Wearable Technology: Innovation, Adherence, and Clinical Outcomes

The Innovation Issue Feature: The Future of Healthcare (Part 1)

Wearable technology is one of the fastest-advancing sectors in the broader technology industry, providing innovative solutions for patients and healthcare professionals alike. Eighteen percent of the people in the United States utilize digital health wearables to manage or monitor their well-being, with 35% using mobile applications.¹ With applications ranging from basic fitness trackers and smartwatches to devices designed for disease prevention and health maintenance, wearable devices are empowering patients and generating real-time data that could, in theory, provide critical updates to health practitioners on demand. The possibilities of the tech seem infinite, with implications that can potentially reduce patient costs while simultaneously improving both quality of care and clinical outcomes.

The vast data generated by wearable devices present tremendous opportunities for researchers who can apply machine learning and artificial intelligence to interpret, analyze, and manage it. However, the technology also poses challenges, such as user acceptance, data security, and ethical concerns. These issues must be mitigated for wearable tech to become usable for practical, everyday use within the healthcare industry. 

Wearable technologies enable the continuous monitoring of human physical activities and behaviors, as well as physiological and biochemical parameters of daily life. The most commonly measured health data include vital signs (e.g., heart rate, blood pressure, body temperature, blood-oxygen saturation), as well as posture and physical activities. Wearable devices can be integrated into shoes, eyeglasses, jewelry, clothing, accessories, and, what is currently most widely used and accepted, into a watch interface. More highly integrated wearable technology is also in development, with applications ranging from skin to neurointegration.

Empowering Patients and Doctors Alike

Healthcare has become more connected in recent years, and wearable devices are paving the path toward an even more connected future. As patients demand higher-quality care that is more convenient and accessible at an affordable cost, wearable devices may play a pivotal role in keeping patients informed of their health while also providing aggregated physiological data to healthcare providers. Telemedicine and connected devices have emerged as technologies that can provide greater access and convenience and serve as a means to defer in-person treatment and consultation in favor of remote care experiences. Sophisticated sensors in wearable devices allow for the collection, storage, and management of a repository of patient data, which can then transmit to patients’ healthcare providers to optimize tracking of key data points for various medical conditions. This allows for more accurate diagnoses and timely and personalized treatment plans, resulting in more favorable clinical outcomes.² 

Wearable devices also have implications in reducing prescription costs and increasing efficacy, as data relayed to doctors can empower these medical professionals to avoid overprescribing drugs that are suboptimal and modify therapies without requiring patients to make a trip to the office — in this way, wearables can provide cost savings on appointments and drugs alike.

One in six adults owns a smartwatch, and sales continue to grow annually.² In 2019, sales of smartwatches increased by 60% from the previous year, and the market is projected to reach $31.3 billion by 2023.² While technological innovations typically appeal more to younger consumers, the benefits of being able to transmit real-time health data to physicians, as well as be acutely aware of one’s current health parameters, have seniors adopting the technology at a similar rate as younger people.² 

The Costs of Patient Nonadherence

Medication nonadherence not only affects clinical outcomes, but it also drives substantial healthcare costs. In 2010, the costs of healthcare in the United States exceeded $2.7 trillion and accounted for 17.9% of the gross domestic product, and it is estimated that 20–30% of U.S. healthcare spending is ultimately wasteful.³ Providers and administrators must contain costs by reducing waste and improving the effectiveness of the care they provide. 

Patient nonadherence to prescribed medications is associated with poor therapeutic outcomes, disease progression, and billions of dollars per year in direct healthcare costs.³ It is estimated that nonadherence alone costs the healthcare system $300 billion annually.⁴ It is also estimated that 20–30% of prescriptions are never filled, and approximately 50% of medications for chronic diseases are not taken as prescribed.⁵ This results in an estimated 10% of overall hospitalizations, costing between $100 billion and $289 billion annually, in addition to 125,000 deaths per year.⁵ 

