Enhancing Research with Wearables in Clinical Trials

Enhancing Research with Wearables in Clinical Trials

AI Health Tech Med Tech

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.

Contents

Wearables in Medical Research

What are wearables?

Wearables are small, smart devices like sensors that, combined with apps, collect health data. These devices can track everything from your heart rate to how well you sleep. They’re like having a mini-lab on your wrist or body. 

Wearables in clinical trials refers to all types of medical tech used in medical research.

Types of wearable devices used in clinical trials

Black woman gold top showing phone with glucose meter on arm

There’s a whole range of wearables being used in medical research:

The popularity of wearables in 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). 

Wearable devices make collecting health data easier for medical researchers. They allow for real-time analysis of large data sets and help identify health trends, which brings ease and precision to clinical trials and medical studies.

Benefits of Using Wearables in Clinical Trials

Why are researchers so excited about wearables? Let’s break it down.

Real-time data collection and monitoring

Monitoring dashboard on a desk

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.

Improved patient engagement and compliance

People are more likely to stick with a study when they’re using familiar devices. RPM systems often include medication reminders and tracking features, which can significantly improve adherence rates

Enhanced accuracy and objectivity of data

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.

Continuous vital sign monitoring

Wearables can track heart rate, blood pressure, and even oxygen levels around the clock. This is especially useful in studies of heart conditions or respiratory diseases.

Activity and sleep tracking

Older woman asleep wearing smartwatch next to cell phone

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.

Medication adherence tracking

Timed pill box

Some smart pill bottles can remind patients to take their medication and record when they do. This helps clinicians know if patients are following the treatment plan.

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

Hacker in a red hoodie

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.

Regulatory hurdles and FDA approval processes

Getting new devices approved for use in clinical trials can be a long and complex process. The FDA has strict rules about what devices can be used and how data can be collected.

Integration with existing clinical trial systems

Many research centers have established systems for collecting and analyzing data. Integrating wearable data into these systems can be tricky and time-consuming, but can be overcome.

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.

Monitor attached to back of a woman's left shoulder

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

Both patients and research staff need to know how to use the wearables correctly. Good training can improve data quality and reduce errors.

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.

What’s next for wearables in clinical trials? Let’s take a peek.

Smart watch illustration in blue and red

AI and machine learning integration for data analysis

As the amount of data grows, artificial intelligence (AI) and Internet of Things (IoT) will play a bigger role in making sense of it all. AI can help spot patterns and trends that humans might miss.

Multi-modal sensors

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

By collecting detailed, individual health data, wearables help tailor treatments to each patient’s unique needs.

Conclusion

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/

Williams, K. (2023). The Future of Clinical Trials: Embracing Wearables and Beyond. Datacubed Health. Retrieved from https://www.datacubed.com/the-future-of-clinical-trials-embracing-wearables-and-beyond-2/

Streamlined Medical Practice with Ambient Clinical Intelligence

Streamlined Medical Practice with Ambient Clinical Intelligence

AI Health Tech Med Tech

Since the onset of the pandemic, more healthcare workers and clinicians have experienced burnout, leading to dissatisfaction among both patients and clinicians. Overworked clinicians often make errors in their documentation, and their lack of time and stressed demeanor can erode the trust between physicians and patients. Dissatisfied and neglected patients are less likely to engage with their care, adhere to care plans, and follow preventive healthcare advice, increasing the likelihood of adverse outcomes (DeepScribe, 2023).

In Medscape’s 2021 physician survey, 42% of physicians reported feeling burned out, citing “too many bureaucratic tasks” and “spending too many hours at work” as the main causes. Providers often spend hours documenting patient care, and the administrative burden often stretches into their own time. The Association of American Medical Colleges projects a shortfall of nearly 122,000 physicians in the US by 2032 (Harper, 2022).

Ambient Clinical Intelligence (ACI) is a technology that can help alleviate the burden of medical documentation for clinicians, among many other benefits we’ll explore in this article. But first, let’s get a better understanding of ACI.

Contents

What is Ambient Clinical Intelligence?

Robot sitting in a patient room

ACI brings together several technologies that work together to improve healthcare:

  • Ambient intelligence
  • Artificial intelligence (AI)
  • Data analytics
  • Internet of Things (IoT)
  • Natural Language Processing (NLP)

ACI in healthcare includes IoT-based tools such as temperature and humidity sensors, blood pressure monitors, and other devices that autonomously collect data and continuously update doctors on the vital statistics of critical patients (Joshi, 2022).

“Imagine a hospital where every room, every corridor, every piece of equipment is interconnected, constantly gathering data, analyzing it, and providing insights,” says Jon Morgan, CEO and Editor-in-Chief of VentureSmarter. “It means doctors and nurses have access to a wealth of information right at their fingertips, allowing for quicker and more accurate diagnoses. This can significantly improve patient outcomes because decisions are based on a comprehensive analysis of real-time data rather than just a snapshot in time.” 

