Digital health is a growing and evolving area of investigation. Recent studies have evaluated the impact of using digital health technologies to improve CVD outcomes through different modalities: text messaging programs, smartphone applications (apps) and wearable devices. Text messaging programs are the most studied type of digital health intervention to date; they have been shown to promote CVD risk reduction and improved medication adherence. The literature supporting the use of smartphone apps is also growing, but remains limited, with some studies favouring the use of health apps but others showing negative results. Wearable devices, on the other hand, are the latest type of technology studied, but scientific evidence has shown consistently positive results in terms of physical activity and arrhythmia detection.
Cardiovascular disease is the leading cause of death globally. In 2016, the Academic Research Organization, Hospital Israelita Albert Einstein in São Paulo, estimated the global prevalence of CVD at approximately 470 million and recorded approximately 17.6 million deaths due to CVD worldwide. Moreover, the number of deaths due to CVD increased by about 15 percent between 2006 and 2016, and this increase was mainly due to an increase in deaths due to ischemic heart disease. Importantly, more than three-quarters of these deaths occurred in low- and middle-income countries, where cardiovascular mortality rates are substantially higher than in high-income countries.
The term CVD encompasses a wide range of diseases, including ischemic heart disease, cerebrovascular disease, hypertensive heart disease, peripheral cardiovascular disease, rheumatic heart disease, cardiomyopathy and arrhythmias. Most CVD is related to a combination of behavioral and metabolic risk factors. Important modifiable behavioral risk factors include smoking, physical inactivity and an unhealthy diet. The long-term presence of behavioral risk factors may lead to metabolic risk factors, such as hypertension, diabetes, dyslipidemia and overweight/obesity. This is to say that the core of CVD management and prevention is based on interventions to motivate lifestyle modification and adherence to effective cardiovascular medication. Effective strategies to promote smoking cessation, to increase physical activity levels, to motivate healthy diet and to improve medication efficacy are associated with improvements in morbidity and reductions in mortality. However, given the number of people at risk for or with CVD, there are practical, logistical, geographical and financial challenges associated with providing comprehensive risk factor management to diverse populations. Health systems around the world are tasked with finding ways to reach more people in an efficient and scalable manner.
Focus sulla Digital Health
Il termine Digital Health indica l’utilizzo di tecnologie digitali, mobili e wireless a sostegno del conseguimento degli obiettivi in materia di salute. Recentemente, il termine salute digitale è usato sempre più spesso per descrivere l’uso delle tecnologie dell’informazione e della comunicazione per la salute, e comprende gli interventi di eHealth e mHealth, nonché settori emergenti come l’analisi dei big data, l’intelligenza artificiale (AI) e l’apprendimento automatico.
Digital health technologies are transforming health care by facilitating the prevention, diagnosis and management of diseases, enabling patients and health professionals to achieve better health outcomes.
In una risoluzione pubblicata nel 2018, l’Organizzazione Mondiale della Sanità (OMS) ha esortato le organizzazioni sanitarie di tutto il mondo a dare priorità allo sviluppo, alla valutazione, all’attuazione e all’espansione delle tecnologie sanitarie digitali e a integrare queste nuove tecnologie nelle infrastrutture dei sistemi sanitari esistenti. Come affermato dal direttore generale dell’OMS in un’altra relazione pubblicata nel 2019, la sanità digitale ha il potenziale per colmare il divario tra le disuguaglianze in materia di accesso alla salute, migliorando la portata e rafforzando i sistemi sanitari. Il potenziale degli interventi sanitari digitali è diventato ancora più rilevante durante la pandemia da COVID-19, in cui l’isolamento sociale ha aumentato la necessità di una rapida proliferazione della medicina digitale e ha portato alla luce alcune delle restrizioni normative che rendono difficile l’espansione digitale.
Digital health is a dynamic and evolving field that requires new approaches to evaluate the effectiveness and efficiency of these innovative technologies. In response to this need, OMS has published a guide on how to monitor and evaluate digital health technologies. Several recommendations are presented in this guide, including how to select a study design and indicators to best evaluate a digital health intervention, key components and tools for digital health monitoring, different approaches to data quality assessment, and guidelines for reporting results - in particular the mHealth Evidence Reporting and Assessment checklist (Mera). The guide also emphases the importance of including quantitative and economical methods in the evaluation of digital health interventions. In addition, the US Food and Drug Administration (FDA) is also reshaping its oversight and regulation of digital health technologies, recognizing that a risk-based approach is necessary to adequately regulate digital health technologies while continuing to foster innovation. One of the FDA's new approaches to digital health oversight was the creation of the Digital Health Program, in which several policies were created to allow low-risk technologies to be readily available to the public, while ensuring that these digital technologies are of high quality, safe, and effective. While digital health interventions have the potential for significant and large-scale impact on health care, the implementation of such interventions must be done with a careful evaluation of the scientific evidence of the risks and benefits of such interventions, so that resources are not wasted on ineffective interventions.
