Donnelly Susie, Reginatto Brenda, Kearns Oisin, Mc Carthy Marie, Byrom Bill, Muehlhausen Willie, Caulfield Brian
Applied Research for Connected Health, University College Dublin, Dublin, Ireland.
ICON plc, Dublin, Ireland.
J Med Internet Res. 2018 Jun 19;20(6):e220. doi: 10.2196/jmir.9638.
Despite an aging population, older adults are typically underrecruited in clinical trials, often because of the perceived burden associated with participation, particularly travel associated with clinic visits. Conducting a clinical trial remotely presents an opportunity to leverage mobile and wearable technologies to bring the research to the patient. However, the burden associated with shifting clinical research to a remote site requires exploration. While a remote trial may reduce patient burden, the extent to which this shifts burden on the other stakeholders needs to be investigated.
The aim of this study was to explore the burden associated with a remote trial in a nursing home setting on both staff and residents.
Using results from a grounded analysis of qualitative data, this study explored and characterized the burden associated with a remote trial conducted in a nursing home in Dublin, Ireland. A total of 11 residents were recruited to participate in this trial (mean age: 80 years; age range: 67-93 years). To support research activities, we also recruited 10 nursing home staff members, including health care assistants, an activities co-ordinator, and senior nurses. This study captured the lived experience of this remote trial among staff and residents and explored the burden associated with participation. At the end of the trial, a total of 6 residents and 8 members of staff participated in semistructured interviews (n=14). They reviewed clinical data generated by mobile and wearable devices and reflected upon their trial-related experiences.
Staff reported extensive burden in fulfilling their roles and responsibilities to support activities of the trial. Among staff, we found eight key characteristics of burden: (1) comprehension, (2) time, (3) communication, (4) emotional load, (5) cognitive load, (6) research engagement, (7) logistical burden, and (8) product accountability. Residents reported comparatively less burden. Among residents, we found only four key characteristics of burden: (1) comprehension, (2) adherence, (3) emotional load, and (4) personal space.
A remote trial in a nursing home setting can minimize the burden on residents and enable inclusive participation. However, it arguably creates additional burden on staff, particularly where they have a role to play in locally supporting and maintaining technology as part of data collection. Future research should examine how to measure and minimize the burden associated with data collection in remote trials.
尽管人口老龄化，但老年人通常在临床试验中的招募人数不足，这往往是因为人们认为参与试验存在负担，尤其是与门诊就诊相关的出行负担。远程开展临床试验提供了一个利用移动和可穿戴技术将研究带到患者身边的机会。然而，将临床研究转移到远程站点所带来的负担需要进行探索。虽然远程试验可能会减轻患者负担，但这种方式对其他利益相关者造成负担转移的程度仍有待研究。
本研究的目的是探讨在养老院环境中进行远程试验对工作人员和居民所带来的负担。
利用对定性数据进行扎根分析的结果，本研究探索并描述了在爱尔兰都柏林一家养老院进行远程试验所带来的负担。总共招募了11名居民参与该试验（平均年龄：80岁；年龄范围：67 - 93岁）。为支持研究活动，我们还招募了10名养老院工作人员，包括医疗保健助理、活动协调员和高级护士。本研究记录了工作人员和居民在这次远程试验中的实际经历，并探讨了参与试验所带来的负担。试验结束时，共有6名居民和8名工作人员参与了半结构化访谈（共14人）。他们查看了移动和可穿戴设备生成的临床数据，并反思了与试验相关的经历。
工作人员报告称在履行支持试验活动的职责时负担过重。在工作人员中，我们发现了负担的八个关键特征：（1）理解，（2）时间，（3）沟通，（4）情绪负担，（5）认知负担，（6）研究参与度，（7）后勤负担，以及（8）产品问责。居民报告的负担相对较轻。在居民中，我们只发现了负担的四个关键特征：（1）理解，（2）依从性，（3）情绪负担，以及（4）个人空间。
在养老院环境中进行远程试验可以将居民的负担降至最低，并实现包容性参与。然而，可以说这给工作人员带来了额外负担，特别是在他们作为数据收集的一部分需要在当地支持和维护技术方面发挥作用时。未来的研究应该探讨如何衡量和最小化远程试验中与数据收集相关的负担。