Exercise Adherence Is Below Recommendations

The benefits of physical activity (PA) to manage health conditions of patients with chronic diseases are well known. However, adherence to PA guidelines in patients remains low.⁶ Wearable technology presents a significant opportunity to increase exercise adherence to those who experience difficulties in participating in regular and substantial PA, and the technology could be supportive in increasing the success of exercise programs and interventions. The concept “exercise is medicine,” as defined by the American College of Sports Medicine (ACSM), has been widely accepted for the prevention and in some cases the treatment of chronic diseases, such as cancer, type 2 diabetes mellitus (T2DM), and cardiovascular diseases, as well as for people with disabilities.⁶ 

Low, moderate, and vigorous activities have been linked to reductions in the risk of T2DM, as well as reductions of inflammatory markers in breast cancer survivors.⁶ In cancer survivors, PA improves quality of life, cardiorespiratory fitness, and strength and alleviates fatigue.⁶ In chronic obstructive pulmonary disease (COPD) patients, PA is associated with better respiratory parameters.⁶ PA has a strong effect in reducing atherosclerotic factors, which are typical of cardiovascular diseases.⁶ Moderate to vigorous PA is associated with lower severity of pain and fatigue in women with fibromyalgia, and graded exercise therapy has shown benefits for myalgic encephalomyelitis patients.⁶ Exercise rehabilitation has also been shown to improve health-related quality of life for patients with heart failure, as well as to increase self-esteem and reduce stress in patients with chronic psychological disorders.⁶

Despite the evidence showing the importance of PA in preventing and treating patients with chronic diseases, adherence to guidelines is still well below the targeted threshold. Patients with a serious mental illness were less active than the general population, with only 9% of them reaching the recommended PA guidelines.⁶ A 2010 study found that, in Sweden, 84% of COPD, 74% of rheumatoid arthritis, and 72% of T2DM patients and 60% of healthy individuals did not adhere to PA guidelines.⁶ In a UK cohort of seniors, only 15% of men and 10% of women met PA guidelines, while only 5% of all adults in the United States participated in the recommended amount of daily PA.⁶

A 2019 study from the Hannover Medical School in Germany found telemonitoring of exercise to be effective in treating patients with metabolic syndrome. Patients in the study were given Garmin smartwatches to monitor physical activity over a six-month period and were observed to have significant increases in overall health, work ability, and quality of life. The researchers conducted a randomized, controlled trial wherein participants were randomly assigned to either an exercise group or a control group. Those in the exercise group were given an exercise supervisor, nutritional counseling, and a smartwatch to monitor their activity. 

The device measured their daily steps, heart rate, and general activity and reported the data back to the researchers. Baseline metrics, such as BMI, glucose levels, and lipid levels in the blood, were taken, as well as heart rate and blood pressure, while participants rode exercise bikes to measure exercise capacity. The researchers found that those in the exercise group averaged 9,612 steps per day and 147 minutes of exercise per week, with 48% of them achieving the recommended 150 minutes of daily exercise.⁷ Among those who exercised, average waist circumference decreased by 4 cm, triglyceride levels decreased by 25 mg/dL, systolic blood pressure decreased by 2.7 mm Hg, and fasting glucose concentration decreased by 5.4 mg/dL.⁷ The researchers concluded that these findings indicate the potential benefits of personalized and digitally monitored activity programs in treating patients with metabolic syndrome.

Smartwatches Increase Adherence in Heart Patients

Wearable devices that offer reminders, allow users to set goals, and contain elements of gamification have been found to increase PA among those who wear them. They can also provide a substantial lift to quantifiable metrics pertaining to both the amount of activity and positive clinical outcomes.⁸ Patients with atrial fibrillation (AF) who received smartwatch notifications in addition to standard care have better adherence to oral anticoagulation compared with those who received standard care alone, according to data presented at the virtual Heart Rhythm Society Annual Scientific Sessions.⁸ 

In a multicenter, prospective, randomized controlled trial at the Beijing Chao-yang Hospital at Capital Medical University, doctors analyzed data from 160 patients with AF who were assigned a smartwatch reminder. Patients in the standard care group were scheduled for outpatient visits and received regular follow-up calls. Those in the smartwatch reminder group received daily intake reminders and nonadherence smartwatch notifications of missed or delayed doses in addition to standard care. These patients also had the ability to use an immediate telephone feedback function.

