As clinical trials grow in number and complexity, wearables are becoming essential. They allow for remote patient monitoring (RPM) and can track multiple health metrics at once. This is crucial as the number of trial endpoints has increased by 10% in the last ten years. Let’s explore how using wearables in clinical trials helps accelerate medical research.
Wearables are taking the medical research world by storm. The use of wearables in clinical trials has grown by 50% from 2015 to 2020 (Marra et al., 2020).
Why are researchers so excited about wearables? Let’s break it down.
Real-time data collection and monitoring
Imagine getting a constant stream of health data from patients, 24/7. Wearables allow clinicians to monitor real-time data, so there’s no more waiting for patients to come in for check-ups or relying on their memory of symptoms.
Wearables don’t forget or exaggerate. They provide hard data without human error or bias. Combining wearable sensors and advanced software in clinical trials is one of the best ways to make sure the data is accurate (Seitz, 2023).
Cost-effectiveness and efficiency in trial conduct
Wearable tech in healthcare shows promise for better data collection and analysis-–it can improve disease understanding, treatments, and clinical trials (Izmailova et al., 2018).
By reducing the need for in-person visits and automating data collection, wearables can cut trial costs by up to 60% (Coravos et al., 2019).
How Wearables Are Used in Clinical Trials
How are wearables being used in real studies? Let’s look at some examples.
These devices can measure how much you move and how well you sleep. This data is valuable for studies on conditions like insomnia or chronic fatigue syndrome.
Remote patient monitoring and telemedicine integration
Wearables allow doctors to check on patients from afar. This is particularly helpful for patients who live far from research centers or have mobility issues.
In a study of patients with Parkinson’s disease, wearable sensors were used to track movement patterns. This allowed researchers to measure the effectiveness of a new treatment more accurately than traditional methods (Espay et al., 2016).
Challenges and Limitations of Wearables in Clinical Trials
While wearables offer many benefits, they also come with some challenges.
Data privacy and security concerns
With so much personal health data being collected, keeping it safe is a top priority. Researchers need to ensure that patient information is protected from hackers and unauthorized access.
Potential for data overload and interpretation issues
Wearables can generate massive amounts of data. Sorting through all this information and making sense of it can be overwhelming for researchers.
One study found that while 79% of clinical trials were interested in using wearables, only 39% felt confident in their ability to manage and analyze the data effectively (Walton et al., 2015).
Best Practices to Incorporate Wearables in Clinical Trials
To make the most of wearables in clinical trials, researchers should follow these best practices.
Select appropriate wearable devices for specific trial needs
Not all wearables are created equal. Researchers must choose devices that are scientifically relevant to the study’s endpoints and can gather precise, valid data.
The goal is to collect meaningful information that significantly contributes to the study’s outcomes and conclusions, rather than just monitoring for the sake of it (Rudo & Dekie, 2024). For example, a sleep study might need a device with advanced sleep-tracking capabilities.
Ensure data quality and validation
It’s crucial to verify that the data collected by wearables is accurate and reliable. This often involves comparing wearable data with data from traditional medical devices.
Train participants and researchers on proper device use
Develop robust data management and analysis protocols
With so much data coming in, having a solid plan for managing and analyzing it is essential. This may involve using specialized software or working with data scientists.
Steinhubl et al. (2018) researched how heart failure patients used wearable sensors to track daily activity. By carefully selecting devices and training participants, the researchers collected high-quality data leading to new insights about the progression of heart failure.
Future Trends and Innovations
What’s next for wearables in clinical trials? Let’s take a peek.
AI and machine learning integration for data analysis
Multi-modal sensors in wearables combine different types of sensors in one device to give a more complete picture of a patient’s health (Sietz, 2023). It can include body sensors, environmental sensors, and even imaging tech to gather a wide range of data for clinical studies.
Expanded use of wearables in decentralized clinical trials
More trials are moving away from traditional research centers. Wearables make it possible to conduct studies with patients in their own homes, opening up research to a wider group of people.
Potential for personalized medicine and treatment optimization
Wearables are becoming an integral part of clinical trials, offering new insights into patient health and treatment efficacy. These smart devices are likely to revolutionize medical research, leading to faster, more efficient, and patient-centric clinical trials. Who knows–the next big medical breakthrough might come from a small device you can wear.
References
Coravos, A., Khozin, S., & Mandl, K. D. (2019). Developing and adopting safe and effective digital biomarkers to improve patient outcomes. NPJ digital medicine, 2(1), 1-5.
Espay, A. J., Bonato, P., Nahab, F. B., Maetzler, W., Dean, J. M., Klucken, J., … & Papapetropoulos, S. (2016). Technology in Parkinson’s disease: Challenges and opportunities. Movement Disorders, 31(9), 1272-1282.
Izmailova, E. S., Wagner, J. A., & Perakslis, E. D. (2018). Wearable Devices in Clinical Trials: Hype and Hypothesis. Clinical Pharmacology & Therapeutics, 104(1), 42-52.
Marra, C., Chen, J. L., Coravos, A., & Stern, A. D. (2020). Quantifying the use of connected digital products in clinical research. NPJ digital medicine, 3(1), 50.
Seitz, S. (2023). Wearable sensors have already enhanced clinical trials and their impact in this market is only going to grow as technology advances. Find out what clinical trial applications and opportunities exist for your innovative wearable technology company. Sequenex. Retrieved from https://sequenex.com/blog/enhancing-clinical-trials-with-wearable-sensors-and-software-solutions/
Steinhubl, S. R., Waalen, J., Edwards, A. M., Ariniello, L. M., Mehta, R. R., Ebner, G. S., … & Topol, E. J. (2018). Effect of a home-based wearable continuous ECG monitoring patch on detection of undiagnosed atrial fibrillation: the mSToPS randomized clinical trial. Jama, 320(2), 146-155.
Todd Rudo, T., & Dekie, L. (2024). The Future Fit of Wearables for Patient-Centric Clinical Trials. Applied Clinical Trials, 33(4).
