161 with the registered trial, we included patients of various health literacy levels, but oversampled patients with LHL. This enabled to analyse the intervention effectiveness among health literacy subgroups, and to guarantee sufficient participation, during COVID-19. SAMPLE SIZE To achieve 80% power, an a priori calculation for multilevel analysis set our needed sample on 91 patients nested under 38 professionals in each group. First, the number of professionals was based upon the outcome ‘use of health literacy communication strategies’ and assumed an effect size of 0.65. Second, we estimated the number of patients needed to detect a change of 10.0 in the intervention-control group difference for the patient activation measure[8] with a standard deviation of 15.8[17], and a two-tailed alpha of 0.05. To allow for 5% attrition among professionals and 10% attrition among patients, we aimed to enrol 40 professionals and 102 patients per group. INTERVENTION GoYK is a multi-component intervention, offered on top of care-as-usual, developed in co-creation with patients and professionals[15]. For patients, the intervention enhances CKD knowledge, communication and self-management through simple text and visuals. Professionals received an e-learning and a workshop, based upon the effective health literacy training of Kaper et al.[18]. Supplementary file 1 contains a detailed description. CARE-AS-USUAL In line with guidelines [19], patients had two to four annual consultations with a general practitioner, nephrologist or a specialized nurse practitioner. If needed, patients in the nephrology clinics received additional care from a nurse practitioner, dietician or social worker. Patients in CKD-stage 4 received more intensive care, often having consultations every four to six weeks. Protocolled consultation topics in all settings were lab results, medication, lifestyle and, if applicable, co-morbid diseases.
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