on their mobile devices for 12 weeks, or go unmonitored for that period. The study team looked primarily at adherence to prescribed medication schedules, but also measured concentrations of anticoagulant drugs in participants’ blood.

The results show nearly all participants in both the AiCure and unmonitored groups took their medications, based on counts of those pills. In the AiCure-monitored group, however, the cumulative adherence rate was nearly universal at 97 percent, compared to 91 percent for those not monitored. In addition, blood samples from participants showed all participants (100%) monitored by AiCure were above the minimum efficacy levels for their drugs, while only half of the unmonitored participants reached the minimum thresholds.

The paper did not report on any adverse effects, but questionnaires given to the AiCure group showed participants rated their experience favorably as a tool for managing their medications and improving their relationship with physicians. The company says its software is registered with FDA as a Class 1-exempt medical device that “allows the solution to be widely distributed to large numbers of patients without the need to distribute customized hardware.”

“Many patients are unable to self-manage and are at increased risk of stroke and bleeding,” says Laura Shafner, AiCure’s chief strategist and a co-author of the study. “The use of technology and artificial intelligence has the potential to significantly improve health outcomes and reduce costs in clinical care.”

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