Walton, M. K., Powers, J. H., Hobart, J., Patrick, D., Marquis, P., Vamvakas, S., … & Burke, L. B. (2015). Clinical outcome assessments: conceptual foundation—report of the ISPOR Clinical Outcomes Assessment–Emerging Good Practices for Outcomes Research Task Force. Value in Health, 18(6), 741-752.
Wearable Technology Clinical Trials: All You Need To Know About 5 Wearable Devices And Wearable Sensors. Learning Labb Research Institute. (n.d.) Retrieved from https://llri.in/wearable-technology-clinical-trials/
The global market for prescription digital therapeutics (PDT) is expected to grow to $17.16 billion by 2030. This growth is mainly due to the affordability of digital health technology for both healthcare providers and patients, as well as the increasing use of smartphones in both developed and developing countries.
In this article, we’ll describe PDT, its applications, benefits, and challenges.
Prescription digital therapeutics (PDTs) are a new class of medical interventions that leverage software to treat, manage, or prevent diseases and disorders. Unlike typical health apps, PDTs require a prescription from a healthcare provider and are subject to rigorous regulatory scrutiny.
According to the U.S. Food and Drug Administration (FDA), prescription digital therapeutics are medical devices, also called Software as a Medical Device (SaMD). The FDA review of prescription digital therapeutics is the same as the process the FDA uses to review medical devices.
Definition and key characteristics of PDTs
PDTs are software-based treatments delivered through mobile devices, designed to address the behavioral and psychological aspects of various health conditions. These digital tools are developed based on scientific evidence and aim to provide therapeutic benefits comparable to traditional medical treatments (Phan et al., 2023).
How PDTs differ from wellness apps and other digital health tools
While wellness apps focus on general health and fitness, PDTs are designed to treat specific medical conditions. PDTs undergo clinical trials, and are subject to stringent regulatory processes to ensure they meet high standards of safety and effectiveness. This regulatory oversight differentiates PDTs from other digital health tools, which may not require such rigorous evaluation.
The PDT regulatory framework
The FDA plays a critical role in the approval of PDTs. These therapeutics must demonstrate clinical efficacy and safety through rigorous trials before receiving FDA clearance. This process ensures that PDTs meet the same standards as traditional pharmaceuticals, providing healthcare providers and patients with confidence in their use (Phan et al., 2023).
The Science Behind Prescription Digital Therapeutics
PDTs are grounded in scientific research and evidence-based practices to ensure their effectiveness in treating various health conditions.
Evidence-based approaches used in PDTs
PDTs incorporate evidence-based approaches to help patients change their behaviors and manage symptoms effectively, such as:
Cognitive Behavioral Therapy (CBT): Used in PDTs for mental health conditions like depression and anxiety, helping patients develop coping strategies.
For instance, CBT-based PDTs can help identify and change negative thought patterns, improving mental health outcomes. A study on a PDT for opioid use disorder found it improved retention in treatment by 76% at 12 weeks compared to treatment as usual (Brezing & Brixner, 2022).
Clinical trials and efficacy studies supporting PDTs
Clinical trials are essential for validating the efficacy of PDTs. These studies assess the therapeutic outcomes of PDTs compared to traditional treatments.
For example, trials have shown PDTs can be effective in managing substance use disorders and chronic insomnia, providing real-world evidence of their clinical benefits (Brezing & Brixner, 2022).
Applications of Prescription Digital Therapeutics
PDTs offer promising solutions across a range of medical conditions, providing tailored interventions for diverse patient needs.
Mental health conditions
PDTs are increasingly used to treat mental health disorders such as depression, anxiety, schizophrenia, and post-traumatic stress disorder (PTSD). In a randomized controlled trial, a PDT for depression reduced symptoms by 45.6% compared to 17.4% with usual treatment (Phan et al., 2023).
For chronic conditions like diabetes and hypertension, PDTs offer personalized management strategies. They enable continuous monitoring and data analysis, facilitating timely adjustments to treatment plans and improving patient outcomes (Phan et al., 2023).
A PDT for type 2 diabetes led to a 1.1% reduction in HbA1c levels after 6 months in a clinical trial (Phan et al., 2023).
Substance use disorders and addiction treatment
PDTs are particularly effective in treating substance use disorders, offering structured programs that support recovery. They provide patients with tools to manage cravings and develop healthier coping mechanisms, contributing to sustained recovery.
A couple of examples:
Research with 1,758 patients using a PDT for substance use disorder showed 64.1% abstinence at 12 months (Brezing & Brixner, 2022).
A PDT for alcohol use disorder resulted in 63% of patients reducing heavy drinking days compared to 32% receiving standard treatment (Rassi-Cruz et al., 2022).
Neurological disorders
Conditions such as ADHD and insomnia can benefit from PDTs, which offer targeted interventions to manage symptoms and improve daily functioning. For instance, PDTs for insomnia often include sleep hygiene education and relaxation techniques to enhance sleep quality.
Benefits of Prescription Digital Therapeutics
PDTs offer numerous advantages that enhance patient care and healthcare delivery.
Improved accessibility to treatment
PDTs make healthcare more accessible by providing treatments that can be delivered remotely via mobile devices. This is particularly beneficial for individuals in underserved areas or those with mobility challenges, ensuring they receive timely care.
Personalized and adaptive interventions
PDTs can be tailored to individual patient needs, offering adaptive interventions that evolve based on real-time data. This personalization enhances treatment effectiveness and patient satisfaction (Phan et al., 2023).
Real-time data collection and analysis
The ability to collect and analyze data in real-time allows healthcare providers to monitor patient progress continuously. PDTs can collect patient data continuously, providing 1440 data points per day compared to 1-4 from traditional in-person visits. This facilitates early detection of issues and enables proactive adjustments to treatment plans, improving overall outcomes (Phan et al., 2023).
