Long-term brain health profiles following exposure to repetitive head impacts and/or concussions in contact sports are a public health focus and the subject of a national debate. The true prevalence rates of mild cognitive impairment (MCI) or neurobehavioural dysregulation are unknown in the nearly 20 000 current/living former professional football players. Here, we describe the procedures and methodology of the prevalence study of cognitive function in former professional football players from the Brain Health Initiative at the University of Pittsburgh. The objective is to define the prevalence of normal cognitive function versus neurodegeneration in former professional football players through clinical, neuroimaging and biomarker assessments.

Participants include former professional football players aged 29–59 years at study onset who played a minimum of three professional football games in three professional seasons and non-exposed controls. Participants are recruited by two mechanisms, a random and non-random sample. The full study protocol includes a 3–4-day, multidomain assessment (eg, neurological, neurocognitive, psychiatric, sleep, vestibular, orthopaedic and cardiovascular) for neurodegenerative disease and overall health and function, including MRI, positron emission tomography scans, analysis of blood plasma and cerebrospinal fluid, neurocognitive assessments, applanation tonometry, overnight sleep study and informant interview. A multidisciplinary clinical panel conducts a blinded diagnostic consensus conference to adjudicate the presence of MCI and/or traumatic encephalopathy syndrome, which serve as the study’s primary and secondary outcomes, respectively. Point prevalence of these for both the exposed and unexposed cohorts will be calculated as the primary statistical analysis.

The University of Pittsburgh Institutional Review Board approved the study prior to recruiting human subjects (protocol numbers STUDY19010008: sIRB - Brain Health Initiative (Part 1) and STUDY19030211: sIRB - Brain Health Initiative (Part 2)). The results will be disseminated in peer-reviewed journals and as presentations at national and international scientific conferences.

Parkinson’s disease (PD) is a chronic neurodegenerative condition that affects approximately 10 million people worldwide. As the second most common neurodegenerative disease, its prevalence is expected to double in the next 30 years. PD is characterised by both motor and non-motor symptoms that significantly impact patients’ quality of life. The disease leads to physical disabilities and can strain the social and emotional well-being of patients and caregivers. While pharmacological and surgical treatments are essential, non-pharmacological approaches, including self-care strategies, play a critical role in managing the disease. This study protocol aims to describe methodological steps required to explore the self-care behaviours of patients with PD and their caregivers, with a particular focus on the dimensions of self-care maintenance, monitoring and management.

This mixed-method study will involve dyads of patients with PD and their caregivers. Participants will be recruited from the PD and Movement Disorders Centre of the "Azienda Socio Sanitaria Territoriale (ASST) Gaetano Pini-Centro Traumatologico Ortopedico (CTO)". Validated questionnaires, such as the WHOQOL-Bref, the version 2 Self-Care of Chronic Illness Inventory, and the Caregiver Self-Efficacy in Contributing to Self-Care Scale, will be administered. The study will also include semistructured interviews to collect qualitative data on patients’ and caregivers’ perceptions of self-care. A non-probabilistic convenience sampling method will be employed, encompassing both patients at any stage of disease and their primary caregivers. The estimated sample size is 311 dyads, calculated to provide a 5% margin of error.

The study has been approved by the Lombardia 3 ethics committee (identification (ID) study 5732 12.03.2025 P bis). All participants will sign a written informed consent document. Ethical considerations include ensuring participant confidentiality, voluntary participation and the right to withdraw at any time without consequence. The study results will be disseminated through national and international conferences and published in clinical research journals to contribute to the broader understanding of self-care in the management of PD.

NCT06953050 (clinicaltrials.gov).

