Improving outcomes in persons with long COVID-related fatigue using energy management education: A target trial emulation study

Background: There is limited evidence for managing persons with post-COVID-19 condition, also known as long COVID, due to the unappreciated nature of this disease. One of the most common symptoms is fatigue, experienced mainly as severe, impacting cognition with extended activities of daily living and social activities (Sivan, Parkin, et al., 2022), which causes significant distress and disability to the affected individual and prevents them from returning to previous life routines, work, and social life (Townsend et al., 2020). Recommendations based mainly on the opinions of experts and patients' lived experiences underline the need for a multidisciplinary approach that includes self-management education, peer support, and symptom management strategies (NICE guideline, 2022). Energy management education (EME) (Hersche, Weise, Michel, Kesselring, Barbero, et al., 2019) is a manualized, evidence-based occupational therapy (OT) peer-group self-management education for persons living with chronic disease-related fatigue, developed to be implemented in the Swiss health care context. After the first COVID-19 wave, several institutions in Switzerland started to use the EME protocol and its materials in their OT services for persons with long COVID. At the Clinic for Neurorehabilitation Basel (REHAB), EME is part of a multidisciplinary rehabilitation program for persons with long COVID. In 2022, we conducted a feasibility study at REHAB with a pre-post design to investigate the effect sizes and procedural and methodological issues of a future clinical trial. Aims: The purpose of this project is three-fold. The primary aim is to evaluate if adding EME to standard care improves outcomes in persons with long COVID-related fatigue. The secondary aim is to explore the energy management behavior strategies applied in daily routines after participating in EME and investigate the influencing factors of implementing behavior changes. The third aim is to perform a cost-effectiveness analysis of EME. Methods: This is a two-arm prospective interventional study with a target trial emulation approach. The estimated sample size to guarantee 90% power is 122 (61/61). Participants in the experimental group will follow in addition to standard care interventions (e.g., physiotherapy) EME at three research sites (USZ, REHAB, and INSEL). The control group is selected from a pool of persons living with long COVID-related fatigue by their propensity score and matched 1:1 with persons in the experimental group. The control group receives the standard of care, including any rehabilitation intervention, except OT-based EME in the peer groups. Four self-reported questionnaires document the outcomes of interest at baseline (BL; week 0), after lesson 7 (T1; week 7), post-intervention (T2; week 15), and at follow-up (T3, week 24). The primary outcome is self-efficacy in performing energy management strategies. The secondary outcomes are the impact of fatigue, competency in performing activities of daily living, and health-related quality of life. At T3, behavior change in the energy management survey will collect data on stable used behavior strategies and perceived influencing factors. A cost-effectiveness profile of the experimental intervention will be performed. Expected results and impact: This study will deliver urgently needed data on the effectiveness of an intervention recommended by guidelines for managing persons with long COVID. Furthermore, the results will contribute to evidence-based self-management education in persons with chronic fatigue syndrome and other chronic conditions. OTs will gain more detailed insight into the behavior changes after EME, which will support coaching and offer a more informed perspective to persons with long COVID. Data from the cost-effectiveness analysis will provide rehabilitation managers, assurances, and policymakers with data for informed decisions regarding group-based rehabilitation interventions.