Reduced healthcare costs
By providing effective and scalable interventions, PDTs have the potential to reduce healthcare costs. They can decrease the need for in-person visits and hospitalizations, making them a cost-effective alternative to traditional treatments. For example, an economic analysis estimated PDTs could save $2,150 per patient per year for opioid use disorder treatment (Brezing & Brixner, 2022).
Challenges and Limitations of PDTs
Despite their benefits, PDTs face several challenges that must be addressed to maximize their potential.
Federal regulation lags behind software development
Digital therapeutics (DTx) are mobile medical apps that use new tech like artificial intelligence (AI) and virtual reality (VR). They’re always changing, with new versions coming out every few months, which makes them hard to regulate.
A problem with a DTx app could hurt someone’s health, so to keep DTx safe for consumers without stopping progress, software companies need to self-regulate–find ways to reduce risks and follow ethical rules on their own to help patients and build trust with their doctors.
One way to self-regulate is to involve clinicians in app development. Doctors know what patients need and can spot potential problems. But surprisingly, most health apps are made without input from medical experts. A study found only 20% of health apps included input from health professionals during development (Rassi-Cruz et al., 2022).
Data privacy and security concerns
The collection and storage of sensitive health data raise significant privacy and security concerns. Ensuring robust data protection measures is crucial to maintaining patient trust and compliance with regulations (Phan et al., 2023).
Integration with existing healthcare systems
Integrating PDTs into existing healthcare infrastructures can be complex. Seamless integration is necessary to ensure that PDTs complement traditional treatments and fit within the broader healthcare ecosystem.
Patient adherence and engagement
Maintaining patient engagement with PDTs can be challenging.
For example, take mental health apps that use CBT or provide feedback through wearables like smartwatches. While helpful, these apps often aren’t covered by insurance, and patients may pay out-of-pocket. They often give up if they don’t see quick results.
Ensuring that patients adhere to prescribed digital therapies is essential for achieving desired outcomes, requiring strategies to enhance motivation and commitment. Pharmacists can help by encouraging patients to stick with the apps and complete all modules (Pharmacy Times, 2024).
Reimbursement and insurance coverage issues
Securing reimbursement for PDTs remains a hurdle, as insurance companies may be hesitant to cover these relatively new treatments. Establishing clear guidelines and demonstrating cost-effectiveness may help overcome this barrier.
The Future of Prescription Digital Therapeutics
The future of PDTs is promising, with advancements in technology and expanding applications poised to enhance their impact on healthcare.
Emerging trends and technologies in PDTs
Emerging technologies such as artificial intelligence and machine learning are set to revolutionize PDTs. These innovations can enhance personalization and predictive capabilities, improving treatment outcomes and patient experiences.
Potential for combination therapies
Combining PDTs with traditional treatments offers a holistic approach to healthcare. This synergy can enhance therapeutic outcomes by addressing multiple aspects of a patient’s condition, providing comprehensive care (Phan et al., 2023).
Expanding applications in preventive care and wellness
PDTs hold potential for preventive care by identifying and addressing health risks early. Their application in wellness can promote healthier lifestyles and prevent the onset of chronic diseases, contributing to improved public health.
Conclusion
In digital health, PDTs offer promising avenues for improving patient outcomes, increasing access to care, and potentially reducing healthcare costs. While challenges remain, the growing body of evidence supporting PDTs suggests that they will play an increasingly important role in the future of healthcare delivery.
As patients, healthcare providers, and policymakers alike embrace these innovative tools, we can look forward to a more personalized, accessible, and effective approach to managing a wide range of health conditions.
References
Bashran, E. (2024). Prescription Digital Therapeutics: Devices. HealthAffairs. Retrieved from
Brezing, C. A., & Brixner, D. I. (2022). The Rise of Prescription Digital Therapeutics In Behavioral Health. Journal of Behavioral Health; 11(4), 1-10. doi: 10.1007/s12325-022-02320-0
Phan, P., Mitragotri, S., & Zhao, Z. (2023). Digital therapeutics in the clinic. Bioengineering & Translational Medicine; 8(4), e10536. doi:10.1002/btm2.10536.
Rassi-Cruz, M., Valente, F., & Caniza, M. V. (2022). Digital therapeutics and the need for regulation: How to develop products that are innovative, patient-centric and safe. Diabetology & Metabolic Syndrome; 14. doi.org/10.1186/s13098-022-00818-9
Wang, C. Lee, C. & Shin, H. (2023). Digital therapeutics from bench to bedside. npj Digital Medicine; 6(1), 1-10. doi.org/10.1038/s41746-023-00777-z
This guide will walk you through the key factors to consider when selecting RPM devices, so you can make informed decisions that benefit patients and healthcare teams.
RPM devices come in various forms, each with its own strengths and limitations. Let’s explore the main types.
Wearable devices
Wearable devices like smartwatches and patches offer continuous monitoring with minimal disruption to the patient’s daily life. They’re useful for tracking metrics like heart rate, activity levels, and sleep patterns.
Example: The Apple Watch Series can monitor blood oxygen levels, a feature especially useful for patients with respiratory conditions.
Home-based monitoring systems
These devices are designed for periodic measurements at home. They’re typically used for monitoring vital signs like blood pressure, weight, and blood glucose levels.
For certain conditions, implantable devices offer the most comprehensive and continuous monitoring. These are typically used for serious cardiac conditions.
Modern implantable cardioverter-defibrillators (ICDs) can monitor heart rhythm continuously and transmit data to healthcare providers, allowing for early detection of potentially life-threatening arrhythmias (Sahu et al., 2023).
Assessing Patient Needs and Preferences
Choosing the right RPM device isn’t just about the technology—it’s about finding a solution that fits the patient’s lifestyle and capabilities.
Consider the patient’s age and tech-savviness
Not all patients are equally comfortable with technology. When selecting an RPM device, consider the patient’s familiarity with digital devices.
For older adults or those less comfortable with technology, look for devices with simple, straightforward interfaces. Some blood pressure monitors, for instance, require just a single button press to take a reading and automatically sync data to a smartphone app.
