Pozzi Federico Emanuele, Calì Luisa, D'Antonio Fabrizia, Altomare Arianna Ida, Sepe Monti Micaela, Panigutti Massimiliano, Di Crosta Adolfo, Palumbo Rocco, Bonanni Laura, Carlucci Valentina, Bussè Cinzia, Cagning Annachiara, Urso Daniele, Vilella Davide, Logroscino Giancarlo, Alberoni Margherita, Bellinvia Angelo, Farina Elisabetta, de Rino Francesca, Gavazzi Armando, Zuffi Marta, Bruno Giuseppe, Bessi Valentina, Cotta Ramusino Matteo, Perini Giulia, Costa Alfredo, Ferrarese Carlo, Appollonio Ildebrando, Tremolizzo Lucio
Neurology Department, Fondazione IRCCS San Gerardo dei Tintori, Monza, Italy.
Milan Center for Neuroscience (NeuroMI), University of Milano-Bicocca, Milan, Italy.
Front Dement. 2023 Dec 18;2:1301280. doi: 10.3389/frdem.2023.1301280. eCollection 2023.
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.
NCT05977855.
痴呆的行为和心理症状（BPSD）是痴呆患者（PwD）中出现的一组异质性心理和行为异常，对他们及其照顾者的生活质量有重大影响。当前的评估工具，如神经精神科问卷（NPI），受到回忆偏差和缺乏直接观察的限制。本研究旨在通过使用一种称为BPSD日记的新型工具，使照顾者报告更客观，从而克服这一限制。这项随机对照试验将涉及300对照顾者-痴呆患者二元组。目的是评估与常规护理相比，使用BPSD日记是否能显著减轻照顾者负担，使用 Zarit 负担访谈（ZBI）进行评估。该研究将纳入成年痴呆患者、与患者同住或住得很近的照顾者，以及与HIDA（多动、冲动、易怒、脱抑制、攻击、激越）领域相关的BPSD。随机分配到干预组的照顾者将使用BPSD日记记录特定的BPSD，包括失眠、激越/焦虑、攻击、无目的运动行为以及妄想/幻觉，记录发作时间、严重程度和潜在触发因素。主要结局将是3个月时ZBI评分的变化，次要结局包括NPI评分的变化、奥氮平等效剂量、与特定BPSD领域相关的NPI-痛苦评分，以及照顾者和医生的满意度。该研究将在9个意大利中心进行，代表不同的地理和社会文化背景。虽然潜在的局限性包括观察期相对较短以及关注特定的BPSD障碍，但BPSD日记可以为医生提供客观数据，以制定适当的非药物和药物干预措施。此外，它可能通过鼓励照顾者思考BPSD的触发因素来增强他们的能力，有可能改善痴呆患者及其照顾者的生活质量。
NCT05977855。
