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There is an urgent need to tackle cardiovascular disease and digital therapeutics have the potential to provide an innovative and exciting opportunity to improve treatment strategies.

Cardiovascular Disease: Enhancing Current Treatments With a DTx

by Dr Nwamaka Osakwe, FWACP, MBBS 6 minute read

Cardiovascular diseases (CVD) such as heart failure, coronary artery disease, and arrhythmia affect approximately 86 million people in the United States alone, and remain the leading cause of mortality worldwide. CVD contributes significantly to morbidity, reduced quality of life, loss of productivity, and increased healthcare costs, all of which make it a significant priority for health systems across the globe.

Current strategies to manage the prevalence of CVD include identifying high-risk individuals and practicing early interventions to reduce their risk of developing a disease, as well as limiting the progression in individuals who already have cardiovascular disease. Despite the availability of highly-effective treatments, there is still an urgent need to tackle CVD. Digital therapeutic (DTx) interventions hold promise to further improve the quality and experience of cardiovascular care, and The Sidebar sets out to understand how and why this is possible.

Cardiovascular Disease: Why Medication Adherence Remains a Problem

Cardiovascular disease costs the US healthcare system around $363.4 billion each year. Lifestyle changes that include increased movement and eating a balanced diet can reduce the risk of CVD significantly. Despite the importance of lifestyle changes and medication, experts report non-adherence in around 60% of patients with cardiovascular disease. Furthermore, up to 50% of individuals who are initially adherent, stop taking their drugs within six to twelve months of commencing treatment. 

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But why are the numbers so high? Pharmacologic and nonpharmacologic factors can negatively impact treatment adherence and include:

  • Lack of understanding of the disease and the implications of skipping medicine. Patients who do not have a good understanding of their disease can have difficulty adhering to treatment. This is particularly problematic in patients who are asymptomatic and may fail to perceive the benefits of treatment or the potential risks associated with progressive disease.
  • Lack of motivation. Lack of motivation is a key contributor to poor adherence and may be caused by insufficient understanding of the disease, fear of the side effects, or a failure to perceive the benefits of specific interventions.
  • Complex drug regimens. Regimens made up of multiple drugs and multiple dosing are commonly associated with poor adherence. For example, when researchers retrospectively studied patients with hypertension over a two-year period, they found that adherence was better among those with fixed-dose combinations rather than single agent pills.
  • Poor access to healthcare. The cost of healthcare coupled with the distance from healthcare facilities can further contribute to poor adherence. Individuals with poor socioeconomic backgrounds are predominantly impacted by this barrier.

Cardiovascular Disease: Can DTx Make a Difference?

The Digital Therapeutics Alliance defines DTx as a “new category of medicine that delivers medical interventions directly to patients using evidence-based, clinically evaluated software to treat, manage, and prevent a broad spectrum of diseases and disorders.”  Because DTx solutions are promoted as a therapeutic intervention, they are subject to rigorous regulation by the U.S. Food and Drug Administration (FDA) and must be clinically validated to provide real world positive health outcomes.

The goal of DTx is to encourage positive lifestyle and behavior change and promote positive long-term health through the disease-specific programs. While basic wellness applications target general health, DTx solutions target a person’s specific medical condition such as heart failure, hypertension, coronary artery disease, etc. Depending on a person’s treatment plan, the solution might manage a specific diet or exercise routine, sleep, stress, and medication reminders. To date, the DTx arena has shown massive growth potential as Insider intelligence predicts a $56 billion global opportunity.

Research shows that DTx solutions can support self-management for people living with other health conditions, thus the potential for self-management of cardiovascular risk factors (e.g., movement, nutrition, mindfulness, etc.) is vast. Within the CVD space, digital therapeutics have the potential to have a significant impact in the following ways:

1. To facilitate behavior change

Health education requires time that clinical practices often cannot afford. With healthcare providers on a time crunch, it’s becoming increasingly difficult to include effective health education as part of consultations. DTx solutions can provide quality health education as and when the patient needs it. Education is delivered in bite-sized, digestible formats which patients can access at times convenient to them. 

