COVID-19 studies in healthcare workers
in University of Mainz
Integra IT had the opportunity to participate and contribute with its tools in observational COVID-19 studies conducted by the University of Mainz on COVID-19 and its impact on healthcare workers. It was the first project of developed Integra IT in Germany. The project collected data on SARS-CoV-2 infection by studying the measurement of specific antibodies, as well as the evaluation of the COVID-19 disease. The study subjects were healthcare professionals of both genders.
They were included in an earlier longitudinal cohort study of COVID-19 disease and infection at the University Medical Center of the Johannes Gutenberg University of Mainz, located in the center of Mainz, a major city in the metropolitan Rhine-Main Region in Germany.
The University Medical Center of Mainz operates over 1,500 hospital beds, every year, almost 70,000 patients are treated on an inpatient basis, and approximately 280,000 patients visit the specialized outpatient clinics. More than 1,200 doctors and 2.900 nurses work daily at the Center.
“The TrialPal mobile application made it possible for us to continuously collect a large number of data sets from our study participants at a high frequency. Thanks to the Integra IT team who reacted quickly and flexibly to a pandemic situation and created interfaces to our study systems in order to optimally integrate the application into our processes. Together, we have made good progress in vaccine development”. –University Medical Center of the Johannes Gutenberg University of Mainz
Integra IT had already worked on a project developed by the same sponsor in Peru that sought to evaluate the safety, reactogenicity, and immunogenicity of the CVnCoV vaccine against COVID-19, which made it easier to understand the expected outcomes and used the gained experience to execute the project in record time.
The Integra IT
Our TrialPal Mobile App (eCOA/ePRO) was the tool used to collect information from participants in this COVID-19 study on healthcare workers.
Surveillance, one of the main modules of the TrialPal solution, allows the trial participants to report actions to the research site. It was ideal for trial surveillance where subjects must report their health status, symptoms, or emergencies regularly as in this case. For this project, the App obtained weekly data from 3665 participants at its peak. The biweekly average was 3530 reports, reflected in the high adherence to the application of up to 97%.
TrialPal collects and displays data in real-time so that trial surveillance teams can make quick and effective contact with volunteers who report symptomatology.
“The Integra IT team did a wonderful job developing and implementing a mobile application, which was used to collect data on SARS-CoV-2 infections in a large epidemiological cohort study in Mainz, Germany. At P95 Belgium, we appreciate Integra’s agile and efficient technical support and look forward to continued collaboration.”
and lessons learned
- Integra IT achieved a successful clinical trial operation in the European continent and the native language, thanks to the TralPal intuitive design and high-end technology.
- The flexibility and adaptability of our solutions were vital to the project’s development, as they integrated with the data center of the University Medical Center of the Johannes Gutenberg University of Mainz. The collected data was stored in a highly secure local server, in compliance with German and European regulations – GDPR, which shows the flexibility of Integra IT solutions.
- The TrialPal versatility made it possible to work with a custom API integration that allowed the correct operational performance of the trial on the in-house platforms. Thanks to this effort, the development team managed to deploy the functionalities of the Patient Follow-up System – PFS in record time, so the communication between systems was impeccable.
- The project had high adherence levels thanks to the continuous communication among the subjects and the TrialPal tool’s alert system, which sends notifications to their cell phones, reminding them to complete the reports. The virtualization improved the experience of researchers as well as enhanced the participant’s inclusion.
- Integra IT team addressed the main challenges with agile and flexible decision-making. Communications between the stakeholders we’re essential for success.
- This project represented an important point for the Integra IT presence in Germany and Europe. It contributed to the visibility of TrialPal in the Apple App Store and the Android Play Store in that region.
- This proyect increase Integra IT expertise in COVID-19 studies.