SmartCare: Innovations in Caregiving Interventions

描述（由申请人提供）：多项研究表明，为患有慢性疾病的家庭成员提供护理的心理和身体后果可能包括焦虑，抑郁症状，负担，免疫功能改变，整体健康状况不佳和整体死亡率增加。患有原发性恶性脑肿瘤（PMBT）的人的家庭照顾者特别容易出现不良结局，因为他们面临肿瘤学和神经退行性问题。旨在改善护理人员心理健康的多种护理人员干预措施已经过评估，但荟萃分析未能证明一致的强效应量。由于研究表明，抑郁症状干扰一个人的参与和受益于干预的能力，我们假设，目前的护理干预措施没有表现出大的效果大小，因为他们没有解决预先存在的抑郁症状的水平。该项目的长期目标是确定最有效的干预方法，以改善家庭照顾者的身心健康。这项多中心三组随机对照试验的具体目的是：1）比较a）抑郁症状干预的有效性在基于需求的护理人员干预之前交付（击败蓝调）（SmartCare（c））对比B）SmartCare（c）单独对比c）常规加强护理（CAU+），以改善护理人员的心理和身体健康，以及2）比较战胜忧郁与CAU+在改善受试者短期心理和身体健康方面的疗效。我们还计划探索1）在SmartCare（c）或单独SmartCare（c）之前接受Beating the Blues（击败蓝调）治疗所导致的心理和身体健康变化是否在基线后10个月保持不变，以及2）Beating the Blues + SmartCare（击败蓝调+ SmartCare）（c）的效果是否（与单独使用SmartCare（c）相比）对4个月和6个月心理和身体反应的影响是由0至2个月的抑郁症状变化介导的。我们将从匹兹堡大学癌症研究所和MD安德森癌症中心神经肿瘤诊所招募210名护理者/护理接受者。使用一般线性混合模型的重复测量建模将调查随时间推移的组分配与心理和身体结果的关系。这项拟议的研究解决了NCI和NINR为提高患者及其家属的生活质量而设定的研究优先事项，以及NINR对整合生物行为科学和采用，适应和产生新技术的重视。就其潜在的社会和经济影响而言，该项目意义重大。基于网络和电话的干预交付允许轻松翻译，如果假设得到支持，这项试验可能会从根本上改变护理人员干预的交付方式。

DESCRIPTION (provided by applicant): Multiple studies have shown that the psychological and physical consequences of providing care to a family member with a chronic illness can include anxiety, depressive symptoms, burden, altered immune function, poor overall health, and increased overall mortality. Family caregivers of persons with a primary malignant brain tumor (PMBT) are at particular risk for poor outcomes as they face both oncologic and neurodegenerative issues. Multiple caregiver interventions aimed at improving caregivers' psychological health have been evaluated, yet meta-analyses fail to demonstrate consistently strong effect sizes. As a result of research suggesting that depressive symptoms interfere with a person's ability to engage in and benefit from intervention, we hypothesize that current caregiver interventions have not demonstrated large effect sizes because they have not addressed pre-existing levels of depressive symptoms. The long term goals of the project are to identify the most effective ways to deliver interventions to improve the psychological and physical health of family caregivers. The specific aims of this multi-site three arm randomized controlled trial are to: 1) Compare the efficacy of a) an intervention for depressive symptoms (Beating the Blues) delivered prior to a needs-based caregiver intervention (SmartCare(c)) versus b) SmartCare(c) alone versus c) enhanced care as usual (CAU+) in improving caregivers' psychological and physical health and 2) Compare the efficacy of Beating the Blues versus CAU+ in improving subjects' short- term psychological and physical health. We also plan to explore 1) whether any changes in psychological and physical health resulting from receiving Beating the Blues prior to SmartCare(c) or SmartCare(c) alone are maintained at 10-months after baseline and 2) whether the effect of Beating the Blues + SmartCare(c) (vs. SmartCare(c) alone) on 4- and 6-month psychological and physical responses is mediated by 0- to 2-month changes in depressive symptoms. We will be recruiting 210 caregiver/care recipient dyads from the University of Pittsburgh Cancer Institute and MD Anderson Cancer Center neuro-oncology clinics. Repeated measures modeling using general linear mixed models will investigate the relationship of group assignment with psychological and physical outcomes over time. The proposed study addresses research priorities set by both NCI and NINR to improve the quality of life of patients and their families and NINR's emphasis on integrating bio-behavioral science and adopting, adapting and generating new technologies. The significance of the project is great in terms of its potential societal and economic impact. The web-based and telephone intervention delivery allows for easy translation and should the hypotheses be supported, this trial could fundamentally change how caregiver interventions are delivered.