Precision Recruitment and Engagement of Individuals at Risk for Diabetes and Hypertension in Clinical Trials (PREDHICT): A Randomized Trial for an E-Persuasive Mobile Application to Inform Decision Making about Clinical Trials

Abstract

The primary objective of this randomized trial was to test the effectiveness of the PREDHiCT digital application, which provides educational and supportive navigation to increase willingness to participate in a future clinical trial. The second objective was to test whether PREDHiCT increased clinical trial literacy or enhanced psychological facilitators of clinical trial participation, such as altruism. To test these two objectives, we conducted a 1-month remote decentralized trial with 100 participants who either have a personal or family history of cardiometabolic health conditions, such as hypertension, diabetes, and obesity. Results indicated significant changes in altruism (mean: −2.94 vs. 0.83; p-value = 0.011) and clinical trial literacy (mean: 0.55 vs. 2.59; p-value = 0.001) from baseline to 1-month follow-up between the control and intervention groups. Additionally, participants exposed to personalized clinical trial navigation had greater clinical trial literacy at the end of the study relative to the individuals in the control arm of the study. Our findings indicate that tailored education, navigation, and access to clinical trials—three unique features of our PREDHiCT app—increased altruism and clinical trial literacy but not willingness to participate in a trial.