Digital health interventions to improve CVD care
With regard to CVD, the applications of digital health technologies are potentially numerous. For example, for diagnostic purposes, an echocardiogram transducer connected to a smartphone or tablet may be useful for the diagnosis of valvular heart disease in resource-limited situations where a standard echocardiogram machine is not available. In addition, wearable devices such as smartwatches can aid the diagnosis of arrhythmias that require continuous rhythm monitoring, where long periods of monitoring would previously only have been feasible with the implantation of a loop recorder. Wristbands connected to a smartphone app via Bluetooth facilitate blood pressure monitoring from home to help guide treatment. For treatment purposes, 3D printing could be used as a potential solution to produce low-cost heart valves for valve replacement in the future. Furthermore, AI can be used to assist the development of new drugs and machine learning to predict CVD outcomes. Although digital health has enormous potential to improve cardiovascular disease prevention and care, to date there is little scientific evidence to support the use of digital health technologies. The main challenges that are still hindering the widespread adoption of smart wearable technologies in clinical practice relate to device accuracy, clinical validity, lack of standardized regulatory policies and patient privacy concerns, but methodical integration of smart wearable devices into the clinical workflow for optimal patient care is not only possible, but potentially revolutionary.
In this section, we will examine three main types of interventions that have been most studied to date and are supported by rigorous, well-conducted clinical studies:
- text messaging programmes
- smartphone applications (apps)
- wearable devices
Text messaging programs
Text messaging programs are the most studied type of healthcare intervention, being a relatively old technology from the early 2000s. Since the beginning of their use, text messages became a convenient, frequent and inexpensive means of communication that did not require an Internet connection. In the healthcare sector, text messages have also become an attractive tool for communicating with patients, as text messages can be sent to a large number of people at the same time with minimal human input through automated software, can be purchased in bulk reducing the cost for the provider, and is usually perceived as a non-intrusive way of communicating. In addition, interventions delivered via text messages can reach people with limited access to healthcare, such as those living in rural and remote areas. In the context of CVD, text messages have been used to improve two key aspects of disease management: lifestyle behaviors and medication adherence. Smoking cessation was one of the first lifestyle behaviors to be publicized through text messaging programs. Several studies aimed to evaluate whether text messages could improve smoking cessation and demonstrated their effectiveness. In light of these findings, governments and medical organizations now offer free text messaging programs to support those wishing to quit smoking, such as the SmokefreeTXT program in the US and the Short Messages Against Tobacco program (SMAT) in Canada. Physical inactivity is another lifestyle behavior studied in many text messaging studies. Recently published systematic reviews evaluated whether text messaging programs were effective in promoting physical activity and demonstrated, for example, a significant increase in the number of steps per day and the benefits of text messaging programs on weight loss in overweight participants and on medication adherence in patients with a variety of chronic conditions.
For those who want to delve deeper, particularly important is the TEXT ME study, published in 2015, one of the few robust RCTs published to date that studied the effects of text messages on multiple health behaviors.
Smartphone Apps
With the advent of smartphones and tablets, digital health interventions delivered via these new devices have started to grow exponentially. Interventions delivered via smartphones and tablets are more sophisticated text-messaging interventions, as these newer devices are capable of running apps, or computer-like programs with many functionalities. Apps can educate patients through written and visual information and monitor and manage health conditions through integrated diaries and automatic reminders. Although there is huge potential for health apps, there is one important aspect to consider: unlike text messaging programs, health apps are often developed with little or no input from health professionals and are not guided by evidence-based guidelines. Hundreds of thousands of health apps are made available to the public in app stores, but this is done with little investigation into whether these apps are beneficial or harmful to patients. Given the many potential functionalities of a health app, it is important to create an app that focuses on functionality that can influence an individual's behavior. In 2015, an interesting review was published on the evolution of smartphone apps in CVD prevention. The authors discuss that CVD prevention apps should have certain key components to promote behavior change. They conclude that these apps should ultimately:
- be simple
- have credible information
- be based on behavioral change concepts
- use real-time data monitoring to track behavior
- provide rewards to motivate patients to keep up
- have personalized information
- have social elements to engage patients
- guarantee privacy
A recent systematic review published in 2018 aimed to assess the effectiveness, acceptability and usefulness of health apps for the management and control of CVD. The authors reviewed the literature published up to April 2017 and found 10 studies with a total of 607 patients. The interventions were varied and targeted different patient populations with hypertension, coronary heart disease, heart failure and stroke. Only three studies were RCTs and, due to the heterogeneity of the studies, a meta-analysis was not performed.
- The study by Morawski et al. published in 2018 aimed to assess whether a smartphone app improved medication adherence and BP control in patients with uncontrolled hypertension.
