Adapting, restarting, and terminating a randomised control trial for people with cystic fibrosis: Reflections on the impact of the COVID-19 pandemic UPON research in a clinical population
dc.contributor.author | Tomlinson, OW | |
dc.contributor.author | Barker, AR | |
dc.contributor.author | Denford, S | |
dc.contributor.author | Williams, CA | |
dc.date.accessioned | 2024-04-10T14:32:00Z | |
dc.date.issued | 2024-03-27 | |
dc.date.updated | 2024-04-09T15:53:10Z | |
dc.description.abstract | Background: Habitual physical activity (PA) and exercise form a cornerstone of the management of cystic fibrosis (CF), a genetically inherited pulmonary and digestive condition – whereby telehealth platforms have been proposed as a mechanism to engage remotely people with CF in PA and exercise. Methods: To test this, in early 2020, the ‘ActivOnline: Physical Activity in Cystic Fibrosis Trial’ (ActiOn PACT) randomised control trial was established to examine whether an online intervention was effective at increasing PA in adolescents and adults with CF. Results: The emergence of the COVID-19 pandemic in 2020 forced this trial to be paused and modified, with the adoption of online recruitment and remote assessment of outcome measures. Despite such adaptations in accord with frameworks developed by the National Institute for Health Research, this trial failed to recruit and was subsequently terminated. Conclusions: This article details the authors reflections upon the proposed reasons for lack of recruitment, including improved technology and medications for people with CF, and contextualises this finding in relation to the wider issue of non-reporting of trial results in clinical research. | en_GB |
dc.description.sponsorship | Cystic Fibrosis Trust | en_GB |
dc.description.sponsorship | Sport England | en_GB |
dc.identifier.citation | Vol. 39, article 101294 | en_GB |
dc.identifier.doi | https://doi.org/10.1016/j.conctc.2024.101294 | |
dc.identifier.uri | http://hdl.handle.net/10871/135719 | |
dc.identifier | ORCID: 0000-0003-4063-7682 (Tomlinson, Owen W) | |
dc.identifier | ORCID: 0000-0002-1740-6248 (Williams, Craig A) | |
dc.language.iso | en | en_GB |
dc.publisher | Elsevier | en_GB |
dc.rights | © 2024 The Authors. Published by Elsevier Inc. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/). | en_GB |
dc.subject | Randomised control trial | en_GB |
dc.subject | COVID-19, trial modification | en_GB |
dc.subject | Respiratory disease | en_GB |
dc.title | Adapting, restarting, and terminating a randomised control trial for people with cystic fibrosis: Reflections on the impact of the COVID-19 pandemic UPON research in a clinical population | en_GB |
dc.type | Article | en_GB |
dc.date.available | 2024-04-10T14:32:00Z | |
dc.identifier.issn | 2451-8654 | |
exeter.article-number | 101294 | |
dc.description | This is the final version. Available on open access from Elsevier via the DOI in this record. | en_GB |
dc.description | Availability of data: There is no study data to report, and therefore no data is available. | en_GB |
dc.identifier.journal | Contemporary Clinical Trials Communications | en_GB |
dc.rights.uri | https://creativecommons.org/licenses/by/4.0/ | en_GB |
dcterms.dateAccepted | 2024-03-27 | |
rioxxterms.version | VoR | en_GB |
rioxxterms.licenseref.startdate | 2024-03-27 | |
rioxxterms.type | Journal Article/Review | en_GB |
refterms.dateFCD | 2024-04-10T14:28:11Z | |
refterms.versionFCD | VoR | |
refterms.dateFOA | 2024-04-10T14:32:09Z | |
refterms.panel | A | en_GB |
refterms.dateFirstOnline | 2024-03-27 |
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Except where otherwise noted, this item's licence is described as © 2024 The Authors. Published by Elsevier Inc. This is an open access article under the CC BY license (http://creativecommons.org/licenses/by/4.0/).