Vivalink, a digital healthcare solutions provider, recently published an e-report titled “A Sponsor’s Guide to Participant Adherence in Remote Data Collection for Clinical Trials,” which addresses the challenges and solutions related to participant adherence in remote and hybrid clinical trials. It highlights the impact of digital health technologies on transforming clinical trials by enhancing participant convenience, broadening recruitment, and offering flexible data collection methods. The report outlines the critical role of participant adherence in ensuring the validity of trial results. It presents strategies to improve adherence, including user-friendly remote patient monitoring (RPM) devices, personalized support, and real-time monitoring tools. Additionally, the report features a case study demonstrating how Vivalink’s comprehensive RPM solutions successfully maintained high adherence rates, streamlined trial operations, and ensured accurate data collection.
We had the opportunity to ask Mariel Fabro, the Head of Product at Vivalink, some questions about the report, RPM’s benefits, and the future of this technology.
Can you provide an overview of Vivalink’s recent e-report and key findings?
As healthcare delivery shifts to more digital models, we are also seeing an increase in hybrid and remote clinical trials. As with any large industry shift, this change brings its own challenges, primarily in ensuring patient adherence to study protocols and data collection using digital health technologies for RPM. This new e-report aims to provide guidance to study sponsors for utilizing RPM technology and cloud data monitoring features in a way that improves participant adherence and clinical outcomes. We’ve found that by harnessing the power of cloud data and the ability to monitor that data in real time, studies are able to maintain adherence, enable study participants in their user experience, streamline trial operations, and ensure accurate data collection.
The report emphasizes the importance of simple, user-friendly devices to promote adherence. Could you elaborate on some of the design considerations Vivalink implemented in its RPM devices?
Vivalink’s devices are designed with the patient end users in mind and a variety of human factors. This includes considerations in regard to their demographics, home environments, and physical or cognitive limitations. For example, our wearable ECG Multi-Vital Patch is capable of capturing a variety of physiologic parameters within a small and user-friendly form factor. It is reusable and rechargeable, and easily becomes part of a routine for a patient. It is also waterproof and can therefore remain on-body during normal showering, again becoming part of a normal routine. Another aspect of the wearables used in the Vivalink platform involves the automated wireless connection. The study participant does not have to take any actions to connect the Bluetooth pairing for the devices, which is automatically handled within the mobile application. This automatic control of the wireless data helps to ensure continuous stream of the data without burden to the study participant.
Lifestyle factors are mentioned as significant barriers to adherence. How can technology address these challenges to ensure participants can easily integrate devices into their daily routines?
By innovating devices that are compact, comfortable, durable, and easy to use, we can minimize the challenges various lifestyle factors may bring. Whether you’re a busy parent, a forgetful teenager, or a person with a disability, “wear and forget” devices allow patients to live their lives as-is without disruption to their normal routines to participate in a trial.
Speaking of “wear and forget” devices, can you describe what this means and what features of Vivalink’s devices support this approach?
A “wear and forget” device means that after a patient wears or applies the device on-body, their job is done. The device does all the work for them, monitoring the vitals data, transmitting the data and analyzing that data for anomalies without the participant having to take time to manually log this information themself. Wear and forget also refers to the connectivity aspect mentioned earlier, wherein the wireless connection and transmission are automatically handled by the mobile application receiving the data from the wearable devices. These devices allow patients to go about their activities of daily living as usual, and the less disruptive a device is to a patient, the more likely they are to use it consistently and accurately.
Can you provide more detail on the benefits of real-time monitoring?
Real-time monitoring has several benefits in improving the quality of data collected, and the continuity of that data to provide actionable insights. In a more traditional trial that may not utilize digital technologies, often episodic data can be collected, which may not be reflective of the patients’ condition as a whole and only shows a snapshot of what they’re experiencing. Additionally, entering a controlled clinical environment such as a study site may skew the data and is not representative of what a patient may be experiencing in the real world. With real-world data, we can learn exactly what a patient is experiencing in their natural environment and how this changes over time. Additionally, we can monitor for any adverse events and implement interventions as-needed in a timely manner.
Can you explain the role of Vivalink’s customizable dashboards and alerts in enhancing participant adherence and trial outcomes?
Vivalink provides dashboards for tracking patient compliance/adherence to protocol. These dashboards monitor the cloud data as it streams in continuously, and provide a daily summary of the data completeness. For example, if a certain volume of wearable data is expected within a 24 hour period, the dashboard can summarize what percentage of expected data has been transmitted to the cloud. Additionally, any data relevant to patient-reported-outcomes (ePROs) can be monitored in the same fashion, and reported upon using these dashboards. This provides study teams the ability to track the participant’s progress in completing protocol-driven tasks, or usage of the wearable technologies.
