Recruitment Strategies of a Decentralized Randomized Placebo Controlled Clinical Trial: The Canagliflozin Impact on Health Status, Quality of Life and Functional Status in Heart Failure (CHIEF-HF) Trial

Abstract

There has been growing Interest in patient-centered clinical trials using mobile technologies to reduce the need for in-person visits. The CHIEF-HF trial was designed as a double-blind, randomized, fully decentralized clinical trial (DCT) that identified, consented, treated, and followed participants without any in-person visits. Patient-reported questionnaires were the primary outcome, which were collected by a mobile application. To inform future DCTs, we sought to describe the strategies used in successful trial recruitment. This paper describes the operational structure and novel strategies employed in a completely DCT by summarizing the recruitment, enrollment, engagement, retention, and follow-up processes used in the execution of the trial at 18 centers. A total of 18 sites contacted 130,832 potential participants, of which 2,572 (2.0%) opened a hyperlink to the study website, completed a brief survey, and agreed to be contacted for potential inclusion. Of these, 1,333 were eligible and 658 consented with 182 screen-failures, primarily due to baseline Kansas City Cardiomyopathy Questionnaire scores not meeting inclusion criteria, resulting in 476 participants being enrolled (18.5%). There was significant site-level variation in the number of patients invited (median = 2,976; range 73-46,920) and in those agreeing to be contacted (median = 2.4%; range 0.05% - 16.4%). At the highest enrolling site, patients contacted by electronic medical record portal messaging were more likely to successfully opt-into the study than those contacted by email alone (7.8% vs 4.4%). CHIEF-HF used a novel design and operational structure to test the efficacy of a therapeutic treatment but marked variability across sites and strategies in recruiting participants was observed. While this approach may be advantageous for clinical research across a broader range of therapeutic areas, further optimizing recruitment efforts is warranted. NCT04252287: https://clinicaltrials.gov/ct2/show/NCT04252287.