The Coronavirus Disease 2019 (COVID-19) pandemic curtailed clinical trial activity. Decentralized clinical trials (DCTs) can expand trial access and reduce exposure risk but their feasibility remains uncertain. We evaluated DCT feasibility for atrial fibrillation (AF) patients on oral anticoagulation (OAC). DeTAP (Decentralized Trial in Afib Patients, NCT04471623) was a 6-month, single-arm, 100% virtual study of 100 AF patients on OAC aged >55 years, recruited traditionally and through social media. Participants enrolled and participated virtually using a mobile application and remote blood pressure (BP) and six-lead electrocardiogram (ECG) sensors. Four engagement-based primary endpoints included changes in pre- versus end-of-study OAC adherence (OACA), and % completion of televisits, surveys, and ECG and BP measurements. Secondary endpoints included survey-based nuisance bleeding and patient feedback. 100 subjects (mean age 70 years, 44% women, 90% White) were recruited in 28 days (traditional: 6 pts; social media: 94 pts in 12 days with >300 waitlisted). Study engagement was high: 91% televisits, 85% surveys, and 99% ECG and 99% BP measurement completion. OACA was unchanged at 6 months (baseline: 97 ± 9%, 6 months: 96 ± 15%, p = 0.39). In patients with low baseline OACA (<90%), there was significant 6-month improvement (85 ± 16% to 96 ± 6%, p < 0.01). 86% of respondents (69/80) expressed willingness to continue in a longer trial. The DeTAP study demonstrated rapid recruitment, high engagement, and physiologic reporting via the integration of digital technologies and dedicated study coordination. These findings may inform DCT designs for future cardiovascular trials.

2019 年冠状病毒病 (COVID-19) 大流行减少了临床试验活动。分散式临床试验 (DCT) 可以扩大试验范围并降低暴露风险，但其可行性仍不确定。我们评估了心房颤动 (AF) 患者口服抗凝剂 (OAC) 的 DCT 可行性。DeTAP（在 Afib 患者中进行的分散试验，NCT04471623）是一项为期 6 个月、单臂、100% 的虚拟研究，对 100 名年龄大于 55 岁的 OAC AF 患者进行了传统和社交媒体招募。参与者使用移动应用程序和远程血压 (BP) 和六导联心电图 (ECG) 传感器进行注册和虚拟参与。四个基于参与的主要终点包括研究前后 OAC 依从性 (OACA) 的变化，以及电视访问、调查、心电图和血压测量的完成百分比。次要终点包括基于调查的令人讨厌的出血和患者反馈。在 28 天内招募了 100 名受试者（平均年龄 70 岁，44% 女性，90% 白人）（传统：6 分；社交媒体：12 天内 94 分，超过 300 名候补名单）。研究参与度很高：91% 的电视访问、85% 的调查、99% 的心电图和 99% 的血压测量完成。OACA 在 6 个月时没有变化（基线：97 ± 9%，6 个月：96 ± 15%，p  = 0.39）。在基线 OACA (<90%) 低的患者中，6 个月有显着改善（85 ± 16% 至 96 ± 6%，p  < 0.01）。86% 的受访者 (69/80) 表示愿意继续进行更长时间的试验。DeTAP 研究通过整合数字技术和专门的研究协调，展示了快速招募、高参与度和生理报告。这些发现可能为未来心血管试验的 DCT 设计提供信息。