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

Azizi Seixas (), Shannique Richards, Jesse Q. Moore, Chigozirim Izeogu, Laronda A. Hollimon, Peng Jin and Girardin Jean-Louis
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Azizi Seixas: Department of Informatics and Health Data Science, Miller School of Medicine, University of Miami, Miami, FL 33136, USA
Shannique Richards: Clinical Psychology, City College, City University of New York, New York, NY 10031, USA
Jesse Q. Moore: Department of Informatics and Health Data Science, Miller School of Medicine, University of Miami, Miami, FL 33136, USA
Chigozirim Izeogu: Department of Neurology, University of Texas Health Science Center at Houston, Houston, TX 77030, USA
Laronda A. Hollimon: Department of Informatics and Health Data Science, Miller School of Medicine, University of Miami, Miami, FL 33136, USA
Peng Jin: Department of Population Health, NYU Grossmann School of Medicine, New York, NY 10016, USA
Girardin Jean-Louis: Department of Psychiatry and Behavioral Sciences, Miller School of Medicine, University of Miami, Miami, FL 33136, USA

IJERPH, 2023, vol. 20, issue 23, 1-17

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.

Keywords: decentralized trials; clinical trial; health literacy; altruism (search for similar items in EconPapers)
JEL-codes: I I1 I3 Q Q5 (search for similar items in EconPapers)
Date: 2023
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