Unit of Biostatistics, Epidemiology and Public Health, Department of Cardiac, Thoracic, Vascular Sciences and Public Health, University of Padova, 35121 Padova, Italy.
Department of Cardiac, Thoracic and Vascular Sciences, University of Padua Medical School, 35121 Padua, Italy.
Int J Environ Res Public Health. 2021 Jul 4;18(13):7171. doi: 10.3390/ijerph18137171.
Wearable devices (WDs) can objectively assess patient-reported outcomes (PROMs) in clinical trials. In this study, the feasibility and acceptability of using commercial WDs in elderly patients undergoing transcatheter aortic valve replacement (TAVR) or surgical aortic valve replacement (SAVR) will be explored. This is a prospective observational study. Participants were trained to use a WD and a smartphone to collect data on their physical activity, rest heart rate and number of hours of sleep. Validated questionnaires were also used to evaluate these outcomes. A technology acceptance questionnaire was used at the end of the follow up. In our participants an overall good compliance in wearing the device (75.1% vs. 79.8%, SAVR vs. TAVR) was assessed. Half of the patients were willing to continue using the device. Perceived ease of use is one of the domains that scored higher in the technology acceptance questionnaire. In this study we observed that the use of a WD is accepted in our frail population for an extended period. Even though commercial WDs are not tailored for clinical research, they can produce useful information on patient behavior, especially when coordinated with intervention tailored to the single patient.
可穿戴设备（WDs）可客观评估临床试验中的患者报告结局（PROMs）。本研究旨在探讨在接受经导管主动脉瓣置换术（TAVR）或外科主动脉瓣置换术（SAVR）的老年患者中使用商业 WDs 的可行性和可接受性。这是一项前瞻性观察研究。参与者接受培训，使用 WD 和智能手机来收集其身体活动、静息心率和睡眠时间的数据。还使用了经过验证的问卷来评估这些结果。在随访结束时使用了技术接受问卷。在我们的参与者中，评估了佩戴设备的总体良好依从性（75.1% vs. 79.8%，SAVR 与 TAVR）。一半的患者愿意继续使用该设备。感知易用性是技术接受问卷中得分较高的领域之一。在这项研究中，我们观察到 WDs 在我们的虚弱人群中可以接受长期使用。尽管商业 WDs 并非专为临床研究设计，但它们可以提供有关患者行为的有用信息，尤其是当与针对单个患者的干预措施协调使用时。