Transitions of care (TOC) between hospital, ambulatory and home settings for high-risk adults with chronic diseases are complex, costly and often result in poor health outcomes. Suboptimal care transitions lead to medication errors, non-adherence, decreased self-management skills and inadequate follow-up, all of which contribute to readmissions or emergency department visits. The Transitional Care Model aims to address these challenges through patient-centred, in-home interventions. We propose to implement and evaluate TELE-TOC: Telehealth Education Leveraging Electronic Transitions Of Care for Chronic Obstructive Pulmonary Disease (COPD) patients. This study will evaluate the added value of a virtual, pharmacy-based intervention integrated into an existing COPD TOC program within a single healthcare system.

Informed by the Proctor Framework implementation, service and health outcome domains, we will conduct a randomised controlled trial comparing the addition of at-home pharmacy team-based virtual visits to the standard of care (ie, our existing COPD TOC programme). Adult patients hospitalised for a COPD exacerbation will be randomised to receive the standard COPD TOC programme alone or the standard programme plus TELE-TOC virtual at-home pharmacy visits. We will use a pragmatic type II hybrid effectiveness-implementation trial. The primary effectiveness outcome is inhaler technique at 30 days postdischarge, and the primary implementation outcome is the proportion of patients receiving the intervention. Intention-to-treat analysis will be applied to all outcomes with ² and logistic regression models adjusting for demographic factors. Treatment effects through 30 days will be assessed with generalised estimating equations and generalised linear mixed models.

This study, the waiver of consent and the opt-out flyer were approved by the University of Chicago Institutional Review Board (23–0934). Dissemination of the findings is planned for up to 4 years of completion of the study to local, regional and national conferences and peer-reviewed journals.

NCT05897125.

To identify distinct sleep quality patterns among patients with heart failure (HF) using a person-centred approach and explore demographic and clinical predictors of these patterns.

Secondary analysis of baseline cross-sectional data from the MOTIVATE-HF (MOTIVATional intErviewing to improve self-care in Heart Failure patients) randomised controlled trial. Latent class analysis (LCA) was applied to Pittsburgh Sleep Quality Index (PSQI) component scores to identify distinct subgroups of patients. Demographic, clinical and psychological variables were examined as potential predictors of cluster membership.

Three healthcare settings in Italy: hospital, outpatient and community-based care.

510 adult patients diagnosed with HF (New York Heart Association (NYHA) class II–IV) with poor self-care were included. Patients with severe cognitive impairment or recent myocardial infarction were excluded.

Primary outcome: Sleep quality, measured using the PSQI, analysed through LCA to identify sleep disturbance clusters. Secondary outcomes included demographic and clinical characteristics predicting cluster membership.

The mean age was 72.4 years (SD=12.3), with most participants married or partnered (62%) and retired or unemployed (83.9%). Mild comorbidities were present in 53.3% of the sample (mean Charlson Comorbidity Index (CCI)=2.91, SD=1.98), and 61.4% were classified in NYHA class II. Three sleep quality clusters emerged: (1) adequate sleep duration but disturbed sleep and daytime dysfunction (46.1%); (2) severe sleep problems with low use of sleeping medications (25.3%); and (3) minor sleep problems with mild disturbances (28.6%). Patients in Cluster 1 were older (mean age=73.3 years), had lower physical and mental quality of life (Short-Form 12 Physical Component Summary=33.66; Mental Component Summary=42.65), and higher anxiety (Hospital Anxiety and Depression Scale-A=8.82). Patients in Cluster 2 had more severe comorbidities (CCI=3.55), poorer cognitive function (Montreal Cognitive Assessment (MoCA)=21.5) and lower ejection fraction (mean=40%). Patients in Cluster 3 were younger (mean age=68.2 years), had better cardiac function (ejection fraction=46.6%), better cognitive status (MoCA=24.5) and the highest quality of life (Kansas City Cardiomyopathy Questionnaire=63.1).

Patients with HF exhibit heterogeneous sleep quality patterns with specific clinical and psychological profiles. These findings highlight the need for personalised interventions, systematic sleep assessments and the integration of cardiac rehabilitation strategies into standard HF care.

NCT02894502.