Jackson Jeanne, Mandel Deborah, Blanchard Jeanine, Carlson Mike, Cherry Barbara, Azen Stanley, Chou Chih-Ping, Jordan-Marsh Maryalice, Forman Todd, White Brett, Granger Douglas, Knight Bob, Clark Florence
Division of Occupational Science and Occupational Therapy, University of Southern California, Los Angeles 90089-9003, USA.
Clin Trials. 2009 Feb;6(1):90-101. doi: 10.1177/1740774508101191.
Community-dwelling older adults are at risk for declines in physical health, cognition, and psychosocial well-being. However, their enactment of active and health-promoting lifestyles can reduce such declines.
The purpose of this article is to describe the USC Well Elderly II study, a randomized clinical trial designed to test the effectiveness of a healthy lifestyle program for elders, and document how various methodological challenges were addressed during the course of the trial.
In the study, 460 ethnically diverse elders recruited from a variety of sites in the urban Los Angeles area were enrolled in a randomized experiment involving a crossover design component. Within either the first or second 6-month phase of their study involvement, each elder received a lifestyle intervention designed to improve a variety of aging outcomes. At 4-5 time points over an 18-24 month interval, the research participants were assessed on measures of healthy activity, coping, social support, perceived control, stress-related biomarkers, perceived physical health, psychosocial well-being, and cognitive functioning to test the effectiveness of the intervention and document the process mechanisms responsible for its effects.
The study protocol was successfully implemented, including the enrollment of study sites, the recruitment of 460 older adults, administration of the intervention, adherence to the plan for assessment, and establishment of a large computerized data base.
Methodological challenges were encountered in the areas of site recruitment, participant recruitment, testing, and intervention delivery.
The completion of clinical trials involving elders from numerous local sites requires careful oversight and anticipation of threats to the study design that stem from: (a) social situations that are particular to specific study sites; and (b) physical, functional, and social challenges pertaining to the elder population.
社区居住的老年人面临身体健康、认知能力和心理社会幸福感下降的风险。然而，他们践行积极的、促进健康的生活方式可以减少此类下降。
本文旨在描述南加州大学老年健康II研究，这是一项随机临床试验，旨在测试一项针对老年人的健康生活方式项目的有效性，并记录在试验过程中如何应对各种方法学挑战。
在该研究中，从洛杉矶市区多个地点招募的460名不同种族的老年人参与了一项包含交叉设计部分的随机实验。在他们参与研究的前6个月或后6个月阶段，每位老年人都接受了旨在改善多种衰老结果的生活方式干预。在18至24个月的间隔内的4至5个时间点，对研究参与者进行健康活动、应对方式、社会支持、感知控制、应激相关生物标志物、感知身体健康、心理社会幸福感和认知功能等方面的评估，以测试干预的有效性并记录其产生效果的过程机制。
研究方案成功实施，包括研究地点的招募、460名老年人的招募、干预措施的实施、对评估计划的遵守以及大型计算机数据库的建立。
在研究地点招募、参与者招募、测试和干预实施等方面遇到了方法学挑战。
完成涉及众多当地地点老年人参与的临床试验需要仔细监督，并预期来自以下方面对研究设计的威胁：(a)特定研究地点特有的社会情况；(b)与老年人群体相关的身体、功能和社会挑战。