Evaluate mobility and dexterity requirements
Some patients may have physical limitations that make certain devices harder to use. Consider devices that are easy to handle and don’t require complex movements.
For example, wrist-worn blood pressure monitors can be easier for patients with arthritis to use compared to traditional upper arm cuffs.
Address privacy and security concerns
Many patients are concerned about the privacy and security of their health data. Look for devices and systems that prioritize data protection.
Ensure that the RPM system you choose complies with HIPAA regulations and uses strong encryption methods to protect patient data during transmission and storage.
Key Features to Look for in RPM Devices
When evaluating RPM devices, it’s crucial to focus on several key features that can make or break your experience.
Data accuracy and reliability
The cornerstone of any effective RPM system is its ability to provide accurate and reliable data. After all, what good is a monitoring device if you can’t trust the information it provides?
Look for devices that have been clinically validated and FDA-approved. These certifications ensure that the device has undergone rigorous testing and meets high standards for accuracy.
Example: The Dexcom G7 continuous glucose monitor has been shown to have a mean absolute relative difference (MARD) of 8.2%, indicating high accuracy in measuring blood glucose levels.
Ease of use for patients
The success of an RPM program depends in part on patient adherence. If a device is too complicated or cumbersome to use, patients are less likely to use it.
Consider devices with intuitive interfaces and clear instructions. For instance, some blood pressure monitors feature large, easy-to-read displays and one-touch operation, making them ideal for older adults or those with limited dexterity.
Battery life and power options
Nothing’s more frustrating than a device that constantly needs charging or battery replacement. Look for devices with long battery life or convenient charging options.
Some wearable devices, like certain fitness trackers, can last up to a week on a single charge. Others, like certain blood glucose monitors, use replaceable batteries that can last for months.
Bluetooth: Ideal for short-range communication with smartphones or tablets.
Wi-Fi: Allows for direct data transmission to the cloud when in range of a network.
Cellular: Offers the most flexibility, allowing data transmission from anywhere with cellular coverage.
For example, some modern pacemakers can transmit data via cellular networks, allowing for continuous monitoring without the need for a separate transmitter.
Compatibility with Existing Healthcare Systems
RPM systems should fit into existing workflows seamlessly. Here’s what to look for.
Integration with electronic health records (EHR)
An RPM system that integrates with your EHR can streamline data management and improve efficiency. Look for systems that offer API integration or direct data transfer to your EHR system.
For instance, some RPM platforms can automatically populate patient data into EHR systems like Epic or Cerner, saving time and reducing the risk of data entry errors.
Data transmission and storage capabilities
Consider how the RPM system handles data transmission and storage. Look for systems that offer:
While the benefits of RPM are clear, cost considerations are important for both healthcare providers and patients.
Initial device costs
The upfront cost of RPM devices can vary widely. Simple devices like blood pressure monitors may cost less than $100, while more advanced systems can run thousands of dollars.
Consider the long-term value rather than just the initial cost. A more expensive device that offers better accuracy and reliability could be more cost-effective in the long run.
Subscriptions and service fees
Many RPM systems involve ongoing fees for data storage, analysis, and support. These costs can add up over time, so it’s important to factor them into your decision.
Some providers offer all-inclusive packages that cover the device, data transmission, and analysis for a fixed monthly fee. This can make budgeting more predictable.
Reimbursement options and insurance coverage
The good news is that many insurance plans cover RPM services, including Medicare. However, coverage can vary depending on the specific device and condition being monitored.
Medicare reimburses for RPM services under CPT codes 99453, 99454, 99457, and 99458. Use these codes to cover device setup, data transmission, and time spent on RPM-related care for your Medicare patients.
Assessing Vendor Support and Reliability
The relationship with your RPM vendor doesn’t end when you purchase the system. Ongoing support is crucial for the success of your RPM program. Here’s what to look for.
Customer service and technical support
Look for vendors that offer comprehensive support, including:
24/7 technical assistance
Multiple support channels (phone, email, chat)
Resources for patient education
Some vendors even offer dedicated account managers to help healthcare providers optimize their RPM programs.
Device maintenance and updates
RPM technology is constantly evolving. Choose a vendor that provides regular software updates and has a clear process for hardware maintenance or replacement.
For example, some vendors offer automatic over-the-air updates for their devices, ensuring they’re always running the latest software.
Training for healthcare providers and patients
The success of an RPM program often hinges on proper training. Look for vendors that offer comprehensive training programs for both healthcare providers and patients.
This may include:
In-person or virtual training sessions
Online resources and tutorials
Ongoing education about new features or best practices
Some vendors even offer patient onboarding services to help get your RPM program up and running smoothly.
Conclusion
Choosing the right RPM system or device involves careful consideration of various factors, from technical specifications to patient needs and regulatory compliance. By focusing on these key areas, you can select an RPM solution that enhances patient care, improves outcomes, and integrates seamlessly with your existing healthcare routine.
The goal is to find devices that monitor health effectively and integrate seamlessly into patients’ lives and your healthcare workflows. Take the time to thoroughly evaluate your options, and don’t hesitate to ask vendors for demonstrations or trial periods before making a decision.
With the right RPM system in place, you can provide more personalized care to your patients, no matter where they are. Stay informed about the latest options so you can make the best choices for your patients and practice.
Telehealth has dramatically changed how primary care is delivered, especially since the COVID-19 pandemic. Analyses of commercial claims in 2022 show that telehealth services were mostly rendered by primary care, psychiatry and psychology clinicians, as well as social workers. This shift expands healthcare access. It’s also introduced new challenges and opportunities for providers and patients that use telehealth in primary care.
In this article, we’ll explore the various facets of telehealth in primary care, its benefits, challenges, and best practices for implementation.
Let’s look at some advantages of using telehealth in a primary care practice.
