20 3. Select theory-based intervention methods that match the objectives and determinants and translate these into potential intervention strategies; 4. Integrate methods and the strategies into an organized program; 5. Plan for adoption, implementation and sustainability of the program in reallife contexts; 6. Generate the effect and perform process evaluations. The above steps of the IM protocol are linked to different studies and thereby chapters of this thesis. For example, Chapters 2 and 3 of this thesis focus on step one of the protocol. Chapter 4 is about the development of the intervention, and describes the results of steps two to five of the IM protocol. Chapters 5 and 6 align with steps five and six of the IM protocol, which are about the effectiveness of the intervention. In addition to the IM protocol, we used co-creation methods to ensure our intervention would meet the specific needs of patients with LHL and their HCPs. Extensive participation of these target groups was extra important to adapt the intervention as good as possible to the context of CKD. Co-creation is defined as a participatory approach in cooperation between researchers and target groups, to ensure that interventions meet their needs, preferences and abilities with an understanding of the specific context and setting[62,65,74–77]. We incorporated co-creation approaches in several steps of the IM protocol. For example, to identify the most important health literacy and self-management related problems, we used interviews and group meetings. In addition, to test the usability and content of the interventions, we evaluated concepts of the intervention during pilot-tests with patients and HCPs. INVESTIGATING THE EFFECTIVENESS AND COST-EFFECTIVENESS OF OUR INTERVENTION After the development, a quasi-experimental study was performed to determine the effectiveness and cost-effectiveness of the intervention. A comparison of outcomes between the intervention and control group was related to the level of health literacy, self-management, and communication. These outcomes can either relate to the competences of patients or those of HCPs. Additionally, the impact of the intervention on the patients’ clinical outcomes, such as glomerular
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