Adherence was assessed using the Morisky Medication Adherence Scale (MMAS), a self-reported measure, and the proportion of days covered, an objective measure. A score of 8 on the MMAS indicated adherence, in addition to a cutoff of 80% or greater for proportion of days covered. During nine months of follow-up, both groups were taking approximately four drugs each for antiarrhythmic and antihypertensive treatment. In patients assigned standard care alone, the percentage of those with an MMAS score of 8 decreased from 66.3% in the first month to 40% at nine months.⁸ 

A similar trend was noted for the proportion of days covered by 80% or greater in this group, which decreased from 75% in the first month to 30% at 9 months.⁸ Conversely, the percentage of those with an MMAS score of 8 in patients assigned smartwatch reminders increased from 62.5% at one month to 77.8% at nine months.⁸ The number of patients with a proportion of days covered with 80% or greater was more than 90% throughout the 9-month period. The study concluded that a smartwatch that can send medication reminders can significantly improve adherence to oral anticoagulation therapy in patients with AF.⁸

Cardiovascular disease (CVD) remains the leading cause of death in the United States, as well as in many countries around the world.⁹ Vulnerable populations, including minorities, low-income groups, and people living in communities with limited access to nutritious food and facilities to participate in physical activities (such as gyms) are especially susceptible to CVD.⁹ Studies of these vulnerable populations show that behavioral interventions targeting one or more of these modifiable risk factors can improve overall cardiovascular health, albeit with challenges pertaining to patient adherence to clinical recommendations.⁹ Wearable tech, including activity-monitor systems, are a promising modality for targeting physical activity in behavioral interventions, as they hold the promise of connecting patients to clinicians right when needed, without the need for face-to-face interaction. As consumer ownership of wearable devices that collect real-time behavioral data becomes more ubiquitous, opportunities for clinicians to promote behavioral adherence continue to expand. 

A study conducted by Evidation Health and based on claims filed through Humana concluded that individuals who engage in activity tracking have significantly higher medication adherence than those who do not track their activities when controlling for age and sex across thousands of people with diabetes, hypertension, and dyslipidemia.¹⁰ The results were not dependent on a specific condition or tracked activity, but the positive association with medication adherence extended to the frequency of activity tracking as well as to physical activity level, as measured by step count. The study evaluated medical and pharmacy claims from roughly 8,500 patients who use activity trackers like Fitbit, Garmin, Jawbone, and Apple products. According to the researchers, people using activity trackers were more compliant with medication adherence than those who weren’t using mobile health tools.¹⁰ Additionally, medication management improved as these people tracked their activity more frequently. Health systems like Cedars-Sinai in Los Angeles and the Dana Farber Cancer Institute in Boston have seen success using Fitbits and other devices to collaborate with patients and reinforce care management outside the hospital or doctor’s office.¹⁰

Companies Driving Adherence Through Modern Innovation

In December 2018, Jason Oberfest, former CEO of the medication tracker startup Mango Health, joined Apple’s health team to possibly help the company scope out opportunities in the medication adherence market. The Mango app helps patients track and manage their medications, and Oberfest’s experience merged with Apple’s other health efforts, such as the Apple Watch, which now offers two features approved for medical use.¹¹ In a related move into healthcare, Apple also hired M. Osman Akhtar, the former COO of the Minneapolis-based nonprofit hospital network Fairview Health Services. Since these hires, Apple has also recruited dozens of doctors to expand its digital health products, grown its employee health and wellness clinics, and rolled out a long-anticipated Apple Watch equipped with an electrocardiogram (ECG), combined with the watch’s ability to detect and notify users of an irregular heart rhythm, and both features received FDA clearance.¹²

Apple’s biggest venture into healthcare to date is its Health app, which it launched in 2014 and now comes preinstalled on every iPhone. The app includes features such as activity tracking, sleep monitoring, and mindfulness support, but those built-in features are only a starting point. Apple has also created three kits that help developers build health-related apps for the iPhone and Apple Watch — HealthKit, which allows developers to feed information to and from the app and provides a framework for connecting new apps; ResearchKit, through which developers can create apps for medical research or clinical trials; and CareKit, aimed at connecting patients with providers.

