Abstract / Summary
Abstract Background Patients with permanent pacemakers frequently demonstrate insufficient knowledge and inadequate self-care behaviours, which increase the risk of avoidable post-implantation complications. Structured, theory-informed empowerment protocols may improve these outcomes, yet robust evidence from low- and middle-income countries remains limited. Grounded in Bandura’s self-efficacy theory and a patient-empowerment model, this study evaluated the effect of a nurse-led empowerment protocol on knowledge, practical skills, and self-care behaviours among patients with permanent pacemakers. Methods A non-equivalent control-group, pretest–posttest quasi-experimental design was used and reported in accordance with the Transparent Reporting of Evaluations with Nonrandomized Designs (TREND) statement. Seventy adults with newly implanted permanent pacemakers were recruited from Tanta University Hospitals, Egypt, between December 2025 and April 2026. Because the two arms were recruited in consecutive calendar periods to prevent educational contamination, allocation was non-random and group membership is confounded with time period. The control group ( n = 35) received routine hospital care; the study group ( n = 35) additionally received a structured empowerment protocol (four individual sessions of 30–45 min each, using illustrated Arabic booklets, demonstration and return demonstration, followed by weekly telephone reinforcement during the first month). Three co-primary outcomes were assessed at baseline, immediately post-intervention, and at one-month follow-up: knowledge (Pacemaker-Related Knowledge Questionnaire, 0–20), practice competence (Observational Checklist, 0–50), and self-care behaviour (Self-Care Behaviours Scale, 0–20). Data were analysed using repeated-measures ANOVA (group × time) with Greenhouse–Geisser correction and independent and paired t-tests; a family-wise threshold of α = 0.017 (0.05/3) was applied across the three co-primary group × time tests. Between-group effect sizes and 95% confidence intervals (CIs) were computed. Results The study group improved significantly more than the control group on all three co-primary outcomes. Mean knowledge scores rose from 6.51 ± 2.45 to 15.31 ± 3.46 post-intervention (control: 5.57 ± 2.47 to 7.46 ± 5.60; group × time F(1.43, 97.38) = 148.09, p < 0.001, η² p = 0.685; between-group post-intervention difference 7.85 points, 95% CI 5.67–10.03, Cohen’s d = 1.69). Practice competence improved from 16.29 ± 2.87 to 41.17 ± 10.00 in the study group (control: 14.91 ± 3.33 to 18.54 ± 12.21; F(1.59, 108.12) = 120.34, p < 0.001, η² p = 0.639; difference 22.63, 95% CI 17.40–27.86, d = 2.03). Self-care behaviour scores increased from 13.63 ± 3.11 to 19.00 ± 3.23 in the study group (control: 12.86 ± 2.30 to 15.00 ± 3.10; F(2, 136) = 49.85, p < 0.001, η² p = 0.423; difference 4.00, 95% CI 2.52–5.48, d = 1.26). All three interactions remained significant at the family-wise threshold, and the groups did not differ significantly on any recorded baseline characteristic. Gains were partially sustained at one-month follow-up. Conclusions In this non-randomised study, participants who received a structured, nurse-led empowerment protocol showed substantial and partially sustained gains in knowledge, practical skills, and self-care behaviours, whereas the corresponding gains observed under routine hospital care alone were minimal. Because the two groups were recruited in consecutive calendar periods rather than randomised concurrently, and because outcome assessment was unblinded, these results are best interpreted as an association observed under a quasi-experimental design rather than as causal evidence equivalent to that of a randomised controlled trial. They nonetheless provide a reasonable basis for evaluating systematic, interactive empowerment programmes—incorporating individualised education and scheduled reinforcement—as an addition to routine post-implantation nursing care, and for testing them in randomised, attention-controlled trials with blinded assessment and longer follow-up. Trial registration ClinicalTrials.gov, NCT07743346. Registered on 26 July 2026. Retrospectively registered. Available at: https://clinicaltrials.gov/study/NCT07743346 .