What motivates people with type 2 diabetes mellitus to participate in clinical trials from home?

IF 3.1 3区 医学 Q2 MEDICINE, RESEARCH & EXPERIMENTAL
Julia Kopanz, Bart Lagerwaard, Magdalena Beran, Jorien Veldwijk, Julia K. Mader, Tina Pöttler, Dietrich Tews, Diederick E. Grobbee, Mira G. P. Zuidgeest, the Trials@Home consortium
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Abstract

Decentralized clinical trials (DCTs), in which all or part of the trial activities are moved to the participants' immediate surroundings, promise to improve trial conduct. However, no evidence is available on what motivates people to participate in DCTs. Our aim was to determine the drivers and perceptions for participation in clinical trials with different decentralization levels in persons with type 2 diabetes mellitus. Five focus groups were conducted utilizing the nominal group technique in the Netherlands (n = 1), Germany (n = 1), and Austria (n = 3) with four to six participants per group. The focus groups were analyzed using thematic analysis. Of the 26 participants (10 females, median age: 66 years [IQR: 62–72]) 42% had previously participated in a trial, and almost all had internet access at home (96%). A total of seven main themes regarding participation in clinical trials (location, time investment, contact with healthcare professionals (HCPs), digital technologies, data collection, perceived risk, and motivation) were identified, of which a total of 20 drivers emerged. Perceptions regarding trial participation differed widely among participants, and individual preferences influenced which drivers were considered more important by participants. Flexibility of location and time spent on the trial were identified as the most motivating factors for participation in DCTs. Some drivers, such as digital infrastructure, digital literacy, home visits, personal interaction, and relationship with HCPs were perceived as both enablers and barriers, depending on personal preferences. However, most of the potential barriers regarding DCTs may be resolved by addressing them in the design of future DCTs.

Abstract Image

是什么促使 2 型糖尿病患者在家参与临床试验?
分散临床试验(DCTs)是指将全部或部分试验活动转移到参与者身边进行,有望改善试验的进行。然而,目前还没有证据表明人们参与分散临床试验的动机是什么。我们的目的是确定 2 型糖尿病患者参与不同分散程度临床试验的动力和看法。我们在荷兰(n = 1)、德国(n = 1)和奥地利(n = 3)采用名义小组技术开展了五个焦点小组,每个小组有四到六名参与者。焦点小组采用主题分析法进行分析。在 26 位参与者(10 位女性,年龄中位数:66 岁 [IQR:62-72])中,42% 曾参与过试验,几乎所有参与者(96%)都能在家上网。共确定了七个有关参与临床试验的主题(地点、时间投入、与医护人员(HCPs)的接触、数字技术、数据收集、感知风险和动机),其中共产生了 20 个驱动因素。参与者对参与试验的看法大相径庭,个人偏好影响了参与者认为哪些驱动因素更重要。地点的灵活性和用于试验的时间被认为是参与 DCT 的最大驱动因素。一些驱动因素,如数字基础设施、数字扫盲、家访、个人互动以及与保健医生的关系,根据个人偏好,既被视为促进因素,也被视为障碍。不过,在设计未来的 DCT 时,可以通过解决这些问题来消除 DCT 的大部分潜在障碍。
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来源期刊
Cts-Clinical and Translational Science
Cts-Clinical and Translational Science 医学-医学:研究与实验
CiteScore
6.70
自引率
2.60%
发文量
234
审稿时长
6-12 weeks
期刊介绍: Clinical and Translational Science (CTS), an official journal of the American Society for Clinical Pharmacology and Therapeutics, highlights original translational medicine research that helps bridge laboratory discoveries with the diagnosis and treatment of human disease. Translational medicine is a multi-faceted discipline with a focus on translational therapeutics. In a broad sense, translational medicine bridges across the discovery, development, regulation, and utilization spectrum. Research may appear as Full Articles, Brief Reports, Commentaries, Phase Forwards (clinical trials), Reviews, or Tutorials. CTS also includes invited didactic content that covers the connections between clinical pharmacology and translational medicine. Best-in-class methodologies and best practices are also welcomed as Tutorials. These additional features provide context for research articles and facilitate understanding for a wide array of individuals interested in clinical and translational science. CTS welcomes high quality, scientifically sound, original manuscripts focused on clinical pharmacology and translational science, including animal, in vitro, in silico, and clinical studies supporting the breadth of drug discovery, development, regulation and clinical use of both traditional drugs and innovative modalities.
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