Protocol for Developing and Validating the Family Renal Care Readiness Instrument in Chronic Kidney Disease

Background: Chronic kidney disease (CKD) requires long-term home management, including medication adherence, diet and fluid regulation, and symptom monitoring, in which families are often the main partners. Yet no instrument specifically measures family readiness for kidney-related care. Objective: To describe the protocol for developing and validating the Family Renal Care Readiness (FRC-R) instrument, which measures family readiness to care for people with CKD. Methods: This multiphase methodological study follows established scale-development frameworks and the COnsensus-based Standards for the selection of health Measurement INstruments (COSMIN). The phases comprise construct definition, literature review, interviews with family caregivers, patients, and health professionals, item generation, expert content validation, cognitive interviewing, pilot testing, and field testing with approximately 500 family caregivers of adults with CKD stages G3–G5/G5D, at least 100 of whom will complete a test–retest assessment. Analyses will include content validity indices, item analysis, exploratory and confirmatory factor analysis, Cronbach’s alpha, McDonald’s omega, intraclass correlation coefficient, standard error of measurement, and hypothesis testing for construct validity. Results: The conceptual phase produced a 48-item blueprint across eight domains: disease and treatment knowledge; medication and appointments; diet and fluid; symptoms and warning signs; kidney therapy support and safety; communication and psychosocial support; service navigation and digital readiness; and self-efficacy and emergency preparedness. Psychometric data are not yet available. Conclusion: The FRC-R is designed to bridge generic caregiver-preparedness measures and patient-focused self-management instruments. Once validated, it may support readiness screening, tailored family education, and the evaluation of family nursing interventions.