Introduction: The field of digital technologies in healthcare is rapidly evolving and has the potential to improve patient care substantially. Digital enhancement of clinical trials could facilitate data collection during follow-up (FU), for example for capturing patient-reported outcomes (PROMs). However, the digital capabilities of contemporary patient cohorts in the field of cardiology and patients’ willingness to participate in digitally enhanced clinical trials are not thoroughly studied.

Methods and Results: The Helios Heart registry (H²-registry) is a prospective multicentre heart failure (HF) registry based on digitally augmented processes throughout the whole trial conduction from patients’ selection to data collection and FU. Patients are offered two options for digital PROM-capturing during routine FU: a web-based vs. an application- (smartphone) based approach. A survey was conducted to assess patients’ preferences for mode of data collection during FU for the HF patient cohort within the H²-registry. The results were compared to an existing cohort of atrial fibrillation (AF) patients who participated in a similar survey.

During the first seven months from study initiation, 210 HF patients were included in the H²-registry at the Heart Centre Leipzig (Mean age: 67.8, 33.8% female). The majority (61%) was not interested in any digital solution for PROM assessment as part of the FU. Those patients were older (p<0.001) and more likely to be female (p<0.001). Main reason was the unavailability of an email address but 31 (14.8%) patients indicated to have an email address but did not want to provide it for study purposes. Among those patients where a digital contact was conceivable (39%), a web-based solution was preferred over the application-based approach (72.2% vs. 27.8%). Looking at the aforementioned AF cohort which comprises 107 patients (mean age 61.9, 29.9% female), different results could be observed. Among AF patients, 33.6% were not interested in a digital FU. There was a significant difference between digital and non-digital cohorts regarding age (p=0.012) but not with respect to female gender (p=0.075). Similar to the digital HF cohort, more patients (66.7%) preferred a web-based approach.

Discussion: The results of our survey highlight challenges in implementing digital solutions as part of FU in clinical trials mainly due to the unavailability of a digital infrastructure among older patients. However, differences between HF and AF patient cohorts were observed. Most patients seem to favour web applications over smartphone applications. During the process of digitizing clinical trials, specific cohort characteristics and patients’ preferences have to be assessed thoroughly. Future patient education programs could inform on the possibilities and advantages of digital technologies in healthcare to improve their availability.