Traditional treatment paths encourage lifestyle changes based on the premise that people will do the right thing when they know what to do. However, this is not always the case. For example, one study revealed that although participants were aware of the importance of healthy eating, they consistently told researchers that they struggled to follow a healthy diet. 

Patient education is crucial, but alone, it is not enough.

Digital solutions can support behavior change by educating patients and using daily challenges and reminders to help users maintain positive momentum. The HERB-DH1 pivotal trial demonstrates the potential of a DTx solution in this context, as patients using a solution reported lower blood pressure in the absence of antihypertensives compared to standard lifestyle changes alone.

2. To improve medication adherence

Many CVD prescriptions are complicated by polypharmacy, multiple dosing, and multiple instructions regarding use of medication. To further illustrate this point, patients living with heart failure are often required to take an average of 6.8 medications and 10.1 doses per day. Some people may find this regimen difficult to follow, but DTx can simplify this process for users through the use of in-app medication reminders.

Sidekick’s feasibility study for a novel therapeutic program for patients with peripheral artery disease recruited fourteen patients to receive a four-week intervention. Eleven patients remained active during the study period, and seven answered the pre and post questionnaire. When asked if they forgot to take their medication the previous week, the participants’ rating went from two before the program to 0.1 after the program. Additionally, five out of the seven patients said the platform helped them remember to take their medication.

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3. Remote patient monitoring by healthcare providers

Remote patient monitoring (RPM) is a technology that enables real-time tracking of health measurements, such as heart rate, blood sugar level, and temperature. RPM allows patients to communicate with healthcare providers (HCPs), promotes collaborative management between patients and providers, reduces unnecessary hospital visits and improves clinical outcome. Insider Intelligence predicts that 30 million US patients will use RPM tools by 2024, and the global RPM system market will be worth $1.7 billion by 2027.

Remote monitoring of people with CVD, such as heart failure, makes a vast difference to a condition that can quickly deteriorate.

With RPM, HCPs can monitor patients in real time and respond quickly without facing geographical limitations. One heart failure nurse was able to use RPM to track her patient and respond quickly at a time when distance would have been a barrier. 

4. Enriching clinical research

When used to support clinical trials, DTx can provide a wealth of data about CVDs and response to treatment. In turn, this longitudinal view of the diseases and the treatment patterns can help to improve patient outcomes and deepen understanding of the patient experience. Being able to monitor and collect data from patients beyond a brick and mortar trial setting reduces the need to travel, involves users actively in their care, improves how they manage their health, and assists in the concealment of allocation during the study. 

Hurdles That Need To Be Overcome

There is a strong focus on the opportunities relating to the implementation of digital solutions in cardiology, however HCP endorsement is a vital step in the process. A majority of participating HCPs in a 2019 survey held in the Netherlands expressed concern that digital health solutions might increase their workload; they expressed concern over lacking reimbursement models, and also expressed a need for integration of new and existing systems (e.g., medical records). Despite these legitimate concerns, HCPs are already seeing the potential benefits of DTx. In a recent survey of 200 US physicians on the willingness to prescribe DTx, 95% of the respondents said that they are likely to prescribe DTx. 

Concerns about digital health solutions have also been raised by patients with cardiovascular disease. The ESC e-Cardiology working group postulated that it is possible that these concerns could relate to health status, personal motivation, low digital literacy, low education, and low socioeconomic status. Environmental issues that could also hinder patient adoption relate to security and privacy, quality of care, accessibility to digital tools, and financial well-being. It has also been reported that concerns about receiving a poorer level of care due to the impersonal nature of digital services could pose a problem.

What Next?

There is little doubt that DTx solutions support contemporary cardiovascular healthcare delivery. The 2016 Innovation Strategy of the American College of Cardiology (ACC) states that ACC should be “leading the digital transformation of healthcare” and points to the need for effective and safe innovations aiming to improve efficiency of care and improve patient-physician relations, supported by reimbursement models. While there are indeed some concerns surrounding the implementation DTx in treatment plans, both HCPs and patients alike are demonstrating an increasing acceptance of digital healthcare. It’s hopeful that Dtx will be more widely adopted in the future in an attempt to enhance the treatment of CVD and achieve the benefits outlined above.

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