In January 2018, Apple rolled out a feature that allows users to download, store, and share elements of their medical records and, in turn, participating providers can send lab test results, medication regimens, and other data directly to a patient’s iPhone. More than 39 providers have already opted in, including Cedars–Sinai, Geisinger Health System, Dignity Health, and Johns Hopkins Medicine.¹² At the same time, Apple also announced it was teaming up with several EHR vendors, including Athenahealth, Cerner, and Epic, to help users view their personal health records on their iPhones. Apple isn’t the first company to try to bring health records to mobile devices — Google, Microsoft, and others have tried, but Apple is in a unique position: its Health app is already installed on the phones of 140 million Americans,¹² it has strong associations with consumers for safeguarding the privacy of its users’ sensitive data, and it has a reputation as America’s consumer technology leader, with whom industry-leading healthcare companies seek partnerships. Soon after Apple released HealthKit, it announced that partners, including Duke University School of Medicine and Stanford University Hospital, were already using the technology to allow chronically ill patients to remotely track and manage their symptoms.¹² 

Because so many Apple users already use the Health app, the company can recruit patients rapidly and at a large scale for proposed medical studies — dramatically lowering costs for providers, pharmaceutical companies, and medical device manufacturers. One of the first examples is the Apple Heart Study, currently being conducted in partnership with Stanford Medicine, which compares Apple Watch’s ability to detect AF to standard detection methods. The study recruited more than 400,000 participants via their iPhones.¹² As Alan Yeung, medical director for Stanford Cardiovascular Health, explained, “To get 10,000 people enrolled in a medical study normally, it would take a year and 50 medical centers around the country.”

Duke University Health completed a study using the iPhone’s facial recognition technology to screen young children for autism and other neurodevelopmental disorders. The app was downloaded more than 10,000 times, and usable data was collected on 88% of the videos that parents uploaded.¹² In January 2019, Apple announced a multi-year partnership with Johnson & Johnson (J&J) to run a randomized control trial testing if the combination of the Apple Watch’s function with J&J’s patient engagement app can help detect and diagnose AF earlier in patients over 65.¹² 

The iPhone and Apple Watch are already sophisticated medical tools, offering features ranging from electrocardiograms (ECGs) to fall detection — creating an opening for providers to use the devices to involve their patients in monitoring and improving their health. As the iPhone and Apple Watch grow increasingly sophisticated, these partnerships could expand. The company has already provided Apple Watches for studies examining the device’s ability to monitor migraines, blood pressure, adherence in psychiatric care, and even as a virtual therapist for arm recovery in stroke patients.¹² Apple has also filed patents suggesting that future versions of its devices may allow users to measure blood pressure, body fat, and heart rate simply by pressing their finger on the screen.¹²

This fall, the tech giant announced the release of the sixth version of the Apple Watch. In addition to the FDA-approved ECG feature, Apple Watch 6 also comes with a pulse oximeter or blood oxygen monitor, which does not carry FDA approval because it is designed as a general wellness feature, as opposed to being intended for medical purposes.¹³ In an interview with Mad Money’s Jim Cramer, Apple CEO Tim Cook posed a rhetorical question about the future of his company: “If you zoomed out into the future, and you look back, and you ask the question, ‘What was Apple’s greatest contribution to mankind?’ It will be about health.”

Adherence in Healthcare Retail

In June 2015, Walgreens officially launched its app for Apple Watch that assists people in taking medications as prescribed through its Pill Reminder and Refill Reminder features.¹⁴ The Walgreens App for Apple Watch is designed to help patients manage their medications — from simple, once-daily reminders to multiple, complex drug regimens. The Apple Watch app connects with the user’s Pill Reminders inside the Walgreens iPhone app, and Apple’s “actionable alerts” allow the user to mark a medication as taken or skipped, as well as view which medications might have been missed or may be taken next. Refill Reminders predict when medication may be running low and offer users a one-touch method to initiate a refill. Users receive a follow-up notification when the medication is ready for pickup.

