Zhelyazkova Ana, Koletzko Sibylle, Adorjan Kristina, Schrimf Anna, Völk Stefanie, Koletzko Leandra, Fabry-Said Alexandra, Osterman Andreas, Badell Irina, Eden Marc, Choukér Alexander, Tuschen Marina, Koletzko Berthold, Hao Yuntao, Tu Luke, Török Helga P, Wichert Sven P, Le Thi Thu Giang
Institut für Notfallmedizin und Medizinmanagement (INM), LMU Klinikum, LMU München, 80336 Munich, Germany.
Department of Pediatrics, Gastroenterology and Nutrition, School of Medicine Collegium Medicum, University of Warmia and Mazury, 10-561 Olsztyn, Poland.
Infect Dis Rep. 2025 Jul 24;17(4):88. doi: 10.3390/idr17040088.
: The longitudinal RisCoin study investigated risk factors for COVID-19 vaccination failure among healthcare workers (HCWs) and patients with inflammatory bowel disease (IBD) at a University Hospital in Germany. Since the hospital served as the study sponsor and employer of the HCW, we implemented a custom mobile application. We aimed to evaluate the implementation, adherence, benefits, and limitations of this study's app. : The app allowed secure data collection through questionnaires, disseminated serological results, and managed bidirectional communication. Access was double-pseudonymized and irreversibly anonymized six months after enrollment. Download frequency, login events, and questionnaire submissions between October 2021 and December 2022 were analyzed. Multivariable logistic regression identified factors associated with app adherence. : Of the 3979 participants with app access, 3622 (91%) used the app; out of these, 1016 (28%) were "adherent users" (≥12 submitted questionnaires). App adherence significantly increased with age. Among HCW, adherent users were more likely to be non-smokers ( < 0.001), working as administrators or nursing staff vs. physicians ( < 0.001), vaccinated against influenza ( < 0.001), and had not travelled abroad in the past year ( < 0.001). IBD patients exposed to SARS-CoV-2 ( = 0.0133) and those with adverse events following the second COVID-19 vaccination ( = 0.0171) were more likely adherent app users. Despite technical issues causing dropout or non-adherence, the app served as a secure solution for cohort management and longitudinal data collection. App-based cohort management enabled continuous data acquisition and individualized care while providing flexibility and anonymity for the study team and participants. App usability, technical issues, and cohort characteristics need to be thoroughly considered prior to implementation to optimize usage and adherence in clinical research.
纵向的RisCoin研究调查了德国一家大学医院的医护人员(HCW)和炎症性肠病(IBD)患者中新冠病毒疫苗接种失败的风险因素。由于该医院是该研究的赞助商以及医护人员的雇主,我们开发了一款定制移动应用程序。我们旨在评估本研究应用程序的实施情况、依从性、益处和局限性。:该应用程序允许通过问卷进行安全的数据收集、传播血清学结果并管理双向通信。访问在注册六个月后进行双重假名化并不可逆地匿名化。分析了2021年10月至2022年12月期间的下载频率、登录事件和问卷提交情况。多变量逻辑回归确定了与应用程序依从性相关的因素。:在3979名有权访问应用程序的参与者中,3622人(91%)使用了该应用程序;其中,1016人(28%)是“依从用户”(提交了≥12份问卷)。应用程序依从性随年龄显著增加。在医护人员中,依从用户更有可能不吸烟(<0.001),担任行政人员或护理人员而非医生(<0.001),接种过流感疫苗(<0.001),并且在过去一年中没有出国旅行(<0.001)。接触过SARS-CoV-2的IBD患者(=0.0133)以及在第二次新冠病毒疫苗接种后出现不良事件的患者(=0.0171)更有可能是应用程序的依从用户。尽管技术问题导致退出或不依从,但该应用程序是队列管理和纵向数据收集的安全解决方案。基于应用程序的队列管理能够实现持续的数据采集和个性化护理,同时为研究团队和参与者提供灵活性和匿名性。在实施之前,需要充分考虑应用程序的可用性、技术问题和队列特征,以优化临床研究中的使用和依从性。