Energy management education for persons living with long COVID-related fatigue (EMERGE): protocol of a two-parallel arms target trial emulation study in a multicentre outpatient intervention setting with an online control group register.

Abstract

Energy management education (EME) is a manualised, evidence-based self-management education programme developed and delivered by occupational therapists for persons living with chronic disease-related fatigue. Studies have shown that EME can positively affect self-efficacy, fatigue impact and quality of life in persons with chronic conditions, while data on persons with long COVID are lacking.The primary aim is to evaluate if adding EME to the standard care improves outcomes in persons with long COVID-related fatigue. The secondary aim is to explore the energy management behavioural strategies applied in daily routines and investigate the influencing factors of implementing behavioural changes. The third aim is to perform a cost-effectiveness analysis of EME. Using observational data, we will emulate a prospective two-parallel arms target trial to assess whether adding EME to the standard care is associated with improved outcomes in patients with long COVID-related fatigue. The estimated sample size to detect a post-intervention difference of 1.5 points in self-efficacy to implement energy conservation strategies with 90% power (0.05 alpha) is 122 people (1:1 ratio).Persons with long COVID-related fatigue who follow EME as part of their standard care will be recruited and included in the experimental group (EG), while potential participants for the control group (CG) will be recruited from a register and prospectively matched to a participant in the EG by applying the propensity score technique. The 'standard of care' of the CG will include any intervention, except occupational therapy-based EME in peer groups. The causal contrast of interest will be the per-protocol effect. Four self-reported questionnaires (fatigue impact, self-efficacy in performing energy management strategies, competency in performing daily activities, health-related quality of life) will be administered at baseline (T0; week 0), after lesson 7 (T1; week 6), post-intervention (T2; week 14) and follow-up (T3, week 24). Our main assessment will be at T2. Disease-related and productivity cost data will be collected, and a cost-effectiveness profile of the EME intervention will be compared with standard care. Ethical approval has been obtained from the competent Swiss ethics commission.Findings will be reported (1) to the study participants; (2) to patient organisations and hospitals supporting EMERGE; (3) to funding bodies; (4) to the national and international occupational therapy community and healthcare policy; (5) will be presented at local, national, and international conferences and (6) will be disseminated by peer-review publications.