Walgreens competitor CVS has deployed a number of digital tools aimed at improving adherence and patient outcomes. The results of its first pilot of remote monitoring for patients with chronic myeloid leukemia (CML) found that participants in the two-way secure texting program were 22% more likely to be optimally adherent to their medications.¹⁵ CML patients must maintain 90% or better adherence to their medication regimens in the first year after diagnosis to significantly boost their chances at remission.¹⁵ In the program, patients were offered education and coaching on their medication through secure messaging. CVS’s specialty pharmacy team is also targeting wearables to improve adherence and outcomes. It launched a pilot trial using smartwatches with 27 patients with multiple sclerosis (MS), with 90% of the test patients using the watches actively over the course of a year.¹⁵ CVS found that 86% of participants regularly used the watches to report symptoms, and 75% took part in a walk test,¹⁵ which is key in monitoring how well-managed an MS case is. 

References

1. Safavi, Kaveh and Kalis, Brian. “How Can Leaders Make Recent Digital Health Gains Last?” Accenture. Aug. 2020. Web. 

2. Seymore, Brandeis. “Smart Specialty Wearable Devices Can Boost Patient Care.” Pharmacy Times. 03 Jun. 2020. Web. 

3. Iuga, Aurel O; McGuire, Maura J. “Adherence and Health Care Costs.” U.S. National Library of Medicine National Institutes of Health. 20 Feb. 2014. Web.

4. Aungst, Timothy. “Does Nonadherence Really Cost the Healthcare System $300 Billion Annually?” Pharmacy Times. 01 Jun. 2018. Web. 

5. Boylan, Lisa. “The Cost of Medication Nonadherence.” National Association of Chain Drug Stores. 20 Apr. 2017. Web. 

6. Albergoni, Andrea, et al.“The Role of Technology in Adherence to Physical Activity in Patients with Chronic Diseases Experiencing Fatigue: A Systematic Review.” U.S. National Library of Medicine National Institutes of Health. 12 Sep. 2019. Web. 

7. Carfagno, Jack. “Study Finds Smartwatch Use and Exercise Successful in Improving Overall Health.” DocWireNews. 14 Jun. 2019. Web. 

8. Dobkowski, Darlene. “Smartwatch Notifications Improve Medication Adherence for AF.” Healio Cardiology. 12 May. 2020. Web. 

9. Yingling, Leah; Mitchell, Valerie; Ayers, Colby; Peters-Lawrence, Marlene; et al. “Adherence with Physical Activity Monitoring Wearable Devices in a Community-Based Population: Observations from the Washington D.C., Cardiovascular Health and Needs Assessment.” Oxford University Press. 17 Jan. 2017. Web. 

10. Wicklund, Eric. “New Study Finds Link Between mHealth Wearables, Medication Adherence.” Xtelligent Healthcare Media. 18 Apr. 2019. Web. 

11. Haefner, Morgan. “Apple Hires CEO of Medication Adherence App: 3 Things To Know.” Becker’s Healthcare. 17 Dec. 2018. Web. 

12. Kimmell, Jackie. “The 5 Ways Apple Wants to Transform Healthcare.” Advisory Board. 22 Jan. 2019. Web. 

13. Staff. “Why Isn’t Apple Watch’s Blood Oxygen Feature FDA-Approved?” Government Technology. 08 Oct. 2020. Web.

14. “Walgreens Launches App for Apple Watch to Support Medication Adherence.” Business Wire. 08 Jun. 2015. Web. 

15. Minemyer, Paige. “How CVS Is Using Digital Tools to Boost Specialty Pharmacy Adherence.” Questex. 04 Nov. 2019. Web.

Read Part 2: Wearable Technology:
Targeting a Range of Uses and Indications

Read Part 3: Wearable Technology:
Their Future in Clinical Trials and the Real World