BPSDiary study protocol: a multi-center randomized controlled trial to compare the efficacy of a BPSD diary vs. standard care in reducing caregiver's burden.

Autor:	Pozzi FE; Neurology Department, Fondazione IRCCS San Gerardo dei Tintori, Monza, Italy.; Milan Center for Neuroscience (NeuroMI), University of Milano-Bicocca, Milan, Italy.; School of Medicine and Surgery, University of Milano-Bicocca, Milan, Italy., Calì L; School of Medicine and Surgery, University of Milano-Bicocca, Milan, Italy., D'Antonio F; Human Neuroscience Department, Sapienza Università di Roma, Rome, Italy.; Neuropsychology Unit, IRCCS Fondazione Santa Lucia, Rome, Italy., Altomare AI; Psychiatry Unit, Department of Health Sciences, University of Florence, Florence, Italy., Sepe Monti M; Human Neuroscience Department, Sapienza Università di Roma, Rome, Italy., Panigutti M; Human Neuroscience Department, Sapienza Università di Roma, Rome, Italy., Di Crosta A; Department of Medicine and Aging Sciences, University G. d'Annunzio of Chieti-Pescara, Chieti, Italy., Palumbo R; Department of Medicine and Aging Sciences, University G. d'Annunzio of Chieti-Pescara, Chieti, Italy., Bonanni L; Department of Medicine and Aging Sciences, University G. d'Annunzio of Chieti-Pescara, Chieti, Italy., Carlucci V; Neurology Unit, Department of Neuroscience, University of Padova, Padua, Italy., Bussè C; Neurology Unit, Department of Neuroscience, University of Padova, Padua, Italy., Cagning A; Neurology Unit, Department of Neuroscience, University of Padova, Padua, Italy., Urso D; Center for Neurodegenerative Diseases and the Aging Brain, Department of Clinical Research in Neurology, University of Bari Aldo Moro, 'Pia Fondazione Cardinale G. Panico', Lecce, Italy., Vilella D; Center for Neurodegenerative Diseases and the Aging Brain, Department of Clinical Research in Neurology, University of Bari Aldo Moro, 'Pia Fondazione Cardinale G. Panico', Lecce, Italy., Logroscino G; Center for Neurodegenerative Diseases and the Aging Brain, Department of Clinical Research in Neurology, University of Bari Aldo Moro, 'Pia Fondazione Cardinale G. Panico', Lecce, Italy., Alberoni M; Neurology Department, IRCCS Fondazione Don Carlo Gnocchi, Milan, Italy., Bellinvia A; Neurology Department, IRCCS Fondazione Don Carlo Gnocchi, Milan, Italy., Farina E; Neurology Department, IRCCS Fondazione Don Carlo Gnocchi, Milan, Italy., de Rino F; Neurology Department, MultiMedica Castellanza, Castellanza, Italy., Gavazzi A; Neurology Department, MultiMedica Castellanza, Castellanza, Italy., Zuffi M; Neurology Department, MultiMedica Castellanza, Castellanza, Italy., Bruno G; Human Neuroscience Department, Sapienza Università di Roma, Rome, Italy., Bessi V; Department of Neuroscience, Psychology, Drug Research and Child Health, University of Florence, Florence, Italy.; Research and Innovation Centre for Dementia-CRIDEM, AOU Careggi, Florence, Italy., Cotta Ramusino M; Unit of Behavioral Neurology Fondazione IRCCS Mondino, and University of Pavia, Pavia, Italy., Perini G; Unit of Behavioral Neurology Fondazione IRCCS Mondino, and University of Pavia, Pavia, Italy., Costa A; Unit of Behavioral Neurology Fondazione IRCCS Mondino, and University of Pavia, Pavia, Italy., Ferrarese C; Neurology Department, Fondazione IRCCS San Gerardo dei Tintori, Monza, Italy.; Milan Center for Neuroscience (NeuroMI), University of Milano-Bicocca, Milan, Italy.; School of Medicine and Surgery, University of Milano-Bicocca, Milan, Italy., Appollonio I; Neurology Department, Fondazione IRCCS San Gerardo dei Tintori, Monza, Italy.; Milan Center for Neuroscience (NeuroMI), University of Milano-Bicocca, Milan, Italy.; School of Medicine and Surgery, University of Milano-Bicocca, Milan, Italy., Tremolizzo L; Neurology Department, Fondazione IRCCS San Gerardo dei Tintori, Monza, Italy.; Milan Center for Neuroscience (NeuroMI), University of Milano-Bicocca, Milan, Italy.; School of Medicine and Surgery, University of Milano-Bicocca, Milan, Italy.
Jazyk:	angličtina
Zdroj:	Frontiers in dementia [Front Dement] 2023 Dec 18; Vol. 2, pp. 1301280. Date of Electronic Publication: 2023 Dec 18 (Print Publication: 2023).
DOI:	10.3389/frdem.2023.1301280
Abstrakt:	Behavioral and Psychological Symptoms of Dementia (BPSD) are a heterogeneous set of psychological and behavioral abnormalities seen in persons with dementia (PwD), significantly impacting their quality of life and that of their caregivers. Current assessment tools, such as the Neuropsychiatric Inventory (NPI), are limited by recall bias and lack of direct observation. This study aims to overcome this limitation by making caregiver reports more objective through the use of a novel instrument, referred to as the BPSDiary. This randomized controlled trial will involve 300 caregiver-PwD dyads. The objective is to evaluate whether the use of the BPSDiary could significantly reduce caregiver burden, assessed using the Zarit Burden Interview (ZBI), compared to usual care. The study will include adult PwD, caregivers living with or close to the patient, and BPSD related to the HIDA (hyperactivity, impulsivity, irritability, disinhibition, aggression, agitation) domain. Caregivers randomized to the intervention arm will use the BPSDiary to record specific BPSD, including insomnia, agitation/anxiety, aggression, purposeless motor behavior, and delusions/hallucinations, registering time of onset, severity, and potential triggers. The primary outcome will be the change in ZBI scores at 3 months, with secondary outcomes including changes in NPI scores, olanzapine equivalents, NPI-distress scores related to specific BPSD domains, and caregiver and physician satisfaction. The study will be conducted in 9 Italian centers, representing diverse geographic and sociocultural contexts. While potential limitations include the relatively short observation period and the focus on specific BPSD disturbances, the BPSDiary could provide physicians with objective data to tailor appropriate non-pharmacological and pharmacological interventions. Additionally, it may empower caregivers by encouraging reflection on BPSD triggers, with the potential to improve the quality of life for both PwD and their caregivers. Trial Registry: NCT05977855. Competing Interests: The authors declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. The author(s) declared that they were an editorial board member of Frontiers, at the time of submission. This had no impact on the peer review process and the final decision. (Copyright © 2023 Pozzi, Calì, D'Antonio, Altomare, Sepe Monti, Panigutti, Di Crosta, Palumbo, Bonanni, Carlucci, Bussè, Cagning, Urso, Vilella, Logroscino, Alberoni, Bellinvia, Farina, de Rino, Gavazzi, Zuffi, Bruno, Bessi, Cotta Ramusino, Perini, Costa, Ferrarese, Appollonio and Tremolizzo.)
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu