Self-care and its assessment in the patient-caregiver dyad in Parkinson's disease: a mixed-method study protocol.

introductionParkinson'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. METHODS AND ANALYSIS: 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. ETHICS AND DISSEMINATION: 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. TRIAL REGISTRATION NUMBER: NCT06953050 (clinicaltrials.gov).