Background: Post-COVID-19 syndrome (PCS; also known as "long COVID") is a relatively novel disease comprising physical, psychological, and cognitive complaints persisting several weeks to months after acute infection with SARS-CoV-2. Approximately 10% of patients with COVID-19 are affected by long-term symptoms. However, effective treatment strategies are lacking. The ErgoLoCo (Occupational Therapy [Ergotherapie] for Long COVID) study was designed to develop and evaluate a novel occupational therapy (OT) concept of online delivery of therapy for long COVID.
Objective: The primary study objective is to assess the feasibility of the online OT intervention in PCS. Secondary aims include the evaluation of online OT concerning cognitive problems, occupational performance, and social participation.
Methods: This randomized controlled interventional pilot study involves parallel mixed methods process analyses and a realist evaluation approach. A total of 80 clients with PCS aged at least 16 years will be recruited into two interventional groups. The control cohort (watch and wait) comprises 80 clients with long COVID. Treatment is provided through teletherapy (n=40) or delivery of prerecorded videos (n=40) using the same standardized OT concept twice weekly over 12 weeks. Analyses of quantitative questionnaires and qualitative interviews based on the theoretical framework of acceptability will be performed to assess feasibility. Focus group meetings will be used to assess how acceptable and helpful the intervention was to the participating occupational therapists. Standardized tests will be used to assess the initial efficacy of the intervention on neurocognitive performance; limitations in mobility, self-care, and everyday activities; pain; disabilities; quality of life (QoL); social participation; and anxiety and depression in PCS, and the possible effects of online OT on these complaints.
Results: The German Ministry of Education and Research provided funding for this research in March 2022. Data collection took place from October 2022 to August 31, 2023. Data analysis will be completed by the end of April 2024. We anticipate publishing the results in the fall of 2024.
Conclusions: Despite the enormous clinical need, effective and scalable treatment options for OT clients who have PCS remain scarce. The ErgoLoCo study will assess whether online-delivered OT is a feasible treatment approach in PCS. Furthermore, this study will assess the effect of the intervention on cognitive symptoms, QoL, and occupational performance and participation in everyday life. Particular emphasis will be placed on the experiences of clients and occupational therapists with digitally delivered OT. This study will pave the way for novel and effective treatment strategies in PCS.
Trial registration: German Clinical Trial Registry DRKS00029990; https://drks.de/search/de/trial/DRKS00029990.
International registered report identifier (irrid): PRR1-10.2196/50230.
Keywords: COVID-19; RCT; SARS-CoV-2; acceptability; cognitive deficits; controlled trials; digital health; digital intervention; effectiveness; feasibility; internet based; long Covid; occupational therapy; online therapy; online treatment; pandemic; post COVID-19 condition; prerecorded; randomized controlled trial; video.
©Christina Müllenmeister, Andrea Stoelting, Dominik Schröder, Tim Schmachtenberg, Simon Ritter, Iman El-Sayed, Sandra Steffens, Frank Klawonn, Sandra Klawitter, Stefanie Homann, Marie Mikuteit, Christoph Berg, Georg Behrens, Eva Hummers, Aisha Cook, Frank Müller, Alexandra Dopfer-Jablonka, Christine Happle. Originally published in JMIR Research Protocols (https://www.researchprotocols.org), 13.05.2024.