Marco Boonstra

123 METHODS In this study, we followed the IM protocol, which describes an iterative process to develop interventions by 1) analyzing the needs and problems of the target group, 2) formulating change objectives, determinants and expected outcomes, 3) generating and developing theory- and evidence-based intervention strategies, 4) translating these into a produced intervention program, and 5) evaluating adoption (i.e. usability, comprehensibility, fit to the needs), and potential implementation barriers of the intervention[32]. Within the steps of the IM protocol, we applied mixed-methods to systematically co-create the intervention. The Medical Ethical Committee of the University Medical Center Groningen (UMCG) approved the study (number: 201900259).. PARTICIPANT ELIGIBILITY AND RECRUITMENT We included Dutch CKD patients with LHL (n=19) and HCPs (n=15) from general practices and nephrology clinics, and educators (n=3) and students in nursing and medicine (n=4) from two universities and two nephrology clinics. These participated in at least one step of our study. Our recruitment started with the HCPs, educators and students. They received an e-mail about our research, which asked consent for participation. In each GP and nephrology clinic, one HCP became a contact person. This HCP supported inclusion of additional HCPs via snowball sampling, and approached patients to include in steps 2 and 3 of the IM protocol. Patients were eligible if they 1) were adult, 2) experienced >3 months of CKD, stages 2-5, and 3) had LHL, measured with the All Aspects of Health Literacy Scale[33]. Major cognitive problems and terminal illness were reasons for exclusion. The HCPs received the eligibility criteria and a checklist, explaining signs of LHL, based on scientific evidence[34,35]. First, the HCPs approached 46 eligible patients by phone or during consultations and provided them with an information letter. Second, the first author provided patients with further information; 19 patients were eligible and included. In steps 2 and 3, it became clear that the problems, needs and context of dialysis patients greatly differed from patients in ambulatory settings (CKD-stages 2-4). The intervention produced in step 4 was targeted towards ambulatory setting. Therefore, we excluded the eleven dialysis patients from that moment. Of the remaining eight eligible patients, four patients dropped out, because of SARS-

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