Feasibility of the COMFORT (COmplex Symptom Management Intervention FOR adulTs With Advanced Kidney Disease) Intervention for Adults With Advanced Kidney Disease and Their Informal Caregivers

Adults with advanced kidney disease may experience a substantial burden of physical andpsychosocial symptoms, including fatigue, drowsiness, pruritus, pain, and restless legs.Multiple symptoms frequently occur at the same time and can negatively affect dailyfunctioning, quality of life, and participation in everyday activities. Informalcaregivers may also experience considerable burden, emotional strain, and uncertaintyabout how best to support the person with advanced kidney disease.Despite the high symptom burden, systematic symptom assessment and management are notconsistently integrated into routine kidney care. Symptom management strategies may focuson individual symptoms rather than addressing multiple co‐occurring symptoms and thebroader needs and preferences of patients and their informal caregivers. Patients andcaregivers may therefore benefit from a more structured approach that supports symptomrecognition and management, shared decision‐making, self‐management, and caregiverinvolvement.The COMFORT Nursing Programme was established in 2023 to address these challenges. Theprogramme has developed a structured, theory‐informed, nurse‐led intervention for symptommanagement in adults with advanced kidney disease. The COMFORT intervention comprisesfour core components: symptom management, shared decision‐making, self‐managementsupport, and caregiver support.The intervention combines systematic symptom assessment using the Integrated Palliativecare Outcome Scale‐Renal (IPOS‐Renal) with an evidence‐based symptom managementdecision‐support tool. Based on the symptoms, needs, and preferences identified by theparticipant, trained nephrology nurses support participants in prioritising symptoms,considering relevant symptom management strategies, participating in shared decisions,and strengthening their ability to manage symptoms in everyday life. Informal caregiversare involved and supported as part of the intervention.In this randomized feasibility study, adults with advanced kidney disease are allocatedin a 1:1 ratio to usual care or usual care supplemented with the COMFORT intervention.The intervention is delivered over approximately 3 months and comprises two structurednurse‐led consultations and one follow‐up telephone consultation.The primary purpose of the study is to evaluate the feasibility and acceptability of theCOMFORT intervention and the procedures required for a future definitive randomisedcontrolled trial. The study will therefore evaluate recruitment and retention,intervention fidelity, acceptability among participants and nephrology nurses, completionand suitability of proposed outcome measures, and the feasibility of study procedures.Patient‐reported and caregiver‐reported measures will also be collected to evaluate theirsuitability for a future trial.The feasibility findings will be used to refine the COMFORT intervention and studyprocedures and to inform the design and conduct of a future multicentre randomisedcontrolled trial evaluating the effectiveness of the COMFORT intervention.