Leader: Andrea Ungar (UNIFI); Other collaborator(s): Francesca Cecchi (UNIFI); Andrea Giustina (UNISR); Guglielmo Bonaccorsi (UNIFI); Alessio Faralli (UNIFI)
The general objective is that of the identification of frailty and multidisciplinary intervention in patients with cardiovascular diseases, in order to identify the markers and predictors of frailty and to assess: 1. the prevalence of frailty in older adults according to different measure tools and verify the prognostic role of frailty on functional decline. 2. prognostic role of frailty on diverse adverse clinical outcomes. 3. the relationship between cardiovascular diseases and different adverse clinical outcomes by frailty status
Brief description of the activities and of the intermediate results: In November, we conducted a preliminary analysis of the data collected thus far in the REMOTE 2 study. Additionally, following the preliminary analysis conducted this summer in the REMOTE 1 study, we resumed participant recruitment and the collection of follow-up data for patients with Implantable Loop Recorders, specifically those with carotid sinus hypersensitivity and a history of syncope and falls. Regarding the study protocol for the “THE” project, in which we are collaborating with other researchers from Spoke3, we identified continuous glucose monitoring devices of interest for use in the study’s development.
In December, we progressed with the recruitment and follow-up of patients in the MULTI-REMOTE CONTROL project. From December 13th to 16th, we also attended the SIGG National Congress in Florence, where we presented the preliminary results of the REMOTE 1 study. Additionally, we participated in various meetings, with other researchers involved in the “THE” project to finalize the details of telemedicine study protocols.
In January our group has carried out the MULTI-REMOTE study, focused on the management and monitoring of cardiovascular diseases in the older population. Specifically, we have continued enrolments in the two sub-studies REMOTE 1 and 2. Additionally, we have conducted a preliminary analysis of the data from the REMOTE 2 study and we have submitted an abstract with the preliminary data from the REMOTE 1 study to the Age-IT Congress in Venice, scheduled for next May.
In February 2024, we continued enrolments in the REMOTE 2 study and collected follow-up data from patients enrolled in the REMOTE 1 study thus far.
During March 2024, we continued the enrolment/data collection work for both studies. As part of our collaboration with other research groups within the project, we have also finalized purchase requests using PNRR funds for some materials useful for research purposes (glucose monitoring systems) to be used in the multiparametric monitoring project for the elderly. Additional purchases will be completed soon.
Main policy, industrial and scientific implications: These research activities aim to promote and expand the evidence on the role of implantable and wearable monitoring devices in frail older patients with multiple cardiovascular comorbidities and beyond.
During the second quarter of 2024, progresses was made in data collection and analysis of MULTI-REMOTE study. The team received confirmation of the acceptance of preliminary findings from the REMOTE1 sub-study for presentation at the national AgeIT Congress. Additionally, the Finapres® NOVA hemodynamic monitoring system, funded by the PNRR project, was delivered.
In May, the team participated in the Age-IT Conference at Ca' Foscari University in Venice, where they presented the preliminary results of the REMOTE1 sub-study. These results were based on 80% of the enrolled population, including initial follow-up data. The conference also provided valuable opportunities for networking with researchers from across Italy, laying the groundwork for future collaborations.
Work on the REMOTE2 sub-study also advanced, with around 60% of the sample size enrolled, and follow-up data analysis began. By June, preliminary analyses of the REMOTE2 follow-up data were ongoing, with the aim of producing reports and abstracts for conferences scheduled in the second half of the year. The team also submitted a contribution based on REMOTE1 to the EUGMS 2024 Congress.
Meanwhile, technical support for the Finapres® Nova system was delayed due to procurement issues. Lastly, several coordination meetings were held with the DIEF and DIDA working groups at the University of Florence, in connection with the THE project, to advance the development of the older glycaemic monitoring project.
During the third quarter of 2024, the team moved forward with the ongoing research projects. In July, confirmation was received for the presentation of the latest updates from the REMOTE1 sub-study at the EUGMS 2024 Congress. The team also completed statistical analyses for the REMOTE2 sub-study and submitted an abstract to the 2024 National SIGG Congress. In August, continuous glucose monitoring (CGM) devices were received to start with a new study project, investigating the correlation between intensive glycaemic control and the risk of falls in frail elderly individuals. This study is being conducted in collaboration with the DIDA and DIEF groups, affiliated with the THE project, at the University of Florence. Meanwhile, research activities on both the REMOTE1 and REMOTE2 studies continued.
In September, the team participated in the EUGMS 2024 Congress in Valencia, presenting the preliminary results of the REMOTE1 sub-study as a digital poster. Additionally, documentation for the CGM and falls study was submitted to the local Ethics Committee for approval.
During the period October–December 2024, the second analysis of the data collected so far in the REMOTE 2 study was conducted, and the results were presented as a contribution to the "Age Florence" event held in Florence on December 19, 2024. We are currently awaiting the collection of the final follow-up data from the REMOTE 1 study, which will allow us to proceed with the final phase of the study over the course of the coming year.
In December, the project on CGM and falls in the elderly was also reviewed during the session of the local Ethics Committee. On that occasion, however, a provisional opinion was issued, and our team is currently working on optimizing the protocol in accordance with the observations provided by the Ethics Committee.
We are still waiting for technical support for the Finapres® Nova system, as unfortunately, the university offices are significantly delayed in processing the administrative procedures.
Dissemination