Leader: Daniela Capello (UPO); Other collaborator(s): Lorenzo Schiavon (UNIVE)
Design and pilot a novel and innovative cohort study on aging enrolling and carry out a longitudinal and cross-sectional collection and analysis of biological, health, life-style and socioeconomic data to fill gaps of previous and already available cohorts
The Novara Cohort Study, launched on November 7, 2023, has made significant strides since its inception.
Scientific Paper Under Submission: A scientific paper detailing the outcomes of the pilot study involving 123 participants is currently undergoing submission. This paper promises to offer valuable insights into the initial findings and methodologies employed in the study. Enrollment Success: By March 15, 2024, the study has exceeded expectations, with over 200 participants already enrolled and more than 300 awaiting inclusion. This high level of enrollment demonstrates strong community engagement and interest in the study. Passive Follow-Up Protocols: Efforts are underway to establish protocols for passive follow-up, enabling the collection of longitudinal data from hospitals and local health centers. This aspect of the study will provide valuable insights into health trends over time. Laboratory Analyses: Ongoing proteomic and metabolomic analyses are being conducted on biological samples collected from participants. These analyses will contribute to a deeper understanding of biological markers associated with aging and health outcomes. Focus Groups and Questionnaires: In the near future, focus groups will be convened, and questionnaires will be administered to participants to evaluate their motivations, satisfaction, and perceived effects of participation. This qualitative data will complement quantitative findings and provide valuable insights into participant experiences. National Congress on Health Data and Biobanking: The convening of a national congress on "Health Data, Biobanking, and Biomedical Research: Opportunities and Challenges" on October 5, 2023, provided a crucial platform for discussing key issues in healthcare data management and biobanking practices. The event likely facilitated collaboration and knowledge exchange among stakeholders in the biomedical research community.
Brief description of the activities and of the intermediate results
The Novara Cohort Study (NCS) is a longitudinal research project aimed at evaluating the long-term health and aging outcomes of citizens in the Novara area. It involves a comprehensive collection of biological samples and detailed demographic, lifestyle, clinical, and biological data. Data management is done in collaboration with the UPO Biobank, ensuring proper storage and future access for analysis. The recruitment process remains a key component of the study, with 300 participants currently enrolled.
A study has been initiated to evaluate the perception and lifestyle impact of participating in the project.
Main policy, industrial and scientific implications
Contact has been made with patient associations and several biotech companies for the establishment of a stakeholder committee and the drafting of a collaboration agreement with the NCS and UPO Biobank activities.
The project has been presented to general practitioners, highlighting that health data generated by the study may help in implementing preventive healthcare actions for their patients. The number of samples and data collected is sufficiently representative and adequate to begin association analyses between health outcomes and hematochemical parameters evaluated at the time of participation.
Brief description of the activities and of the intermediate results
Recruitment continues successfully, with 500 participants now involved and at least 700 awaiting participations. A paper has been submitted that describes the pilot study and provides a characterization of the population involved so far, based on demographic, health, and hematochemical data.
A project has also been launched, involving focus groups aimed at evaluating personal perceptions of aging.
Main policy, industrial and scientific implications
An update is underway for the study's information sheet, consent form, and a protocol for sharing health data with ASL Novara. This collaboration lays the groundwork for building a fruitful interaction between research and local healthcare services, marking the first and only experience of its kind in the Piedmont region.
The data collected thus far allows the launch of an integrated study using deep learning techniques to analyze hematochemical parameters and functional data to define a laboratory index for frailty, the most frequent and socio-economically impactful form of accelerated aging.
Brief description of the activities and of the intermediate results
Recruitment is progressing successfully, with 700 participants already enrolled and at least 700 more awaiting participation. Efforts continue to engage a diverse population, ensuring representation across different age groups and backgrounds.
Main policy, industrial and scientific implications
As part of the study’s social and psychological assessment, approximately 300 participants have completed questionnaires exploring their experience of participating in the Novara Cohort Study (NCS). These surveys aim to assess perceptions, motivations, and the perceived benefits or concerns related to long-term involvement in the study.
Data analysis is currently underway and will be complemented by qualitative interviews to gain deeper insights into participants' perspectives. The findings will be synthesized into a publication analyzing the perception and impact of NCS participation among Novara citizens, contributing to the broader discussion on public engagement in longitudinal cohort studies
Laboratory data, questionnaires, and physical tests related to motor capacity and autonomy are being collected to identify biochemical profiles associated with frailty.
Information on cognitive reserve and the Montreal Cognitive Assessment (MoCA)—a screening tool for mild cognitive impairment—is being gathered and analyzed in relation to the Big Five Inventory (BFI), which assesses personality traits.
Scientific Reports has accepted a paper that presents the pilot study and offers a characterization of the enrolled population based on demographic, health, and hematochemical data.