Key considerations for digital decentralised clinical trials from a feasibility study assessing pacing interventions for long COVID
Post COVID-19 condition or long COVID is highly prevalent and often debilitating, with key symptoms including fatigue, breathlessness, and brain fog. There is currently a lack of evidence-based treatments for this highly complex syndrome. There is a need for clinical trial platforms to rapidly evaluate nonpharmacological treatments to support affected individuals with symptom management. We co-produced a mixed methods feasibility study to evaluate a multi-arm digital decentralised clinical trial (DCT) platform to assess non-pharmacological interventions for Long COVID, using pacing interventions as an exemplar. The study demonstrated that the platform was able to successfully e-consent participants, randomise them into one of four intervention arms, capture baseline data, and capture outcomes relevant to a health economic evaluation. The study also highlighted several challenges, including difficulties with recruitment, imposter participants, and high attrition rates. We highlight how these challenges can potentially be mitigated to make a fully powered DCT more feasible.
Authors
- Shamil Haroon (ORCID: https://orcid.org/0000-0002-0096-1413)
- Christel McMullan (ORCID: https://orcid.org/0000-0002-0878-1513)
- Elin Haf Davies (ORCID: https://orcid.org/0000-0002-4987-0088)
- Sarah Hughes (ORCID: https://orcid.org/0000-0001-5656-1198)
- Krishnarajah Nirantharakumar (ORCID: https://orcid.org/0000-0002-6816-1279)
- Sarah Elizabeth Flanagan (ORCID: https://orcid.org/0000-0002-8670-6340)
- Felicity Jeyes
- Amy Chong
- Yvonne Alder
- Louise Jackson (ORCID: https://orcid.org/0000-0001-8492-0020)
- Naijie Guan (ORCID: https://orcid.org/0000-0003-3978-5776)
- Grace Turner (ORCID: https://orcid.org/0000-0002-9783-9413)
- Lewis Buckland
- Melanie Calvert (ORCID: https://orcid.org/0000-0002-1856-837X)
- Chris Frost (ORCID: https://orcid.org/0000-0003-0098-9915)
- Olalekan Lee Aiyegbusi (ORCID: https://orcid.org/0000-0001-9122-8251)
- Anuradhaa Subramanian (ORCID: https://orcid.org/0000-0001-8875-7363)
- David Stanton
Institutions
- National Institute for Health and Care Research (GB)
- Cellular Therapeutics (United Kingdom) (GB)
- NIHR Research Delivery Network (GB)
- NIHR Birmingham Biomedical Research Centre (GB)
- University of Birmingham (GB)
Publication Details
- Journal
- Scientific Reports
- Published
- 2024-09-27
- DOI
- https://doi.org/10.1038/s41598-024-61827-4
- Citations
- 4
- Primary Topic
- Long-Term Effects of COVID-19
- Type
- article
- Field-Weighted Citation Impact
- 1.48
Funders
- National Institute for Health and Care Research