Italian National Research Center on Aging, Ancona, Italy.
Trials. 2013 May 28;14:155. doi: 10.1186/1745-6215-14-155.
The epidemic of Alzheimer's disease (AD) represents a significant challenge for the health care and social service systems of many developed countries. AD affects both patients and family caregivers, on whom the main burden of care falls, putting them at higher risk of stress, anxiety, mortality and lower quality of life. Evidence remains controversial concerning the effectiveness of providing support to caregivers of AD patients, through case management, counseling, training, technological devices and the integration of existing care services. The main objectives of the UP-TECH project are: 1) to reduce the care burden of family caregivers of AD patients; and 2) to maintain AD patients at home.
METHODS/DESIGN: A total of 450 dyads comprising AD patients and their caregivers in five health districts of the Marche region, Italy, will be randomized into three study arms. Participants in the first study arm will receive comprehensive care and support from a case manager (an ad hoc trained social worker) (UP group). Subjects in the second study arm will be similarly supported by a case manager, but in addition will receive a technological toolkit (UP-TECH group). Participants in the control arm will only receive brochures regarding available services. All subjects will be visited at home by a trained nurse who will assess them using a standardized questionnaire at enrollment (M0), 6 months (M6) and 12 months (M12). Follow-up telephone interviews are scheduled at 24 months (M24). The primary outcomes are: 1) caregiver burden, measured using the Caregiver Burden Inventory (CBI); and 2) the actual number of days spent at home during the study period, defined as the number of days free from institutionalizations, hospitalizations and stays in an observation unit of an emergency room.
The UP-TECH project protocol integrates previous evidence on the effectiveness of strategies in dementia care, that is, the use of case management, new technologies, nurse home visits and efforts toward the integration of existing services in an ambitious holistic design. The analysis of different interventions is expected to provide sound evidence of the effectiveness and cost of programs supporting AD patients in the community.
ClinicalTrials.gov: NCT01700556.
阿尔茨海默病（AD）的流行给许多发达国家的医疗保健和社会服务系统带来了重大挑战。AD 不仅影响患者，还影响承担主要照顾责任的患者家属，使他们面临更高的压力、焦虑、死亡和更低生活质量的风险。为 AD 患者的照顾者提供支持，通过个案管理、咨询、培训、技术设备和整合现有护理服务，其有效性的证据仍然存在争议。UP-TECH 项目的主要目标是：1）减轻 AD 患者家属的照顾负担；2）使 AD 患者在家中得到维持。
方法/设计：共有来自意大利马尔凯地区五个卫生区的 450 对 AD 患者及其照顾者被随机分为三组。第一组研究对象将接受个案经理（经过专门培训的社会工作者）提供的综合护理和支持（UP 组）。第二组研究对象将同样接受个案经理的支持，但除此之外，他们还将获得一套技术工具包（UP-TECH 组）。对照组的参与者将仅收到有关现有服务的小册子。所有参与者将由经过培训的护士家访，护士将使用标准化问卷在入组时（M0）、6 个月（M6）和 12 个月（M12）对他们进行评估。在 24 个月（M24）时安排了随访电话访谈。主要结果是：1）照顾者负担，使用照顾者负担量表（CBI）测量；2）在研究期间实际在家中的天数，定义为无机构化、住院和在急诊观察室留观的天数。
UP-TECH 项目方案整合了痴呆症护理策略的有效性证据，即使用个案管理、新技术、护士家访以及努力整合现有服务的全面设计。对不同干预措施的分析有望为支持社区中的 AD 患者的项目的有效性和成本提供可靠证据。
ClinicalTrials.gov：NCT01700556。
