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This study investigated participant satisfaction in three trial arms: a fully decentralised arm, a hybrid arm and a conventional arm in individuals with type 2 diabetes mellitus.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods<\/jats:title>\n                    <jats:p>RADIAL, a three-arm, low-intervention, phase IV proof-of-concept trial, was set up in six European countries and aimed to evaluate the scientific and operational quality as well as the feasibility of trial approaches with different levels of decentralisation. Participant satisfaction was measured at three time points: at start (week 0), during (week 12), and at the end of the trial (week 24), using digital questionnaires.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Results<\/jats:title>\n                    <jats:p>In all arms, 72% to 100% of participants were satisfied with overall trial participation, but satisfaction decreased over time in the hybrid arm compared to the conventional arm. Participants reported issues with trial technologies as reasons for their dissatisfaction in the hybrid arm, which was further substantiated by dissatisfaction with specific digital trial components. Satisfaction with the time commitments and data collection was also lower in the hybrid arm than in the conventional arm. Nevertheless, participants in both arms were very satisfied with the comprehensibility of the information before trial start, feeling of safety, interaction with trial staff, and timing of trial appointments, ranging from 92% to 100%. Due to the small number of seven participants in the remote arm, no meaningful conclusions on satisfaction could be drawn in this arm.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Conclusions<\/jats:title>\n                    <jats:p>Decentralisation seems to be acceptable to trial participants, as trial activities can be responsibly shifted from the research site to participants\u2019 homes, e.g. decentralised, without materially impacting participant satisfaction. However, technological issues negatively affected satisfaction in the hybrid arm, highlighting the need to utilise fit-for-purpose technologies and adequately address potential digital challenges in trials. Including participant satisfaction measures in trials deepens the understanding of how participants experience different (decentralised) trial activities, which can help to tailor future trials to their needs.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration<\/jats:title>\n                    <jats:p>ClinicalTrials.gov NCT05780151 (2023-03-08)\u00a0and CTIS 2022-500,449-26-00\u00a0(2022-03-28)<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1186\/s13063-026-09616-4","type":"journal-article","created":{"date-parts":[[2026,3,12]],"date-time":"2026-03-12T03:06:24Z","timestamp":1773284784000},"update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":0,"title":["Participant satisfaction across three trial arms with varying degrees of decentralisation in the RADIAL proof-of-concept trial"],"prefix":"10.1186","volume":"27","author":[{"given":"Julia","family":"Kopanz","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-1463-8243","authenticated-orcid":false,"given":"Mira G. 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Recommendation paper on decentralised elements in clinical trials. 2022. https:\/\/health.ec.europa.eu\/system\/files\/2022-12\/mp_decentralised-elements_clinical-trials_rec_en.pdf. Accessed 23 Oct 2025."},{"issue":"5","key":"9616_CR53","doi-asserted-by":"publisher","first-page":"1057","DOI":"10.1002\/cpt.70075","volume":"118","author":"K Lipinska","year":"2025","unstructured":"Lipinska K, van Weelij D, Lagerwaard B, Rutgrink L, Vardianu E, Naster P, et al. Selecting and preparing clinical sites for the successful conduct of decentralized clinical trial activities-findings from the Trials@Home RADIAL proof-of-concept trial. Clin Pharmacol Ther. 2025;118(5):1057\u201366.","journal-title":"Clin Pharmacol Ther"}],"container-title":["Trials"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/article\/10.1186\/s13063-026-09616-4","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s13063-026-09616-4.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1186\/s13063-026-09616-4.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2026,4,20]],"date-time":"2026-04-20T09:03:56Z","timestamp":1776675836000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1186\/s13063-026-09616-4"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2026,3,12]]},"references-count":53,"journal-issue":{"issue":"1","published-online":{"date-parts":[[2026,12]]}},"alternative-id":["9616"],"URL":"https:\/\/doi.org\/10.1186\/s13063-026-09616-4","relation":{},"ISSN":["1745-6215"],"issn-type":[{"value":"1745-6215","type":"electronic"}],"subject":[],"published":{"date-parts":[[2026,3,12]]},"assertion":[{"value":"24 October 2025","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"1 March 2026","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"12 March 2026","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"The RADIAL trial was performed in accordance with the principles of the Declaration of Helsinki, good scientific practice, and the EU General Data Protection Regulation. The trial was submitted in two parts through the Clinical Trials Information System (CTIS) and got authorised (2022\u2013500,449-26-00). In the UK, the trial issued a favourable ethical opinion by both the Health Research Authority and the East of England\u2014Essex Research Ethics Committee (IRAS ID 1006010, REC reference: 22\/EE\/0184). The trial was registered in the ClinicalTrials.gov database under identifier NCT05780151. All participants signed the informed consent form before trial participation.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"Not applicable.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"LR is an employee of Sanofi and holds shares in this company. The other authors have no conflicts of interest to declare.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}}],"article-number":"311"}}