Let’s explore how ACI can make healthcare tasks more efficient in both healthcare settings and patients’ homes. 

infographic with statistics on different ACI use cases and RPM

ACI Use Cases for Clinical Spaces

ACI can improve the quality of health services by making many processes more efficient, such as:

  • Transcribing medical notes
  • Creating reports
  • Patient monitoring

This section describes some of ACI’s biggest benefits in healthcare settings.

Clinical documentation during patient care

Doctors looking at paperwork together

ACI technology can help alleviate the burden of medical documentation for clinicians, allowing them to give their full attention to patients during visits while ACI creates accurate clinical notes directly in the electronic health record (EHR) for review (Augnito, 2023). (This a concept included in the fancier term, “AI-powered medical documentation automation.”) ACI can also spot indicators of depression, anxiety, and social determinants of health (SDoH) during patient-physician conversations (Harper, 2022).

In one study, a deep learning (DL) model trained on 14,000 hours of outpatient audio from 90,000 conversations between patients and physicians. The transcription accuracy of the DL version was 80%, compared to 76% accuracy by medical scribes (Haque et al., 2020). 

In another example, a medical provider found that microphones attached to eyeglasses reduced documentation time from 2 hours to just 15 minutes. This huge time savings doubled the time spent with patients (Haque et al., 2020).

By automating routine tasks and documentation, ACI allows healthcare providers to spend more time focusing on direct patient care, leading to patient satisfaction.

Patient satisfaction

A nurse speaking to patient

The automation of ACI can help strengthen the patient-physician relationship and increase patient satisfaction, engagement, and retention. 

“Using systems that can automatically monitor patients’ vital signs, track medication administration, and even predict potential complications,” Morgan says.  “Healthcare professionals can focus more on direct patient care rather than spending time on administrative tasks. This improves the overall quality of care while also reducing the burden on healthcare workers in today’s overstretched healthcare systems.”

Tests and reports

With ACI tools, hospitals can conduct tests on patients and monitor them autonomously with wireless sensors and wearable devices

For example, an ambient intelligence sensor monitors a patient’s health by dynamically tracking their vitals. First, it collects and assesses vitals, body fat, blood sugar, cholesterol levels, and other details. Then it can create a report listing potential illnesses and recommendations on diagnoses, medical coding, diet, medications, and lifestyle (Joshi, 2022).

By enhancing data interoperability, ACI eliminates the need for redundant paperwork and testing. ACI can streamline care coordination by compiling data from various sources into consolidated dashboards, providing clinicians with a holistic view of each patient. Reviewing these dashboards can help them better understand their patients’ clinical history, medications, test results, and more (Augnito, 2023). 

Tracking infectious disease

IoT, thermal vision cameras, and AI can check infected zones, such as surfaces where infectious viruses are found, and ensure they are cleaned and decontaminated. Thermal vision cameras are also useful for monitoring crowded areas and tracking individuals who may carry a contagious disease (Joshi, 2022).

Surgical training

In the operating room (OR), ambient cameras can be used for endoscopic videos to improve surgical training. Ambient intelligence can also account for surgical objects in the OR, including those that could be left inside a patient during a procedure, to mitigate staff errors (Haque et al., 2020).

Continuous patient monitoring in the ICU

In one study, ambient sensors in hospital intensive care units (ICUs) monitored the movements of patients, clinicians, and visitors with over 85% accuracy.

In another study, sensors installed above hand sanitizer dispensers across a hospital unit were 75% accurate in measuring handwashing compliance within one hour, while a human observer was only 63% accurate (Haque et al., 2020).

Patient in ICU with monitor in foreground

Observing patients post-surgery

Ambient intelligence in recovery rooms post-op can continuously observe recovery-related behaviors, giving providers insight into movement and other activities. This can reduce recovery time and improve post-surgical outcomes (Joshi, 2022).

While ACI offers numerous benefits in clinical spaces, its potential extends beyond hospital walls.

ACI for Aging in Place: Enhancing Independent Living

By 2050, the world’s population aged 65 years or older will increase from 700 million to 1.5 billion (Haque et al., 2020). As people live longer, their independent living, chronic disease management, physical rehabilitation, and mental health become paramount. 

Promoting autonomy for patients with remote patient monitoring (RPM)

Activities of daily living (ADLs), such as bathing, dressing, and eating, are critical to the well-being and independence of aging adults. Aging and elderly patients living at home are at an increased risk for falls, accidents, and emergencies. Impairment in performing ADLs is associated with a twofold increased risk of falling, and up to a fivefold increase in the one-year mortality rate (Haque et al., 2020).

RPM through ACI can analyze their daily activities to detect significant changes that may need a closer look. It can also help identify changes in vital signs, movement patterns, sleep rhythms, behaviors, and emerging symptoms that may signal a decline in a patient’s quality of life. Ambient-assisted living using the ACI-RPM combo can also monitor patients for early signs of dementia and Alzheimer’s. 

