A recent feasibility study published in Scientific Reports has shed light on the potential and challenges of using digital decentralized clinical trials (DCTs) for research in Long COVID. The study, which recruited 85 participants with self-reported Long COVID, explored the use of a digital platform, Atom5™, to deliver interventions and collect patient-reported outcomes remotely.
The research team, led by investigators from [insert affiliation if available from context], aimed to assess the feasibility of conducting a fully remote trial, addressing key considerations for future DCT designs. The study enrolled primarily female (82.3%) and white (92.9%) participants, with a mean age of 46.1 years. Participants were randomized into four arms: pacing video, pacing book, pacing app, and usual care.
Recruitment Challenges and Solutions
One significant hurdle encountered during the recruitment phase was the identification of imposter participants. The research team noticed an unusually high number of sign-ups (n=111) originating from a single location in Lagos, Africa, within a single day. Further investigation revealed several red flags, including unusually quick registration times, a disproportionately high number of male participants, and the use of generic Gmail accounts. These individuals were suspected of being motivated by the vouchers offered upon randomization. As a result, the team implemented measures to prevent automatic voucher distribution and removed the fraudulent entries from the dataset.
Data Collection and Intervention Use
Data collection relied heavily on patient-reported outcome measures (PROMs) administered through the Atom5™ platform. While 91.7% of participants completed baseline PROMs, completion rates decreased at follow-up time points (weeks 4, 8, and 12), with just under half completing PROMs at week 12. The healthcare resource use questionnaire, prescription use, and private costs (non-prescription medication use/work productivity) were also collected. Most participants who completed the questionnaire at baseline had used healthcare services at least once (n=75, 94.9%). GP visits/calls and Long COVID clinics were the services most frequently accessed.
The feasibility questionnaire, completed by 28 participants at Week 12, indicated that most participants (85.7%) had used the interventions at least once. Fewer participants allocated to the pacing app group used the intervention than in the other intervention arms. Qualitative interviews revealed that participants were generally motivated to participate to support research, even if the outcome was not successful.
Participant Feedback and Platform Experience
Qualitative interviews provided valuable insights into the participant experience with the Atom5™ platform. Most participants reported that the randomisation process was seamless and that they were satisfied with their intervention allocation. However, one participant withdrew from the trial because of the study arm allocation (pacing app), explaining that they had used the pacing app before and disliked it.
Participants were generally positive about their experiences of using Atom5™, but several interviewees reported that although they had received notifications to complete questionnaires, they had to wait over a minute before receiving them or had to close and reopen the app for the questionnaires to appear. Several interviewees reported that they found the health resource use questionnaire too long and difficult to complete.
Implications for Future DCTs
The study highlights several key considerations for the design and implementation of future DCTs. These include the need for robust participant verification processes to prevent fraudulent sign-ups, strategies to improve participant engagement and retention, and careful attention to the design and usability of digital platforms. The clinical alert functionality within the digital platform which notified the clinical research team to contact them to provide advice if concerning symptoms were reported was particularly well-received. Participants found the phone call reassuring and felt acknowledged.
Overall, the study suggests that DCTs hold promise as a means of conducting research in Long COVID and other conditions, but careful planning and attention to participant feedback are essential for success.
