Background: Family caregivers of infants with congenital heart defects (CHD) require high health literacy to manage complex postoperative care. However, effective interventions to improve their health literacy are underexplored.Objectives: This study aimed to evaluate the effect of a family-centered care model intervention on the health literacy of family caregivers of pediatric patients following low-risk congenital heart defect surgery.Methods: This quasi experimental study with a before and after design was conducted from January ۲۰۲۰ to December ۲۰۲۵ at Imam Reza Hospital, Mashhad, Iran. A total of ۱۰۰ family caregivers of pediatric patients (under ۲ years) who underwent RACHS (Risk Adjustment for Congenital Heart Surgery) I II surgeries were allocated into experimental (n=۵۰) and control (n=۵۰) groups using block randomization. The experimental group participated in five weekly multimedia family-centered education sessions, while the control group received routine hospital education.
Health literacy was measured using the Health Literacy for Iranian Adults (HELIA) scale at three time points: baseline, immediately post-intervention, and three months’ post-intervention. Data were analyzed using independent t-tests, paired t-tests, and repeated-measures ANOVA in SPSS version ۲۶.۰.Results: A total of ۹۸ caregivers (intervention: n=۴۸, control: n=۵۰) completed the study. The mean age was ۳۹.۳۷±۹.۱۵ years in the intervention group and ۳۷.۱۴±۱۰.۱۱ years in the control group. The majority were mothers (۷۲% in intervention, ۶۸% in control). No significant difference was found between groups in baseline health literacy scores (p=۰.۰۶). Immediately after the intervention, the mean health literacy score in the experimental group was significantly higher than the control group (۵۸.۰۹±۷.۲۴ vs. ۳۱.۴۲±۶.۵۶; p<۰.۰۰۱). This significant difference was maintained at the three-month follow-up (۵۷.۷۲±۶.۱۲ vs. ۳۴.۷۲±۴.۹۸; p<۰.۰۰۱). Repeated measures ANOVA revealed a significant time-by-group interaction (p<۰.۰۰۱), indicating the intervention's effectiveness over time.Conclusion: The family centered care intervention significantly improved health literacy among caregivers of children after low risk CHD surgery, and this effect was sustained at three months. However, given the limited follow up duration, future studies with longer term follow up (≥۱۲ months) are recommended to confirm the durability of the effect.