1. Key considerations for digital decentralised clinical trials from a feasibility study assessing pacing interventions for long COVID
- Author
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Christel McMullan, Shamil Haroon, Grace Turner, Olalekan Lee Aiyegbusi, Anuradhaa Subramanian, Sarah E. Hughes, Sarah Flanagan, Krishnarajah Nirantharakumar, Elin Haf Davies, Chris Frost, Louise Jackson, Naijie Guan, Yvonne Alder, Amy Chong, Lewis Buckland, Felicity Jeyes, David Stanton, and Melanie Calvert
- Subjects
Decentralised trials ,Feasibility study ,Pacing intervention ,PROMs ,Long COVID ,Medicine ,Science - Abstract
Abstract 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.
- Published
- 2024
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