Design and validation of a self-care self-efficacy scale among adolescents with cystic fibrosis in Iran: protocol for...

Self-care self-efficacy is a key determinant of treatment adherence and long-term disease management among adolescents with cystic fibrosis (CF). However, to the best of our knowledge, no culturally specific and psychometrically validated instrument currently exists to assess this construct among Iranian adolescents with CF. This study aims to develop and validate a theory-informed and culturally appropriate scale to measure self-care self-efficacy in this population.

This protocol describes a sequential exploratory mixed-methods study conducted in two phases. Phase I involves qualitative concept development guided by the Hybrid Model of Concept Development and includes an integrative literature review, semistructured interviews with approximately 15-20 adolescents with CF, and analytical integration to refine the conceptual definition and identify measurable indicators. Phase II focuses on scale development and psychometric evaluation. Items derived from qualitative findings will be assessed for face and content validity. Construct validity will be examined using exploratory factor analysis with about 200 adolescents consecutively recruited from two specialised CF referral clinics located in Mashhad and Ahvaz. Reliability will be evaluated using Cronbach's alpha and test-retest intraclass correlation coefficients. Quantitative analyses will be conducted using SPSS V 29.

Ethical approval has been obtained from the Ethics Committee of Mashhad University of Medical Sciences (IR.MUMS.NURSE.REC.1403.093). Written informed assent and parental consent will be obtained from all participants. Findings will be disseminated through peer-reviewed publications and conference presentations to inform clinical assessment and intervention planning for adolescents with CF.