SmartCare: Innovations in Caregiving Interventions

描述(申请人提供)：多项研究表明，为患有慢性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、整体健康状况不佳以及总体死亡率增加。患有原发恶性脑瘤(PMBT)的家庭照顾者面临着肿瘤和神经退行性疾病，因此预后不良的风险尤其大。旨在改善照顾者心理健康的多种照顾者干预措施已被评估，但荟萃分析未能证明持续的强大效应大小。由于研究表明抑郁症状会干扰一个人参与干预并从干预中受益的能力，我们假设目前的照顾者干预措施没有显示出大的效果，因为它们没有解决先前存在的抑郁症状水平。该项目的长期目标是确定提供干预措施的最有效方式，以改善家庭照料者的心理和身体健康。这项多地点三组随机对照试验的具体目的是：1)比较a)在基于需要的照顾者干预(SmartCare(C))之前对抑郁症状(Beat The Blues)进行干预(SmartCare(C))与b)SmartCare(C)单独与c)加强照顾者(CAU+)在改善照顾者心理和身体健康方面的有效性，以及2)比较Beats Blues与CAU+在改善受试者短期心理和身体健康方面的有效性。我们还计划探索1)在接受SmartCare(C)或SmartCare(C)之前单独接受殴打Blues对心理和身体健康造成的任何变化是否在基线后10个月保持不变；2)击败Blues+SmartCare(C)(与单独接受SmartCare(C))对4个月和6个月心理和身体反应的影响是否通过0至2个月抑郁症状的变化来调节。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学诊所招聘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研究随着时间的推移，群体分配与心理和生理结果的关系。这项拟议的研究涉及NCI和NINR为提高患者及其家人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以及采用、调整和产生新技术的重视。就潜在的社会和经济影响而言，该项目的意义重大。基于网络和电话的干预提供允许轻松翻译，如果假设得到支持，这项试验可能从根本上改变护理者干预的提供方式。

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.