Effects of a Life Hope Program on Self-Care Ability and Hope Levels in Hemodialysis Patients: A Randomized Controlled Trial.

Abstract

Objective: To assess whether the Life Hope Program, when added to routine nursing care, improves self-care ability (primary outcome) and hope levels (co-primary outcome), as well as psychological well-being, nutritional status, quality of life, and complication rates in uremic patients receiving hemodialysis.

Methods: In this randomized controlled trial, 120 uremic hemodialysis patients were assigned to either routine care (control, n=60) or routine care plus a 3-month Life Hope Program (study, n=60). The program integrated goal-setting, psychological support, behavioral and nutritional guidance, cognitive restructuring, and social support. The co-primary endpoints were the Exercise of Self-Care Agency Scale (ESCA) and the Herth Hope Index (HHI). Secondary outcomes included depression (SDS), anxiety (SAS), fatigue (PFS), quality of life (WHOQOL-BREF), nutritional biomarkers (hemoglobin, prealbumin, albumin, transferrin), and complications. Baseline-adjusted analysis of covariance (ANCOVA) was used as the primary analytical method, with adjusted mean differences, 95% confidence intervals (CIs) and Cohen's d effect sizes reported. Bonferroni correction was applied for the two co-primary endpoints to control family-wise Type I error; secondary endpoints are reported with nominal P values and interpreted as exploratory.

Results: All 120 participants completed the study with no dropouts or missing data. At 3 months, the study group showed significantly greater improvement in ESCA (adjusted mean difference 16.4, 95% CI 11.3-21.5, Cohen's d = 1.16, large effect) and HHI (adjusted mean difference 5.7, 95% CI 3.8-7.6, Cohen's d = 1.09, large effect) compared to controls (both P<0.001, below the Bonferroni-corrected threshold of α = 0.025). Significant between-group differences favoring the study group were also observed for SDS (d=1.13), SAS (d=1.28), PFS (d=0.92), and all WHOQOL-BREF domains (all nominal P<0.001; all remained significant after FDR correction). Nutritional biomarkers improved more in the study group (all nominal P<0.01; all remained significant after FDR correction), and risks of vascular access infection (RR 0.12, 95% CI 0.02-0.96), constipation (RR 0.44, 95% CI 0.21-0.94), and dyspepsia (RR 0.45, 95% CI 0.24-0.87) were lower, while urinary tract infection rates did not differ significantly.

Conclusion: The Life Hope Program was associated with significant improvements in self-care ability, hope, psychological well-being, and nutritional status in hemodialysis patients, alongside reductions in fatigue and certain complications. Given the multi-component nature of the intervention, the single-blind design, and the 3-month follow-up period, these promising findings warrant confirmation in attention-controlled trials with longer-term assessment.