Department of Informatics and Health Data Science, Miller School of Medicine, University of Miami, Miami, FL 33136, USA.
Department of Psychiatry and Behavioral Sciences, Miller School of Medicine, University of Miami, Miami, FL 33136, USA.
Int J Environ Res Public Health. 2023 Nov 27;20(23):7115. doi: 10.3390/ijerph20237115.
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; -value = 0.011) and clinical trial literacy (mean: 0.55 vs. 2.59; -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.
本随机试验的主要目的是检验 PREDHiCT 数字应用程序的有效性，该程序提供教育和支持性导航，以增加参与未来临床试验的意愿。第二个目标是检验 PREDHiCT 是否能提高临床试验素养或增强参与临床试验的心理促进因素，如利他主义。为了检验这两个目标，我们进行了为期 1 个月的远程分散试验，共有 100 名参与者参加，他们要么有心血管代谢健康状况（如高血压、糖尿病和肥胖症）的个人或家族史。结果表明，在对照组和干预组之间，从基线到 1 个月的随访，利他主义（均值：-2.94 与 0.83；-值=0.011）和临床试验素养（均值：0.55 与 2.59；-值=0.001）均有显著变化。此外，与研究对照组相比，接受个性化临床试验导航的参与者在研究结束时具有更高的临床试验素养。我们的研究结果表明，个性化教育、导航和获得临床试验的机会——我们的 PREDHiCT 应用程序的三个独特特征——增加了利他主义和临床试验素养，但没有增加参与试验的意愿。
