Gustafson David H, McTavish Fiona, Gustafson David H, Mahoney Jane E, Johnson Roberta A, Lee John D, Quanbeck Andrew, Atwood Amy K, Isham Andrew, Veeramani Raj, Clemson Lindy, Shah Dhavan
Center for Health Enhancement Systems Studies, University of Wisconsin-Madison, Madison, WI, 53706, USA.
Division of Geriatrics, Department of Medicine, University of Wisconsin School of Medicine and Public Health and Executive Director, Wisconsin Institute for Health Aging, Madison, WI, 53792, USA.
Trials. 2015 Apr 25;16:191. doi: 10.1186/s13063-015-0713-2.
This study investigates the use of an information and communication technology (Elder Tree) designed for older adults and their informal caregivers to improve older adult quality of life and address challenges older adults face in maintaining their independence (for example, loneliness and isolation, falling, managing medications, driving and transportation).
METHODS/DESIGN: This study, an unblinded randomized controlled trial, will evaluate the effectiveness and cost of Elder Tree. Older adults who are at risk for losing their independence - along with their informal caregivers, if they name them - are randomized to two groups. The intervention group has access to their usual sources of information and communication as well as to Elder Tree for 18 months while the control group uses only their usual sources of information and communication. The primary outcome of the study is older adult quality of life. Secondary outcomes are cost per Quality-Adjusted Life Year and the impact of the technology on independence, loneliness, falls, medication management, driving and transportation, and caregiver appraisal and mastery. We will also examine the mediating effect of self-determination theory. We will evaluate the effectiveness of Elder Tree by comparing intervention- and control-group participants at baseline and months 6, 12, and 18. We will use mixed-effect models to evaluate the primary and secondary outcomes, where pretest score functions as a covariate, treatment condition is a between-subjects factor, and the multivariate outcome reflects scores for a given assessment at the three time points. Separate analyses will be conducted for each outcome. Cost per Quality-Adjusted Life Year will be compared between the intervention and control groups. Additional analyses will examine the mediating effect of self-determination theory on each outcome.
Elder Tree is a multifaceted intervention, making it a challenge to assess which services or combinations of services account for outcomes in which subsets of older adults. If Elder Tree can improve quality of life and reduce healthcare costs among older adults, it could suggest a promising way to ease the burden that advancing age can place on older adults, their families, and the healthcare system.
ClinicalTrials.gov NCT02128789 . Registered on 26 March 2014.
本研究调查一种为老年人及其非正式照护者设计的信息通信技术（老年树）的使用情况，以改善老年人的生活质量，并应对老年人在维持独立生活方面面临的挑战（例如，孤独与孤立、跌倒、药物管理、驾驶与交通）。
方法/设计：本研究为一项非盲随机对照试验，将评估老年树的有效性和成本。有失去独立生活风险的老年人——以及他们指定的非正式照护者（如果有的话）——被随机分为两组。干预组可使用其常规的信息和通信来源以及老年树，为期18个月，而对照组仅使用其常规的信息和通信来源。本研究的主要结局是老年人的生活质量。次要结局包括每质量调整生命年的成本以及该技术对独立性、孤独感、跌倒、药物管理、驾驶与交通的影响，以及照护者的评价和掌控感。我们还将检验自我决定理论的中介作用。我们将通过比较干预组和对照组参与者在基线以及第6、12和18个月时的情况来评估老年树的有效性。我们将使用混合效应模型来评估主要和次要结局，其中预测试分数作为协变量，治疗条件是组间因素，多变量结局反映三个时间点给定评估的分数。将对每个结局进行单独分析。将比较干预组和对照组每质量调整生命年的成本。额外的分析将检验自我决定理论对每个结局的中介作用。
老年树是一项多方面的干预措施，要评估哪些服务或服务组合导致了哪些老年人群体的结局是一项挑战。如果老年树能够改善老年人的生活质量并降低医疗保健成本，那么它可能为减轻老龄化给老年人、其家庭和医疗保健系统带来的负担提供一种有前景的方法。
ClinicalTrials.gov NCT02128789。于2014年3月26日注册。
