Contributed Commentary by Aaron Timm, Vivalink 

November 8, 2024 | Ensuring clinical trial participants adhere to study protocols is essential for reliable clinical trial results. If participants aren't consistent with their participation, the data collected won't accurately reflect the effectiveness of a treatment or therapy. Poor adherence can slow down or even derail clinical breakthroughs. 

Wearable devices offer the advantage of remotely collecting continuous, real-time health data, providing researchers with regular insights into participants’ health and behavior, such as heart rate, sleep patterns, and activity levels. However, the efficacy of these devices depends on participants wearing them as prescribed, presenting different challenges than simply taking medication as directed. 

Addressing challenges related to participant adherence requires tailored approaches that cater to the specific needs of each participant and study population. Personalized technology solutions can overcome adherence barriers by offering continuous support, simplifying the user experience, and integrating wearable devices into participants' daily routines. 

Prevalence and Impact of Poor Adherence 

Participant adherence in clinical trials is a dynamic issue, constantly evolving throughout the research process. Several factors influence adherence over time, such as cumbersome technology, struggling with the complexity of the protocol, or a gradual loss of motivation as the trial progresses.  

A Vivalink survey found that nearly 70% of pharmaceutical companies and contract research organizations (CROs) view participant adherence as their top concern with remote patient monitoring (RPM) technologies in clinical trials. 

Adherence rates can vary significantly depending on the specific wearables used, the condition being studied, and the overall design of the clinical trial. Regardless, adherence must be monitored and encouraged through follow-ups and reminders to ensure participants comply with study protocols. 

Research has highlighted the need for strategies to improve adherence, especially in long-term studies. However, generic solutions may not meet the participants' unique needs and the study's specific data requirements. Sponsors can ensure participant adherence throughout trials and optimize wearable usage by leveraging tailored features like customized education materials or study-specific dashboards. 

Overcoming Technology Barriers  

Complex interfaces, unfamiliar functionalities, and compatibility issues can lead to participant frustration and abandonment in clinical trials. Research shows that users disengage with technology they find difficult to understand or operate. By partnering with RPM manufacturers who prioritize user-friendliness, sponsors reduce technology barriers: 

• Intuitive onboarding: Simple onboarding processes and intuitive wearables make it easy for participants to understand the technology. Pre-installed software on study-specific devices eliminates the need for participants to download it themselves, resulting in faster onboarding and streamlined trial operations. 

• Simplified device usage: Clear instructions, intuitive navigation, and helpful visual cues minimize user errors and ensure high-quality data collection. Customizing the app to include only study-specific features keeps information secure and prevents users from getting sidetracked. 
  
• Streamlined study management: If participants encounter technical issues, remote troubleshooting saves time and minimizes disruptions to the study protocol. Personalized assistance from a dedicated support team improves the participant experience and increases retention throughout the trial. 

Addressing Lifestyle Factors  

Managing multiple devices, remembering to wear them, and keeping them charged can disrupt participants' daily routines. Forgetting to wear or charge devices can lead to incomplete data collection and compromise the integrity of the study. Sponsors can benefit from vendors who understand the importance of incorporating wearables into a participant's daily routine: 

• Increased participant engagement: Tailored support materials and clear instructions, available in various formats such as printed guides, animated videos, and interactive tutorials, ensure participants understand how to use the wearables and incorporate them into their routines. 

• Wear-and-forget solutions: Lightweight and unobtrusive designs ensure comfort for extended wear, making it easier for participants to carry on with their daily activities. Waterproof or sweat-resistant materials allow users to wear them when showering or exercising. 

Mitigating Accessibility and Physical Limitations  

Illness or specific health conditions may hinder participants' consistent use of devices, especially if certain designs or functionalities conflict with their motivation or energy levels. By working with vendors that prioritize inclusive design, sponsors can reduce the burden on participants, particularly those with physical limitations: 

• Minimized logistical issues: Bundling devices, providing region-specific chargers, and simplifying device management — such as through automatic data syncing and minimal charging requirements — reduce the logistical challenges faced and the required effort.

• Personalized solutions: Ensuring device interfaces and accompanying materials are available in multiple languages and accessible formats eliminates barriers that could hinder participants' ability to navigate and understand device instructions. 

Managing Forgetfulness or Lack of Motivation 

Forgetfulness or lack of motivation can cause participants to overlook wearing or charging their devices, potentially compromising data integrity. The novelty of the devices can fade over time, leading to decreased adherence. By incorporating strategies to address forgetfulness, sponsors can encourage engagement throughout the trial: 

• Proactive communication: Regular check-ins and reminders ensure participants wear their devices as directed and upload data accordingly. If a participant misses consecutive days of device use, the study team receives notifications for prompt intervention. 

• Enhanced motivation: Comprehensive educational materials detail device usage, maintenance, and troubleshooting. By providing participants with the necessary materials and support to understand the device and its importance, sponsors can reduce the likelihood of participants becoming unmotivated. 

Role of Wearable Technologies in Supporting Clinical Trials 

Participant adherence to wearables in clinical trials presents a critical challenge for sponsors seeking to collect reliable data and achieve study objectives. By recognizing the various barriers to adherence, sponsors can implement tailored strategies to enhance participant engagement and data quality. 

Partnering with vendors offering customizable solutions and intuitive technology is essential for accommodating diverse participant needs and promoting sustained adherence throughout the trial. Prioritizing participant adherence not only enhances the integrity of study results but also advances medical research and improves patient care. 

Aaron Timm is Executive Vice President and Chief Commercial Officer at Vivalink, a leading provider of digital healthcare solutions. He drives commercial strategy and development for its rapidly-expanding customer base in clinical research and healthcare. Prior to joining Vivalink, Timm was CEO of WorldCare Clinical, a global imaging clinical research organization and Timm served as CEO of Synarc, a global imaging CRO. A graduate of Georgetown University and Harvard University, Timm’s career began in law, with experience as general counsel of both private and publicly-traded companies. He can be reached at aaron@vivalink.com.