Leader: Jacopo Lenzi (UNIBO); Other collaborator(s):
Task 1 will start with an analysis of the literature and of the administrative datasets as well as of the relevant clinical registers to select one or more populations targeted by programs of health promotion and/or prevention. The main output of the Task is to build a data platform integrating individual-level databases on healthcare services with supply-side databases on the type of interventions provided by primary care professionals (including incentives for GPs), specialist practitioners and intermediate care structures (home care, community homes, community hospitals, residential care homes). The Task aims at providing a pilot study on how to supplement the databases typically used by policy makers with more specific details on the relevant supply-side aspects affecting the implementation of prevention programmes.
Brief description of the activities and of the intermediate results
November/December 2023: Completion of data-linkage activities to build a retrospective cohort of residents in the LHA of Romagna with an estimated onset of type 2 diabetes in 2015–2017, with follow-up until 2022. Administrative databases include Hospital Discharge Records, Residential Care Discharge Records, Mental Health Information System, Outpatient Pharmaceutical Database, and Vital Registration System. A multistate survival analysis is performed to investigate the risk of major depression and dementia in these patients, including dementia resulting from depression, and their impact on diabetes-related complications and mortality. The findings are submitted to Diabetes Care and Clinical Practice.
January/February 2024: The manuscript, revised based on reviewers’ feedback, is published online. The key findings are presented at the AGE-IT Spoke 10 Workshop, and a short paper is submitted to the AGE-IT General Meeting scheduled for May 2024. A new paper investigating the relationship between the age of onset of type 2 diabetes and dementia is under construction and is expected to be submitted to Diabetes Care in May 2024. This study aims to provide practical insights into the correct target age and timing for cognitive screening in incident cases of diabetes.
March 2024: Launch of a study aimed at assessing the uptake of recommended vaccines in individuals with diabetes. To determine policy and practice implications for promoting compliance with these vaccinations, we will evaluate potential determinants of vaccine uptake, including proximity to “Ambulatori dell’igiene pubblica” and “Case della comunità”, and characteristics of the “Nuclei di cure primarie” of family doctors. We held meetings with colleagues from the Public Health Department of Romagna’s LHA to define the technical aspects required for data extraction.
Main policy, industrial and scientific implications
Our multi-state analysis suggests that patients with depression are more likely to experience diabetes complications than those with diabetes alone. This underscores the need for integrated physical and mental healthcare to foster medication adherence and glucose control, aiming to prevent the impact of depression on self-care and self-efficacy. We also identified depression as a risk factor for dementia, especially two years after diabetes onset, suggesting shared pathophysiological mechanisms that involve both conditionsOur study further emphasizes the impact of depression and dementia on mortality. This reinforces the cruciality of integrating early strategies for optimal diabetes control, reduced diabetes distress, and preserved cognitive function. Collaborative models involving primary and specialist care professionals may enhance the management of these comorbidities through the introduction of early psychosocial screening activities, mental health interventions, and targeted treatments within diabetes care pathways.
The latest ADA “Standards of Care in Diabetes” recommend the screening of all patients with type 2 diabetes for depression and anxiety during the initial visit and at regular annual check-ups. When indicated, the guidelines advise collaborative referrals to behavioral or mental health professionals for comprehensive evaluation and targeted treatment. The ADA proposes a similar approach to assess cognitive performance in individuals aged ≥65 and, in case of altered ability to perform self-care behaviors, suggests involving a laycare professional to serve the capacities of day-to-day monitoring. The guidelines also emphasize the importance of simplifying diabetes treatment plans.
To reduce the share of complications and mortality attributable to post-diabetes depression and dementia, it is imperative to integrate the ADA’s standards of care into clinical practice and promote their adoption across diabetes care pathways.
Brief description of the activities and of the intermediate results
- In collaboration with Prof. Briana Mezuk, visiting professor at UNIBO from the University of Michigan, we prepared a scientific article investigating the relationship between the age of onset of type 2 diabetes and dementia. This retrospective cohort study aims to provide practical recommendations on the optimal age and timing for cognitive screening in newly diagnosed cases of diabetes. Data were drawn from the healthcare administrative records of residents in Romagna, Italy, with an estimated onset of type 2 diabetes between 2008 and 2017, aged ≥55, and followed up until 2020. On June 24, 2024, the results were published in Diabetes Care and Clinical Practice: https://pubmed.ncbi.nlm.nih.gov/38925296/.
