Participant and research team perspectives on the conduct of a remote therapeutic COVID-19 clinical trial: A mixed methods approach
Abstract Background: Responding to the need to investigate potential treatments of COVID-19, a research team employed a telehealth platform to determine whether niclosamide, an oral anthelmintic drug that had shown antiviral activity, reduced SARS-CoV-2 shedding and duration of symptoms in patient...
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| Format: | Article |
| Language: | English |
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Cambridge University Press
2022-01-01
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| Series: | Journal of Clinical and Translational Science |
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| Online Access: | https://www.cambridge.org/core/product/identifier/S2059866122003971/type/journal_article |
| _version_ | 1811156527617146880 |
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| author | Denise H. Daudelin Sarah K. Brewer Alyssa B. Cabrera Dorothy Dulko Harry P. Selker |
| author_facet | Denise H. Daudelin Sarah K. Brewer Alyssa B. Cabrera Dorothy Dulko Harry P. Selker |
| author_sort | Denise H. Daudelin |
| collection | DOAJ |
| description |
Abstract
Background:
Responding to the need to investigate potential treatments of COVID-19, a research team employed a telehealth platform to determine whether niclosamide, an oral anthelmintic drug that had shown antiviral activity, reduced SARS-CoV-2 shedding and duration of symptoms in patients with mild-to-moderate symptoms of COVID-19. To encourage compliance with patient self-quarantine, this randomized placebo-controlled clinical trial was conducted utilizing a remote telehealth design to complete all study visits, monitor symptoms, and coordinate participant self-collected specimens.
Methods:
A mixed methods approach employing surveys and interviews of trial participants and interviews of research team members was used to collect their experiences with and perspectives on the acceptability of the remote clinical trial design and delivery.
Results:
Of the 67 eligible trial participants invited to take part in a study to evaluate the telehealth platform, 46% (n = 31) completed a post-participation survey. While 97% (n = 30) of respondents had not previously participated in a clinical trial, 77% (n = 24) reported they would consider taking part in a future remote research study. The majority of respondents were moderately or very comfortable (93%) with using the technology.
Conclusions:
The COVID-19 crisis was a call to action to expand understanding of the conduct of remote clinical trials, including the experiences of research participants. Our findings showed that this approach can be both effective for the conduct of research and positive for participants. Further research on the use of telehealth research platforms seems warranted in rural, underserved populations, and remote trials of prevention, screening, and treatment.
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| first_indexed | 2024-04-10T04:53:11Z |
| format | Article |
| id | doaj.art-f347010b76a04d99a806fb4e37f0b9fd |
| institution | Directory Open Access Journal |
| issn | 2059-8661 |
| language | English |
| last_indexed | 2024-04-10T04:53:11Z |
| publishDate | 2022-01-01 |
| publisher | Cambridge University Press |
| record_format | Article |
| series | Journal of Clinical and Translational Science |
| spelling | doaj.art-f347010b76a04d99a806fb4e37f0b9fd2023-03-09T12:31:04ZengCambridge University PressJournal of Clinical and Translational Science2059-86612022-01-01610.1017/cts.2022.397Participant and research team perspectives on the conduct of a remote therapeutic COVID-19 clinical trial: A mixed methods approachDenise H. Daudelin0https://orcid.org/0000-0002-6758-7753Sarah K. Brewer1https://orcid.org/0000-0001-7703-0871Alyssa B. Cabrera2Dorothy Dulko3Harry P. Selker4Tufts Clinical and Translational Science Institute, Tufts University, Boston, MA, USA Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, MA, USATufts Clinical and Translational Science Institute, Tufts University, Boston, MA, USATufts Clinical and Translational Science Institute, Tufts University, Boston, MA, USATufts Clinical and Translational Science Institute, Tufts University, Boston, MA, USA Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, MA, USATufts Clinical and Translational Science Institute, Tufts University, Boston, MA, USA Institute for Clinical Research and Health Policy Studies, Tufts Medical Center, Boston, MA, USA Abstract Background: Responding to the need to investigate potential treatments of COVID-19, a research team employed a telehealth platform to determine whether niclosamide, an oral anthelmintic drug that had shown antiviral activity, reduced SARS-CoV-2 shedding and duration of symptoms in patients with mild-to-moderate symptoms of COVID-19. To encourage compliance with patient self-quarantine, this randomized placebo-controlled clinical trial was conducted utilizing a remote telehealth design to complete all study visits, monitor symptoms, and coordinate participant self-collected specimens. Methods: A mixed methods approach employing surveys and interviews of trial participants and interviews of research team members was used to collect their experiences with and perspectives on the acceptability of the remote clinical trial design and delivery. Results: Of the 67 eligible trial participants invited to take part in a study to evaluate the telehealth platform, 46% (n = 31) completed a post-participation survey. While 97% (n = 30) of respondents had not previously participated in a clinical trial, 77% (n = 24) reported they would consider taking part in a future remote research study. The majority of respondents were moderately or very comfortable (93%) with using the technology. Conclusions: The COVID-19 crisis was a call to action to expand understanding of the conduct of remote clinical trials, including the experiences of research participants. Our findings showed that this approach can be both effective for the conduct of research and positive for participants. Further research on the use of telehealth research platforms seems warranted in rural, underserved populations, and remote trials of prevention, screening, and treatment. https://www.cambridge.org/core/product/identifier/S2059866122003971/type/journal_articleRemote clinical trialCOVID-19research participant experience |
| spellingShingle | Denise H. Daudelin Sarah K. Brewer Alyssa B. Cabrera Dorothy Dulko Harry P. Selker Participant and research team perspectives on the conduct of a remote therapeutic COVID-19 clinical trial: A mixed methods approach Journal of Clinical and Translational Science Remote clinical trial COVID-19 research participant experience |
| title | Participant and research team perspectives on the conduct of a remote therapeutic COVID-19 clinical trial: A mixed methods approach |
| title_full | Participant and research team perspectives on the conduct of a remote therapeutic COVID-19 clinical trial: A mixed methods approach |
| title_fullStr | Participant and research team perspectives on the conduct of a remote therapeutic COVID-19 clinical trial: A mixed methods approach |
| title_full_unstemmed | Participant and research team perspectives on the conduct of a remote therapeutic COVID-19 clinical trial: A mixed methods approach |
| title_short | Participant and research team perspectives on the conduct of a remote therapeutic COVID-19 clinical trial: A mixed methods approach |
| title_sort | participant and research team perspectives on the conduct of a remote therapeutic covid 19 clinical trial a mixed methods approach |
| topic | Remote clinical trial COVID-19 research participant experience |
| url | https://www.cambridge.org/core/product/identifier/S2059866122003971/type/journal_article |
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