“The constant monitoring and analysis of patient data in real-time can help in early detection of health issues,” says Collen Clark, Medical Malpractice Lawyer and Founder of Schmidt & Clark LLP. “This allows for quicker interventions and personalized treatment plans, while reducing the risk of medical errors, which can have legal implications related to negligence or malpractice.” 

Any concerning findings from RPM automatically trigger alerts to healthcare providers, allowing them to intervene early with quick, proactive outreach to patients in need. This can prevent avoidable ER visits, hospitalizations, and health emergencies (Augnito, 2023).

Wearable sensors for monitoring and fall detection in seniors

Two doctors chatting in a hallway

Wearable devices such as accelerometers or electrocardiogram sensors can track not only ADLs but also heart rate, glucose level, and respiration rate. They can even remind patients to take their medications (Haque et al., 2020), and detect falls.

As wearable devices and IoT ecosystems in healthcare continue to expand, integrating them with ACI systems can provide continuous personalized monitoring and truly ambient intelligent care. 

Patients can get proactive alerts about potential health issues before they become critical, and get customized recommendations. Streamlining the flow of data from personal sources like fitness trackers to electronic health records via ACI can massively enrich patient profiles for highly tailored care (Augnito, 2023).

Ambient sensors

In one study, researchers installed a depth and thermal sensor inside the bedroom of an older individual and observed 1,690 activities during one month, including 231 instances of caregiver assistance. A convolutional neural network was 86% accurate at detecting assistance. In a different study, researchers collected ten days of video from six individuals in an elderly home and achieved similar results (Haque et al., 2020).

Although the data from visual sensors are promising, they raise privacy concerns in some places like bathrooms, where grooming, bathing and toileting activities occur. To counter this, researchers also explored acoustic and radar sensors. One study used microphones to detect showering and toileting activities with accuracy rates of 93% and 91%, respectively (Haque et al., 2020). 

ACI has tremendous potential. However, it’s important to consider some challenges and limitations.

ACI Caveats and Considerations 

Flatlay of small medical items

The use cases and benefits of ACI are remarkable, but as with any technology, there are still considerations to gain its maximum benefit in the larger healthcare ecosystem.

Bias

ACI systems are dependent on the quality of data used to train algorithms. If that data reflects societal biases, the AI could make flawed judgments and recommendations. There’s also the risk of over-reliance on AI diagnostics versus human expertise. Careful oversight is required to audit algorithms and ensure AI transparency in clinical decision-making (Augnito, 2023).

Data privacy and security

There is a heightened risk of unauthorized access or breaches with ACI. Patients have a right to understand how their data is used with ACI tools during consultations and treatment. Health providers should disclose this information and request patient consent, which is optional. 

“With the continuous stream of patient data being collected, stored, and analyzed by ACI systems, there’s a heightened risk of unauthorized access or breaches,” Clark says. “I would advise hospitals to invest in robust data protection measures and ensure compliance with relevant regulations such as HIPAA. It’s essential to strike a balance between leveraging the benefits of ACI and safeguarding patient privacy to avoid legal repercussions.”

Computational methods to protect privacy include (Haque et al., 2020):

  • differential privacy (adds noise to the collected data)
  • face blurring
  • dimensionality reduction (pixelated images)
  • body masking (replaces people’s images with faceless avatars)
  • federated learning (gradient updates)
  • homomorphic encryption

There is a trade-off between the level of privacy protection provided by each method and the required computational resources. 

Strict regulations around data encryption, access controls, and auditing will be necessary to prevent breaches and protect patient rights. 

Medical decision making

Clark makes a final warning about implementing ACI systems to automate note-taking and other tasks in hospitals. She says shifting responsibility from the clinician to ACI “… could lead to legal discussions around liability in cases where decisions are influenced by AI. It’s crucial for hospitals and medical professionals to establish clear protocols and guidelines, and for legal frameworks to adapt to these changing dynamics, ensuring accountability without stifling technological advancements.”

By seamlessly integrating ACI into healthcare workflows, providers can streamline operations, enable continuous monitoring of patients, and leverage data-driven insights to inform diagnostic and treatment decisions. This integration can significantly improve patient outcomes and reduce the burden on healthcare workers, and ultimately enhance the quality of care they provide.

References

Augnito. How Ambient Clinical Intelligence is Advancing Real-Time Patient Care.

DeepScribe. Ambient Clinical Intelligence—What is it and how will it transform healthcare?

Harper, K. What is ambient clinical intelligence—and how is it transforming healthcare? Nuance. June 16, 2022.

Haque A., Milstein A., & Fei-Fei L. Illuminating the dark spaces of healthcare with ambient intelligence. Nature. 2020; 585(7824):194-198. doi:10.1038/s41586-020-2669-y 

Joshi, N. The Myriad of Applications of Ambient Intelligence in Healthcare. Forbes. January 9, 2022.