Tailored Complex Symptom Management Intervention for Adults with Advanced Kidney Disease and Their Informal Caregivers: Protocol for the COMFORT Research Program

Introduction: To co-design and test the effectiveness of a tailored COmplex symptom Management intervention FOR adulTs with advanced kidney disease and their informal caregivers along with healthcare professionals who deliver care and support to both patients and informal caregivers. Methods: Informed by Symptom Management Theory, COMFORT is a program of research involving multiple studies and structured around the United Kingdom Medical Research Council's framework for developing complex interventions. The program involves building capacity of nurse researchers across three studies: first development of an intervention using mixed methods, followed by co-design workshops and prototype testing; thereafter testing of the symptom intervention through a feasibility trial. Lastly, evaluation of the intervention's effectiveness and implementation using a type two hybrid randomised control trial design, focussing on both clinical outcomes and implementation fidelity. Conclusion: This research program is expected to demonstrate that the COMFORT intervention is superior to standard care in improving symptom burden among adults with advanced kidney disease and reduce caregiver burden among informal caregivers. The COMFORT Nursing Program addresses a critical gap in clinical practice by focusing on non-pharmacological interventions tailored to individual patient needs and symptom clusters. By integrating shared decision-making and self-management support, the program aims to empower patients and caregivers, enhances clinical practice, and contributes substantial evidence to the domain of symptom management in advanced kidney disease. The involvement of stakeholders throughout the research process ensures the relevance and applicability of the findings to real-world clinical settings. .