- Presentation of the study “A Multi-State Analysis of Disease Trajectories and Mental Health Transitions in Patients with Type 2 Diabetes”, published in Diabetes Research and Clinical Practice in February 2024 (https://pubmed.ncbi.nlm.nih.gov/38325659/), at the UNIBO Age-IT meeting in Bologna on May 10, 2024.
- Presentation of the same study at the Venice AGE-IT General Meeting on May 21, 2024.
Brief description of the activities and of the intermediate results
- Conducted a retrospective cohort study on the impact of depression on adherence to guidelines for managing type 2 diabetes. The results revealed a significant decline in adherence to regular check-ups among elderly patients with depression during the pandemic (2021–2022). The study underscores the importance of integrated care models to improve care processes and health outcomes for patients with diabetes. The results were submitted to Healthcare (Basel) and published online on September 27, 2024: https://www.mdpi.com/2227-9032/12/19/1942.
- On September 16, 2024, a meeting was held with the Public Health Department of Romagna’s Local Healthcare Authority to initiate a new study on the uptake of recommended vaccines in individuals with diabetes. This study will assess determinants of vaccine adherence, including proximity to public health clinics (“Ambulatori dell’igiene pubblica”) and community health centers (“Case della comunità”), as well as characteristics of family doctors’ primary care networks (“Nuclei di cure primarie”).
Brief description of the activities and of the intermediate results
- October–December 2024: A research protocol titled “Vaccination Coverage, Determinants of Adherence, and Health Outcomes in Diabetic Patients: A Retrospective Study within the Romagna Health Authority” has been developed. It outlines a comprehensive framework to improve the calculation of vaccination coverage in diabetic patients through advanced cohort identification algorithms and administrative data linkage, aligned with regional and national guidelines. Particular attention is given to the role of organizational determinants of vaccine adherence, such as healthcare delivery models and primary care structures.
- December 2024: The protocol has been submitted to the Ethics Committee of Romagna for review and approval.
Brief description of the activities and of the intermediate results
- Coordination of supplementary documentation for the retrospective study COVER-D on vaccine adherence and health outcomes in patients with diabetes, in collaboration with the Local Healthcare Authority (LHA) of Romagna.
- Participation in the Ethics Committee process: positive opinion issued by the CMS Board on January 21st, 2025, subject to Data Protection Impact Assessment (DPIA).
- Final approval of the study by the Ethics Committee on January 23rd, 2025.
- Preparation and negotiation of the DPIA in collaboration with the Legal and General Affairs Unit of Romagna’s LHA; as of March 31st, 2025, the DPIA was under review by the company’s Data Protection Officer (DPO).
- Support in the clarification of roles and data ownership between the University of Bologna and the LHA, to clarify that a new study-specific research agreement was not required.
- Close coordination with local stakeholders to align administrative procedures and overcome internal barriers to data access.
- Drafting of a simplified Case Report Form (CRF) to be used as a blueprint for the upcoming data extraction and database reconstruction phase.
- Development of a narrative review and operational model on PROMs in older adults with type 2 diabetes, promoting inter-Spoke collaboration and cross-disciplinary integration with clinical psychology and related fields
- Preparation and submission of proposals for a roundtable and symposium on clinical psychology of aging and the role of PROMs in type 2 diabetes, for upcoming scientific conferences
- Lenzi, J., Messina, R., Rosa, S., Iommi, M., Rucci, P., Pia Fantini, M., & Di Bartolo, P. (2024). A multi-state analysis of disease trajectories and mental health transitions in patients with type 2 diabetes: A population-based retrospective cohort study utilizing health administrative data. Diabetes research and clinical practice, 209, 111561. https://doi.org/10.1016/j.diabres.2024.111561
- Messina, R., Mezuk, B., Rosa, S., Iommi, M., Fantini, M. P., Lenzi, J., & Di Bartolo, P. (2024). Age of type 2 diabetes onset as a risk factor for dementia: A 13-year retrospective cohort study. Diabetes research and clinical practice, 213, 111760. https://doi.org/10.1016/j.diabres.2024.111760
- Messina, R., Lenzi, J., Rosa, S., Fantini, M. P., & Di Bartolo, P (2024). Clinical Health Psychology Perspectives in Diabetes Care: A Retrospective Cohort Study Examining the Role of Depression in Adherence to Visits and Examinations in Type 2 Diabetes Management. Healthcare, 12, 1942. https://doi.org/10.3390/healthcare12191942