Cost-effectiveness
Telehealth can be cost-effective for both healthcare providers and patients. It reduces overhead costs for healthcare facilities and lowers patient expenses related to transportation and time off work.
Reduced Overhead: Healthcare providers can save on costs related to office space, utilities, and administrative staff.
Lower Patient Costs: Patients save money on travel expenses and can avoid taking unpaid time off work for appointments.
Efficient Resource Use: Telehealth can help optimize the use of healthcare resources by reducing the need for in-person visits for minor issues.
Increased access to care
Telehealth has made healthcare more accessible, especially for those in remote or underserved areas. Patients no longer need to travel long distances to see a doctor. This is particularly beneficial for people with mobility issues or those without reliable transportation.
Remote Access: Telehealth allows patients in rural areas to access specialists and primary care providers without the need for travel.
Convenience: Patients can schedule appointments at times that work best for them, reducing the need to take time off work or arrange childcare.
Reduced Costs: Telehealth can save patients money on travel expenses and lost wages from taking time off work.
Improved patient engagement
Telehealth makes it easier for patients to stay in touch with their healthcare providers. This can lead to better patient adherence to treatment plans, and improved health outcomes (Hatef et al., 2024). A few specific telehealth offerings that help improve patient engagement are:
Continuous Monitoring: Telehealth allows for continuous monitoring of chronic conditions, allowing for prompt interventions.
Follow-Ups: Virtual follow-up appointments can ensure that patients are following their treatment plans and making necessary lifestyle changes.
Patient Education: Telehealth platforms can provide educational resources to help patients understand their conditions and treatments better.
TCM is well-suited for activities like check-ins, refills, reminders, and care coordination, but in-person appointments are often required for complex needs and initial assessments. Providers noted that video visits can help bridge the gap between in-person and phone visits, but the lack of face-to-face interaction can obscure visual health cues (Delahunty-Pike et al., 2023).
Phone visit attendance vs. video visits
A study published in the Journal of General Internal Medicine compared non-attendance rates for telehealth and in-person primary care visits at a large urban healthcare system (Chen et al., 2022). The researchers found that telephone visits had similar or lower non-attendance rates compared to in-person visits, but video visits had higher non-attendance rates. This suggests that phone visits may be easier for patients than video visits.
They also identified certain demographic groups that had consistently higher or lower non-attendance rates across visit modalities. Patients who were White, male, and had public insurance or no insurance, and generally had higher non-attendance rates. In contrast, patients who were Asian or had more comorbidities had lower non-attendance rates.
These findings highlight the importance of considering patient preferences, digital access, and demographic factors when implementing telehealth services.
Telehealth Challenges and Limitations
While telehealth has many advantages in healthcare, it also presents several challenges that healthcare providers and patients must navigate.
Licensing Issues: Providers may need to be licensed in the state where the patient is located, which can complicate the delivery of telehealth services.
Quality of care concerns
Some healthcare providers and patients are concerned about the quality of care delivered via telehealth. While telehealth can be effective for many types of care, it may not be suitable for all situations.
Physical Examinations: Certain conditions require a physical examination, which can be difficult to perform remotely.
Technical Support: Offering technical support to both patients and providers can help overcome some of the technical barriers to telehealth.
Training and support
Proper training and support are essential for both healthcare providers and patients to use telehealth effectively.
Provider Training: Healthcare providers should receive comprehensive training on how to use telehealth platforms and deliver care virtually.
Patient Support: Providing patients with resources and support can help them navigate telehealth platforms and feel more comfortable with virtual visits.
Ongoing Education: Continuous education for providers and patients can help keep them updated on best practices and new developments in telehealth.
Patient-centered approaches
Health providers should customize telehealth options to meet the individual needs of their patients and ensure the best possible outcomes. Some ideas:
Managing Cost Expectations: It’s important to manage patient expectations around insurance coverage and reimbursement for telehealth, as uncertainty can deter long-term investment (Khairat et al., 2023).
Patient Education: Patients, especially older adults, may struggle to remember information from telehealth visits and miss printed summaries. Sending visit summaries via a patient portal and referencing educational videos can mitigate these issues (Khairat et al., 2023).
Feedback Mechanisms: Incorporating patient feedback can help improve telehealth services and ensure they meet patient needs.
Telehealth in primary care has shown mixed effects on healthcare providers (Cannedy et al., 2023).
In a report for the Veterans Health Administration (VA), some primary care team members reported that telehealth increased their job flexibility and reduced burnout, with shorter patient visits.
However, others experience anxiety and reduced job satisfaction due to challenges in remote patient management, workflow changes, and technology issues.
To improve telehealth adoption and satisfaction among healthcare professionals, effective education, quality technology, and better workflow integration are crucial. Overall, the impact of telehealth on provider well-being and job satisfaction remains complex and varied.
Future of Telehealth in Primary Care
As telehealth continues to change and improve, we must explore its potential developments and trends.
Hybrid Models: Combining telehealth with traditional in-person visits can provide a more comprehensive approach to care.
Preventive Care: Telehealth can also be used for preventive care, such as routine screenings and health education.
Chronic Disease Management: Telehealth can be particularly effective for managing chronic conditions, allowing for regular monitoring and timely interventions.
A study of patients with chronic conditions found that physical exams make up a small percentage of in-person chronic condition management consultations. Discussions are critical for clinicians when they update treatment plans, as history-taking is more important than physical exams for diagnoses (Ward et al., 2023).
Advancements in Telehealth Technology
Emerging technologies are likely to play a significant role in the future of telehealth.
Remote Monitoring Devices: Wearable devices and remote monitoring tools can provide real-time data to healthcare providers, improving patient outcomes.
Virtual Reality: Virtual reality (VR) technology can be used in patient consultations and education, providing an immersive experience.
Policy and Regulation Evolution
As telehealth continues to grow, policies and regulations will need to evolve to support its use.
Standardization: Efforts to standardize telehealth practices and reimbursement policies can help ensure consistent and equitable access to telehealth services.
