痴呆症的行为和心理症状(BPSD)是在痴呆症(PwD)患者中发现的一组异质性的心理和行为异常,显著影响他们和照顾者的生活质量。当前的评估工具,如神经精神量表(NPI),受到召回偏见和缺乏直接观察的限制。这项研究旨在克服这一限制,通过使用一种新型仪器,使护理人员的报告更加客观,被称为BPSDiary。这项随机对照试验将涉及300名护理人员-PwDdyads。目的是评估BPSDiary的使用是否可以显着减轻护理人员的负担,使用Zarit负担访谈(ZBI)进行评估,与通常的护理相比。这项研究将包括成人PwD,与患者生活在一起或在患者附近的护理人员,和BPSD与HIDA(多动症,冲动,烦躁,去抑制,侵略,搅动)领域。随机分配到干预组的护理人员将使用BPSDiary记录特定的BPSD,包括失眠,激动/焦虑,侵略,无目的的运动行为,和妄想/幻觉,登记发病时间,严重程度,和潜在的触发因素。主要结果将是3个月时ZBI评分的变化,次要结果包括NPI评分的变化,奥氮平等效物,与特定BPSD域相关的NPI-遇险分数,以及护理人员和医生的满意度。这项研究将在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相对较短的观察期和对特定BPSD干扰的关注,BPSDiary可以为医生提供客观数据,以定制适当的非药物和药物干预措施.此外,它可以通过鼓励对BPSD触发因素的反思来赋予护理人员权力,有可能改善PwD及其护理人员的生活质量。
■NCT05977855。
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.
UNASSIGNED: NCT05977855.