How DCT technology can address data capture challenges in LTFU studies

There are a lot of methodologies for keeping patients engaged through a typical trial period. However, due to the nature of long-term follow-up studies, it is often unnecessary to communicate with patients on a daily or even weekly basis, as the frequency of patient data collection in long-term follow-up studies is much lower than that of other clinical studies. Part of the challenge in ensuring that the right, quality patient data is being collected over a long period of time is deciding the precise modality, frequency, and cadence at which patients are interacted with and data is collected. 

Often the methodology of patient data collection does not need to be changed too much. If patients are comfortable with telemedicine, online surveys, phone calls, etc., it can be beneficial for long-term follow-up studies to give patients the same optionality in how they want to participate in the trial and make data collection as convenient for patients as possible. It is also important to map out exactly what is required from patients and when to inform them of what to expect next in tandem with appropriately timed messages, reminders, and notifications to keep patients on track over this extended period of time. 

Communication timing

When it comes to long-term follow-up studies, patients may not need to do anything for months at a time. During these breaks in activity, it is crucial to ensure that patients are still engaged and retained in the study without pestering them with abundant messaging. Large gaps in communication can result in significant drops in patient retention. Tools such as countdowns until the next required task, phone check-ins, monthly reminders to log in, etc., can help keep patients aware of the participation timelines and minimize gaps in activity while also making sure patients are contacted only when appropriate. 

Leveraging Technology 

When it comes to collecting a full set of patient data in a long-term follow-up study, the less patient burdens the better. Decentralized clinical trial technology can be infused into LTFU studies to directly address the patient burdens that exist in traditional studies. For example, it is unnecessary and often unrealistic to ask patients to revisit a physical site location every month or 3 months to give their data. It is also unrealistic to expect traditional sites to manage follow-ups and remind patients to fill out complex data reports. By implementing a virtual site model in tandem with an easy-to-use eClinical platform and seamless ePRO notification workflows, participation in LFTU trials can be completely virtual, allowing patients to participate on their own time, with the device of their choosing. 

Engaging UX/UI 

Having a convenient patient-friendly eClinical platform or app that patients can access from the device of their choice is the foundation for successful patient retention. This platform should be equipped equipped with user-friendly components for optimal patient experience and engagement. These can be checklists, road maps, timelines, calendars, reminders, upcoming tasks, etc. that help patients move through the trial over a long period of time. With these tools, patients are able to track their progress with motivation to complete the next step in their checklist and move to the next level. This also helps patients with understanding where they are in the study and what they have left to complete and when.  

A patient-centric study design is crucial in obtaining high-quality patient data collection in long-term follow-up studies. By allowing patients to choose how to participate, choose how/when they receive their notifications, and choose the modality for completing an appointment or giving a sample, participation in these types of extended trials is much more convenient for patients. When patients aren’t facing accessibility barriers such as travel requirements and lack of communication, they are more likely to continue participating in and having a better experience in a  LTFU study. Furthermore, using DCT technology and tools to collect patient feedback about their experience, pain points, or recommendations can be useful for monitoring and troubleshooting any complications in a current trial but can also be used to inform how to design future long-term follow-up trials and ensure that your next LTFU study is set up for success.