Licensing Reforms: Reforms to licensing requirements can make it easier for providers to offer telehealth services across state lines.
Conclusion
Telehealth in primary care is here to stay. Its suitability depends on several factors like patient preferences, digital access, health conditions, and provider needs. While it offers flexibility, disparities in internet access and workflow disruptions can undermine its advantages.
To improve access and engagement in care, health providers must address barriers and design telehealth services that better meet the needs of diverse patient populations (i.e., in demographics, technical skill, and access).
The integration of telehealth with traditional care models will likely continue to evolve, making healthcare more accessible and efficient. By adopting best practices and leveraging technological advancements, healthcare providers can improve the telehealth experience for their patients, and increase engagement.
Explore the possibilities of telehealth in your practice today and join the movement towards a more connected and patient-centered healthcare system.
References
Cannedy, S., Leung, L., Wyte-Lake, T., Balut, M. D. Dobalian, A., Heyworth, L. Paige, N. M. & Der-Martirosian, C. (2023). Primary Care Team Perspectives on the Suitability of Telehealth Modality (Phone vs Video) at the Veterans Health Administration. Journal of Primary Care & Community Health. 14(1-8). doi:10.1177/21501319231172897
Chen, K., Zhang, C., Gurley, A., Akkem, S., & Jackson, H. (2023). Appointment Non-attendance for Telehealth Versus In-Person Primary Care Visits at a Large Public Healthcare System. Journal of General Internal Medicine; 38, 922–928. doi.org/10.1007/s11606-022-07814-9
Delahunty-Pike, A., Lambert, M., Schwarz, C., Howse, D., Bisson, M., Aubrey-Bassler, K. Burge, F., Chouinard, M., Doucet, S., Luke, A., Macdonald, M., Zed, J., Taylor, J, & Hudon, C. (2023). Stakeholders’ perceptions of a nurse-led telehealth case management intervention in primary care for patients with complex care needs: a qualitative descriptive study. BMJ Open; 13:e073679. doi:10.1136/bmjopen-2023-073679
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Home health monitoring wearables to track blood pressure, heart rate and sleep are popular. A 2022 AnalyticsIQ study of 8,000 Americans showed that we’ve doubled our use of wearable health devices between 2020 and 2021. Almost half of the respondents used at least one type of wearable tech, and Black, Latinx, male, and Gen X respondents used it the most.
This surge in popularity is no surprise, as home health monitoring empowers people to take control of their well-being from the comfort of their own homes.
In this guide, we’ll walk you through the essentials of setting up a home health monitoring system.
Home health monitoring uses technology to track and manage health conditions at home or on the go.
Home health monitoring systems let you monitor various health metrics and share the data with healthcare providers remotely. It includes connected health devices and apps to collect, analyze, and transmit health data, facilitating continuous health management without frequent in-office visits (Story, 2010).
Source: ScienceDirect.com, Ahmed & Kannan, 2022.
Key benefits of monitoring health at home
Home health monitoring offers numerous advantages:
Increased Health Awareness: People become more aware of their health status, making informed decisions about diet, lifestyle, and treatment options.
Reduced Physical Consultations: Minimizes the need for in-person visits, which can be beneficial for people with mobility issues or those living in remote areas.
Real-Time Intervention: Allows for prompt medical interventions based on real-time data, to prevent potential complications.
Cost Savings: Reduces healthcare costs by decreasing hospital admissions and emergency room visits.
Improved Chronic Disease Management: Enhances the management of chronic conditions through continuous monitoring and timely adjustments to treatment plans.
Trackable health metrics
Home health monitoring can track a wide range of health metrics, including:
Vital Signs: Heart rate, blood pressure, and body temperature.
Biometric Data: Blood glucose levels, blood oxygen saturation (SpO2), and body composition.
Activity Levels: Steps taken, calories burned, and sleep patterns.
Symptoms: Tracking symptoms related to chronic conditions or acute illnesses.
Medical and tech devices for home health monitoring
Several technologies and devices are available for home health monitoring (Dusun, 2024):
Smart Scales: Measure weight and body composition.
Special monitors for dementia and Parkinson’s disease
Breathing apparatuses
Fetal monitors
Let’s review each of the less complex medical devices in turn.
Essential Devices for Home Health Monitoring
Smart scales for weight and body composition
A study in England showed that smart scale users who weighed themselves often were more likely to lose weight, and weigh themselves after recent weight loss (Sperrin et al., 2016).
Smart scales go beyond measuring weight; they can also analyze body composition, including body fat percentage, muscle mass, and bone density. These scales connect to health apps, allowing users to track their progress over time.
Before measuring your body composition:
Don’t drink alcohol for 2 days before measuring.
Avoid exercise, coffee, chocolate, or other diuretics (drinks that make you pee a lot) for 12 hours.
Don’t eat or drink anything for 4 hours before.
Don’t measure if you’re sick with a fever or diarrhea.
Use the bathroom within 30 minutes of measuring.
How to use a smart scale
Mondal & Mondal (2021) recommend the following steps to measure your body composition:
Enter your age, sex, and height into the device.
Stand in the right position to ensure you’re touching the electrodes properly.
If your hands and feet are very dry, use a damp cloth to moisten them.
Stand still during the measurement.
These devices may show body fat as a percentage, but don’t rely on just one measurement. Take three in a row, find the average (add the results, then divide by three), and write it down in a health log or app.
Blood pressure monitors
Blood pressure monitors are essential for people with hypertension or heart conditions. These devices provide accurate readings of systolic and diastolic blood pressure to manage cardiovascular health.
Before taking your blood pressure:
Don’t measure your blood pressure until at least 30 minutes after having tea, coffee, energy drinks, cigarettes, or exercising.
Remove tight clothes and use the bathroom.
How to use a blood pressure monitor
Mondal & Mondal (2021) recommend the following steps to take your blood pressure:
Sit in a chair with back support, and legs uncrossed with feet flat on the floor. Rest your arm on a table at heart level.
