Evaluating the Feasibility, Acceptance, and Beneficial Effects of Online Occupational Therapy for Post–COVID-19 Condition: Protocol for a Randomized Controlled Trial (ErgoLoCo Study) (Preprint)

Abstract

BACKGROUND Post COVID-19 condition (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. Around 10% of persons experiencing COVID-19 are affected by long-term symptoms. Thus far, effective treatment strategies against Long COVID are scarce. OBJECTIVE ErgoLoCo strives to develop and evaluate a novel, online-delivered occupational therapy for long COVID. The primary objective of this study is to assess the feasibility of online occupational therapy in long COVID. The secondary aims are the evaluation of online occupational therapy's effects on cognitive problems and occupational performance and data collection on the individual experiences of clients and medical professionals with digital occupational therapy. METHODS This randomized controlled interventional pilot study has parallel mixed-methods process analyses and a realist evaluation approach. We plan to enrol 80 long COVID clients aged 16 years or older in an interventional group. The control cohort consists of n=80 long COVID clients without digital occupational therapy. Treatment is provided through an online occupational therapy protocol (occupational therapy twice weekly over 12 weeks, delivered either via live online meetings (n=40) or in prerecorded video sessions (n=40). To analyze the central question of this pilot study (Is online occupational therapy feasible in long COVID?), quantitative questionnaires and qualitative interviews based on the Theoretical Framework of Acceptability (TFA) will be used. Furthermore, focus group meetings assess how helpful and acceptable the intervention was to occupational therapists. To assess neurocognitive impairments and limitations in mobility, self-care, usual activities, pain, disabilities, anxiety, as well as depression in Post COVID-19 condition (Long COVID) and the possible effects of online occupational therapy on these problems, standardized tests such as WIT-2, D2r, NeuroQual, COPM, and EQ-5D-5L will be used. The study is registered in the German Clinical Trial Registry (# DRKS00029990) and reviewed by the institutional review boards of participating sites. RESULTS We will assess whether digital occupational therapy is a feasible treatment for long COVID. We will furthermore test possible improvements in cognitive symptoms and performance in relevant daily activities after completion of the online occupational therapy program and analyze differences in occupational therapy acceptance when comparing personal care to prerecorded video therapy. CONCLUSIONS This randomized controlled pilot study is designed to evaluate the feasibility, acceptability and effectiveness of occupational therapy in long COVID and gain first insights into possible beneficial effects of digital occupational therapy in this disease. CLINICALTRIAL German Clinical Trial Registry (# DRKS00029990)