The alerting mechanism within Vivalink’s system can be used to help manage patients. In particular, physiologic data from the wearable devices can be monitored continuously and alerts can be triggered as these data reach threshold values. Additionally, any detected anomalies from these data, such as aberrant heart rhythms, abnormal activity levels, or ePRO responses can trigger alerts. This allows for timely intervention based on the care team or study team’s assessment of the patient status.
What kind of training and support does Vivalink provide to participants and site staff?
Vivalink employs a comprehensive training program for study staff. This may follow a train-the-trainer model or each individual study site team may be trained. The training is typically conducted remotely, with instruction provided on the wearing and application of the devices, the use of the mobile application, and the use of various dashboards for the study personnel. Study participants receive instructional materials with the study device kits, both in printed form and digital form within the mobile application. Vivalink’s customer support team is available to answer any questions on the use of the technology and to provide troubleshooting or issue resolution for study staff throughout the study.
What are the next steps for Vivalink in enhancing remote patient monitoring technologies for clinical trials?
A key aspect of RPM technologies for successful implementation is that they are “fit-for- purpose.” In this context, Vivalink aims to create RPM solutions that are fit for purpose within therapeutic areas and for specific use of the data. For example, the combination of wearable devices, parameters derived, and mobile app ePRO features can be pre-configured and tailored to address specific therapeutic areas, conditions, or indications. The typical digital measures, digital endpoints, and safety assessments relevant for studies within that domain would be readily available in these pre-configured modules.
Additionally, the data itself would be configured to be fit-for-purpose. For example, the data may be intended for ingestion into certain clinical study databases or electronic data capture (EDC), the Vivalink platform would aim for this ingestion to occur seamlessly across a variety of database structures, trial management systems, or EDC platforms. Alternatively, the data may be intended for ingestion into research or data science processing pipelines and Vivalink is building the mechanisms to more easily feed into those processing pipelines.
The goal here in enhancing RPM technologies is to make them easier to implement with clinical study operations and workflows and harness the power of the data itself and enable broader use of the data.
What advancements in remote patient monitoring technologies do you foresee in the next five to ten years?
RPM technologies largely rely on advancements within sensing technology and data infrastructure, and data processing/analysis. Within the next decade, sensing technology will continue to evolve to become more powerful within smaller form factors, especially with the possibility of quantum sensing. The technologies will extend beyond traditional electrical, mechanical, or optical sensors. We will begin to see technologies that can sense biochemical composition or utilize ultrasound and other ranges of the electromagnetic spectrum. These will allow assessments of more organ functions similar to how diagnoses and assessments are made in hospital environments but in smaller formats. This will likewise add to even more data and the need for advanced infrastructure, as well as the processing of it into structured data that can be incorporated into typical clinical workflows.
How do you see the role of artificial intelligence and machine learning in enhancing the capabilities of RPM technologies?
The use of AI and ML in RPM is firstly applicable to converting raw data from wearable sensors into derived insights that allow clinicians to make assessments on irregularities in the physiology, decompensation, or deterioration. This is already existent in certain algorithms that have been fully validated and cleared for use. This implementation of AI and ML will continue to be applied more commonly as the type of data and amount of data continues to grow, thereby creating a need for efficient and timely clinical assessments from this volume of data.
There is a lot of curiosity in using generative AI to streamline clinical assessments and patient-physician interactions to ultimately guide care pathways, and this is somewhat applicable to RPM technology as it is used to enable such assessments and interactions. This use of AI will take more time to be adopted, given the current practices in healthcare and clinical research, the related risks of shifting some of those practices, and the nuances of caring for patients, and the variation within patient populations. More likely, generative AI will be used to offset administrative tasks or data-driven routines, and this also applies to certain features within RPM technologies. As study participants or patients engage with the RPM technology, the routines they are intended to follow can be somewhat streamlined by the use of generative AI, perhaps based on their previous responses or based on contextualizing data that would allow for an AI model to make predictions of their next step. Also, utilizing the natural language processing aspect, we can imagine that generative AI would enable RPM technologies to take in a spoken or written prompt from the study participant or patient which can then enable information or routines to be generated based on that prompt and any additional data within the system. This type of implementation can easily be foreseeable within the near term.
Thank you to Mariel Fabro for answering our questions and providing insights into the future of RPM technology. It is great to see that solutions like Vivalink’s are easing the burdens on participants and providing researchers with an even wider range of reliable data to develop new treatments and enhance patient care. We look forward to covering future developments in this field.
