Arrhythmias & electrophysiologyRandomised controlled trial
Direct-to-Participant Enrollment in a Virtual Trial
- randomized trial
- decentralized
- direct-to-participant recruitment
- multichannel
Authors' conclusion
The Heartline Study demonstrated the ability to recruit large numbers of participants aged ≥65 years. A direct-to-participant approach across multiple channels achieved excellent gender and geographic diversity, enrolling a higher percentage of women than typical cardiology trials and participation from rural areas. However, less racial and ethnic representation was achieved, highlighting the need for additional strategies to meet this goal. Future trials may consider such multichannel recruitment approaches to support decentralized clinical trials. (A Study to Investigate if Early Atrial Fibrillation [AF] Diagnosis Reduces Risk of Events Like Stroke in the Real-World; NCT04276441).
Study context
- Population
- U.S. adults aged ≥65 years with an iPhone and Medicare coverageparticipants completing enrollment (February 2020-December 2022), 321,272 applications installed, 28,155 completed baseline demographic assessments
- Participants
- 34,244 adults
Primary result
As reported in the abstract
Heartline Study applications installed
321,272
Participants completing enrollment
34,244 (11%)
Completed baseline demographic assessments, of those enrolled
82% (28,155/34,244)
Further findings
Participant demographics (of those completing baseline demographic assessments)
- Women
- 54.2% (15,258/28,155)
- White
- 93.0% (26,192/28,155)
- Asian
- 2.8% (781/28,155)
- Black
- 2.7% (747/28,155)
- Hispanic
- 2.5% (699/28,155)
- Broad geographic representation throughout the United States was achieved
Original publication
Summarised from the published abstract; every number is checked against it