Suls Jerry, Friel Ciarán P, Butler Mark, Duer-Hefele Joan, Robles Patrick L, Vicari Frank, Chandereng Thevaa, Cheung Ying Kuen Ken, Davidson Karina W
Institute for Health System Science Feinstein Institutes for Medical Research Northwell Health 130 East 59th Street, Suite 14C, New York, NY, 10022, USA.
Contemp Clin Trials Commun. 2023 Jun 5;33:101135. doi: 10.1016/j.conctc.2023.101135. eCollection 2023 Jun.
Personalized interventions that can be delivered remotely are needed to increase physical activity (PA) in older adults to reduce risk of CV disease and mortality. Prior research indicates that Behavioral Change Techniques (BCTs) (e.g., goal setting, self-monitoring, behavioral repetition) can instill a habit for increasing daily walking. However, past interventions relied on between-subject randomized clinical trials, which can only only be informative about response of the hypothetical average person. Personalized trial designs can identify the benefits of an intervention for a specific individual although extended periods are required for collecting frequent measurements within-subject. Advances in remote, virtual technologies (e.g., text messaging, activity trackers), integrated with automatic platforms, can meet these requirements because they capacitate delivery of BCT interventions, and collection of data during daily life without personal contact. This Stage I-b trial is designed test whether a virtual, personalized intervention is feasible and acceptable to older adults, can elicit participant adherence and exhibit preliminary evidence for efficacy.
A series of up to 60 single-arm, personalized trials, involving no personal contact, will recruit adults, 45-75 years of age, to wear an activity tracker during a 2-week baseline and a 10-week intervention. Five BCT prompts to execute a walking plan will be delivered on a daily basis during the intervention phase. Participants will rate satisfaction with personalized trial components and whether automaticity of the walking plan can be achieved. Step-counts, adherence to the walking plan and self-monitoring of step-count will also be recorded.
需要能够远程提供的个性化干预措施，以增加老年人的身体活动（PA），降低心血管疾病风险和死亡率。先前的研究表明，行为改变技术（BCTs）（例如目标设定、自我监测、行为重复）可以养成增加日常步行的习惯。然而，过去的干预措施依赖于组间随机临床试验，而这种试验只能说明假设的普通人的反应情况。个性化试验设计可以确定干预措施对特定个体的益处，尽管需要较长时间来收集个体内部的频繁测量数据。远程虚拟技术（例如短信、活动追踪器）与自动平台相结合的进展，可以满足这些要求，因为它们能够提供BCT干预措施，并在无需人际接触的日常生活中收集数据。这项I-b期试验旨在测试虚拟个性化干预措施对老年人是否可行且可接受，是否能引起参与者的依从性，并展示初步的疗效证据。
一系列多达60项的单臂个性化试验，不涉及人际接触，将招募45至75岁的成年人，在为期2周的基线期和10周的干预期佩戴活动追踪器。在干预期，每天会发送五条执行步行计划的BCT提示信息。参与者将对个性化试验组件的满意度以及步行计划的自动性是否能够实现进行评分。还将记录步数、对步行计划的依从性以及步数的自我监测情况。