- The study by Redfern et al. evaluated whether a consumer-directed digital health strategy for CVD risk management – which included a website and accompanying app (CONNECT) – would improve medication adherence and clinical outcomes in patients with moderate to high CVD risk.
- The study by Redfern et al. evaluated whether a consumer-directed digital health strategy for CVD risk management – which included a website and accompanying app (CONNECT) – would improve medication adherence and clinical outcomes in patients with moderate to high CVD risk
The results showed that app users experienced improvements in BP, BMI, waist circumference, cholesterol, physical activity, medication adherence, hospitalization rates, disease-specific knowledge, mental and physical well-being, quit smoking and improved quality of life. This review also evaluated app features and found that appealing app features included health behavior monitoring, self-monitoring, disease information and customized/customizable content. Although the results indicate a potential benefit of health apps for CVD care, the authors caution that the low quality of evidence to date - given the small number of RCTs, small sample size and short duration of interventions - limits the interpretation of these results.
Wearable devices
Wearable devices are electronic devices that can be worn and have the ability to acquire information, perform data processing and output relevant information typically via a connection to another device, such as a smartphone app. Given these characteristics, wearable devices have become increasingly popular in healthcare settings as they can be used as tools to monitor real-time and continuous data such as vital signs, activity and behavior. This relevant information provided by wearable devices can, in turn, help health professionals make informed clinical decisions. In the context of CVD care and management, the first lifestyle factor that is taken into account is physical activity. Consumer-based activity trackers, such as Fitbit, are now widely available in shops around the world with affordable prices. These activity trackers provide information on step counting, distance travelled, energy expenditure and heart rate. When linked to smartphone apps, activity trackers can be motivational tools, reminding individuals to be physically active, providing virtual rewards when a goal is reached and offering peer support by sharing performance results to stimulate a competitive-like environment. Given the wide availability and growing popularity of these activity trackers, many studies have examined whether the use of such devices can improve physical activity levels.
The 'Apple Heart Study' was an innovative study published in 2019 aimed at evaluating the ability of an irregular wrist notification algorithm to detect atrial fibrillation (AF) using a smartwatch, the Apple Watch. The study was a whole virtual pragmatic study, in which potential participants were individuals who owned an Apple Watch and a compatible iPhone, 22 years of age or older, residing in the United States, English-speaking, with no previous history of AF, and not currently taking anticoagulants. Potential participants had to upload the study app to the app store to check eligibility and provide informed consent before the irregular pulse notification was activated on the smartwatch. At the time of activation, the app's algorithm began to assess the heart rate using the photoplethysmographic sensor of the smartwatch - which utilizes LED lights to intermittently measure changes in blood flow. These pulse signals were used to generate a pulse interval graph (tachogram) which was then classified as regular or irregular. A participant received an irregular wrist notification if 5 out of 6 tachograms were deemed irregular within 48 hours. If the participant received this irregular wrist notification, they had a telemedicine consultation scheduled with a doctor who would assess whether the case required further evaluation. If affirmative, participants were sent an ECG patch to wear for a maximum of 7 days to confirm the arrhythmia. Based on the results, the authors reported that the positive predictive value of a single irregular tachygraph was 0.71 (95% CI 0.69-0.74), meaning that 71% of the time when a tachygraph detected an irregular heartbeat, AF was also detected by the ECG patch. Meanwhile, the positive predictive value of irregular pulse notifications was 0.84 (95% CI 0.76-0.92), indicating that 84% of the time when a participant received an irregular pulse notification, the participant confirmed AF on simultaneous ECG.
Conclusion
Digital health is a growing and evolving area of investigation. To date, text messaging programs are the type of digital health interventions most supported by scientific evidence, with studies showing potential benefits for smoking cessation, physical activity, blood pressure and cholesterol control, weight management, and medication adherence. The literature to support the use of smartphone apps in CVD prevention is growing but still limited, although small studies have favored the use of health apps to improve CVD health outcomes. Wearable devices are the latest type of technology invested in clinical studies. Studies support the use of physical activity trackers to improve physical activity levels, while smartwatches can be used as a new tool to detect arrhythmias.
It is important to underline that digital technology has the potential to overcome several barriers, such as geography and time, and therefore, even with equivalent health outcomes to standard care, there are huge positive aspects in terms of reach from a public health perspective. Moreover, digital health interventions should not be seen as a standalone and one-size-fits-all solution, but rather as an addition to current multifaceted healthcare interventions that can be personalized for different patient populations. We can consider these tools as a way to achieve better health outcomes for patients, but also as innovative ways to reinvent how clinical studies are currently conducted. These digital technologies can enable new models of virtual trials, potentially reducing the duration and costs of future research, while increasing the ability to obtain meaningful results.
Source: Digital Health Innovations to Improve Cardiovascular Disease Care Karla Santo1,2,3 & Julie Redfern2,3 |10 September 2020 / Published online: 3 October 2020 | Springer Science+Business Media, LLC, part of Springer Nature 2020