Put the cuff on their bare arm and start measuring. Don’t move or talk during the measurement.
Take two readings one minute apart, and take the average of them (add the results, then divide by two). For better accuracy, you can do three readings, but it’s optional.
Write down the final number in a health log or app to track any changes.
Glucose meters for diabetes management
Glucose meters, or glucometers, are crucial for diabetes management, which helps people monitor their blood sugar levels regularly. Some advanced models can sync with smartphones and health apps for easy tracking and data sharing with healthcare providers.
How to use a glucose meter
Mondal & Mondal (2021) recommend the following steps to measure your blood sugar:
Check if that the test strips have not expired.
Wash and dry your hands.
Take a test strip and close the container. Use a new lancet each time.
Put the lancet in the right spot on the device and set how deep it will prick based on what works for you or how thick your skin is.
After loading the device, prick your ring or middle finger. You might need to gently squeeze your finger for enough blood.
Once the blood touches the strip, the meter will take a moment to complete the measurement. The result will show up on the device or your phone.
Throw away the used lancet in a special container for sharp objects and the strip in a biohazard bin. You might need to press your finger with cotton to stop bleeding. You can clean the lancet tip with an alcohol wipe. Write down your blood sugar reading right away in a health log.
Pulse oximeters for oxygen saturation levels
Pulse oximeters measure the oxygen saturation level in the blood, which is vital for people with respiratory conditions like chronic obstructive pulmonary disease (COPD) or COVID-19. These devices are easy to use and provide quick, accurate readings.
Before you take a measurement with a pulse oximeter, remove any nail polish from the finger you’re going to use.
How to use a pulse oximeter
Mondal & Mondal (2021) recommend the following steps to measure your oxygen level:
Wash and dry your hands.
Put the device on your finger so it’s not too loose or tight. Don’t use a finger with a tattoo or henna on it.
Make sure your finger covers the lights and sensor properly.
Avoid bright light, which can cause errors. If you can’t, cover the device with a cloth.
Start the device, and keep your finger still during measurement.
Every few days of use, clean the device with an alcohol wipe to ensure accurate readings.
Wearable fitness trackers and smartwatches
Wearable fitness trackers and smartwatches monitor various health metrics, including heart rate, steps taken, calories burned, and sleep patterns. They are popular for their convenience and integration with health and fitness apps.
Note that sometimes, these devices make errors. These errors can happen because the sensors in these devices aren’t perfect at counting or estimating. For example, fitness trackers worn on the wrist may count fewer steps than you actually take if you walk slowly (Hicks et al., 2019).
ECG monitors
Irregular heartbeats, known as heart rate arrhythmia, are a major sign of common heart diseases and can be very dangerous. Because these irregularities can happen suddenly, are hard to notice, and change quickly, it’s important to keep track of heart rate changes in real-time to spot and prevent problems early (Zhang & Yang, 2023).
A home electrocardiogram (ECG) monitor can track your heart rate. Note that while wearable ECG monitors can detect heart rhythm issues, but may miss some due to intermittent recording. They’re usually expensive and not covered by insurance.
Medical-grade monitors are more accurate, using chest sensors for continuous recording. Personal devices use wrist or finger sensors and may require manual activation, making them less reliable for serious conditions (Samaan, 2022).
Before measuring your heartbeat:
Move electronic devices, metal, and magnets away from the ECG device.
Sit quietly for 5 minutes.
How to use
Mondal & Mondal (2021) recommend the following steps to analyze your heartbeat:
If your hands are dry, use a damp cloth to moisten them.
Follow the instructions to place the electrodes correctly.
Start the device. Don’t move or talk during the measurement.
Have a doctor look at the results afterward.
Medication adherence trackers
Taking your medication as prescribed is a critical part of your overall health and wellness. To help you remember when to take your meds, use one or more medication adherence monitoring technologies like:
Medication reminder apps
Electronic pill boxes, bags, or bottles
Ingestible sensors
Blister packs
While these devices offer real-time data and improve adherence monitoring, they face challenges like accuracy issues and expensive implementation. Most rely on proxy measures like device opening events, limiting data precision, and integration with clinical systems is a challenge. (Mason et al., 2022).
Next, we’ll learn how to pick the right health monitoring device for your specific needs.
Choosing the Right Monitoring Devices
Factors to consider when selecting devices
When choosing home health monitoring devices, consider the following factors:
Ease of Use: Devices should be user-friendly, especially for those with limited technical skills.
Accuracy and Reliability: Look for devices with proven accuracy and reliability, supported by clinical validation.
Compatibility: Ensure devices are compatible with your smartphone, tablet, or other health platforms.
Battery Life: Consider devices with long battery life to avoid frequent recharging.
Customer Support: Opt for brands that offer robust customer support and warranty services.
Compatibility with smartphones and other tech
Many home health monitoring devices are designed to sync with smartphones and other tech platforms. This integration allows for seamless data transfer, real-time monitoring, and easy access to health metrics through dedicated apps.
Accuracy and reliability of different brands
To ensure you choose the right device, check that the device is approved by the proper authority such as the FDA or ISO (Mondal & Mondal, 2021).
Research and reviews can also help determine the accuracy and reliability of different brands. Look for devices with positive feedback from users and healthcare professionals, and check for any clinical validation or certifications.
Once you get your medical device, it’s important to use them properly, and calibrate them at the intervals the manufacturer recommends to maintain its accuracy (Mondal & Mondal, 2021).
Budget considerations and cost-effectiveness
While some advanced devices can be expensive, there are cost-effective options available that still offer reliable performance. Consider your budget and prioritize devices that provide the best value for money without compromising on essential features.
Once you’ve chosen your devices, it’s vital to address the important aspects of data protection and privacy.
Privacy and Security Considerations
Home health monitoring and remote patient monitoring (RPM) are part of telehealth. Telehealth provides convenience, but also comes with security risks and issues (Houser et al., 2023):
Environmental issues: Some people don’t have a private space at home to discuss their health.
Let’s look at a few best practices to protect and secure your personal health information.
Protect your health data from breaches
Health data is sensitive and must be protected from breaches. Some tips:
Use strong passwords for your health apps and devices.
Turn on two-factor authentication in your apps.
Use email, chat, or messages through the patient portal. This is especially useful when a private location is temporarily unavailable. If the situation isn’t temporary, ask your health provider for suggestions (Houser et al., 2023).
Regularly update your software to protect against vulnerabilities.
Understand data ownership and sharing policies
Some apps may share data with third parties for research or marketing purposes. Read the privacy policies of your health apps and devices to understand who owns your data and they share it. Opt for apps that prioritize user privacy and offer clear data ownership policies.
Secure your home network for health devices
Some tips to secure your home network include:
Use a strong Wi-Fi password and enabling network encryption.
Check the URL address bar of your browser before you enter your personal information on a website. A secure website will show a lock icon in the address bar, and look for https:// at the beginning of the URL (as some do not include the “s”).
Install and use anti-virus software on your devices.
Avoid using public Wi-Fi networks for health monitoring, as they are more susceptible to breaches.
Check compliance with health data regulations
Health Insurance Portability and Accountability Act (HIPAA) is a regulation in the U.S. that protects the privacy and security of people’s personal health information. Check whether your health monitoring devices and apps are HIPAA-compliant before you use them, or the similar standards in your region if you’re not in the U.S. (Gerke et al., 2020).
Now that you know how to secure your data, it’s time to create an effective monitoring environment in your home.
Setting Up Your Home Health Monitoring System
Create a dedicated space for health monitoring
Designate a specific area in your home for health monitoring. This space should be quiet, well-lit, and free from distractions to ensure accurate measurements. Keep all your monitoring devices and accessories organized and easily accessible.
Connect devices to your home network
Most home health monitoring devices use Wi-Fi or Bluetooth to connect to your home network. Follow the manufacturer’s instructions to pair each device with your smartphone or tablet. Ensure your home network is secure to protect your health data.
Sync devices with health apps and platforms
Download the necessary health apps for your devices and create accounts if required. Synchronize your devices with these apps to enable data transfer and real-time monitoring. Popular health platforms include Apple Health, Google Fit, and dedicated apps from device manufacturers.
Set a daily routine for regular measurements
Consistency is key to effective home health monitoring. Establish a routine for taking measurements, such as checking your blood pressure every morning or measuring your blood glucose levels before meals. Set reminders on your smartphone to help you stay on track.
With your system set up, let’s see how to make sense of the data you’re collecting.
Interpreting and Using Health Data
Learn about health metrics
Get familiar with the health metrics your devices track, and understand what they mean. For example, know the normal ranges for blood pressure, blood glucose, and oxygen saturation levels. Health apps often provide explanations and visualizations to help you interpret the data (Chan et al., 2022).
Recognize normal ranges and potential red flags
Knowing the normal ranges for your health metrics allows you to identify potential red flags. For instance, a consistently high blood pressure reading may indicate hypertension, while low oxygen saturation levels could signal respiratory issues (Chan et al., 2022). Consult your healthcare provider if you notice any abnormal readings.
Set health goals and track progress
Use the data from your monitoring devices to set health goals, such as achieving a target weight or maintaining stable blood glucose levels. Track your progress over time and adjust your goals as needed. Health apps often offer goal-setting features and progress-tracking tools.
Share data with healthcare providers securely
Many health apps allow you to share your data with healthcare providers securely. This can be done through app integrations, email, or cloud storage platforms. Sharing your data helps your healthcare provider make informed decisions about your treatment plan and monitor your progress remotely.
Maximizing the Benefits of Home Health Monitoring
To get the most out of your home health monitoring system, consider these strategies for integrating it into your daily life.
Integrate monitoring in your daily routine
Include health monitoring into your daily routine to make it a habit. For example, you can check your blood pressure while having your morning coffee or track your steps during your evening walk. Consistency ensures accurate data and better health management (Kariuki, n.d.).
Make lifestyle improvements
Use the insights from your health data to make positive lifestyle changes. For instance, if your fitness tracker shows low activity levels, you can set a goal to increase your daily steps. If your blood glucose levels are high, you can adjust your diet and exercise routine accordingly (Kariuki, n.d.).
Combine monitoring with telehealth services
Telehealth services complement home health monitoring by providing remote consultations with healthcare providers. Share your health data during these virtual visits to receive personalized advice and treatment plans. Telehealth can be especially beneficial for managing chronic conditions and reducing the need for in-person visits.
Involve your family in health-tracking
Involving family members in your health monitoring can provide additional support and motivation. Share your health goals and progress with them, and encourage them to participate in health-tracking activities. This can create a supportive environment and improve overall health outcomes.
Conclusion
Setting up a home health monitoring system is a proactive step to take charge of your well-being. Once you choose the right devices, set a consistent monitoring routine, and learn how to interpret your health data, you can gain valuable insights into your body’s needs and trends.
Remember, home health monitoring is no substitute for professional medical advice. Use your newfound knowledge to have more informed discussions with your healthcare provider, ask questions, and make proactive decisions about your health. With the right approach, home health monitoring can lead to better health outcomes and an improved quality of life.
Which health monitors and wearables do you use, and how do they help you?
References
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Gerke, S., Shachar, C., Chai, P. R., & Cohen, I. G. (2020). Regulatory, safety, and privacy concerns of home monitoring technologies during COVID-19. Nature Medicine, 26(8), 1176. doi.org/10.1038/s41591-020-0994-1
Hicks, J. L., Althoff, T., Sosic, R., Kuhar, P., Bostjancic, B., King, A. C., Leskovec, J., & Delp, S. L. (2019). Best practices for analyzing large-scale health data from wearables and smartphone apps. Npj Digital Medicine; 2(1), 1-12. doi.org/10.1038/s41746-019-0121-1
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