Effectiveness of Integrated Nurse-Led Interventions on Functional Trajectories, Sleep Quality, and Psychological Distress in Hemodialysis Patients: A Six-Month Randomized Controlled Trial
Effectiveness of Integrated Nurse-Led Interventions on Functional Trajectories, Sleep Quality, and Psychological Distress in Hemodialysis Patients: A Six-Month Randomized Controlled Trial
This randomized controlled clinical trial was conducted to evaluate the effectiveness of an integrated nurse-led multidimensional intervention on functional performance, sleep quality, and psychological distress among patients undergoing maintenance hemodialysis in Egypt. A total of 220 patients were randomly assigned to either an intervention group receiving structured nursing care or a control group receiving routine dialysis care. Outcomes were assessed at baseline, 12 weeks, and 6 months. The primary objective was to determine whether the intervention improved functional trajectories, while secondary objectives included evaluating its effects on sleep quality and psychological distress.
End-stage renal disease (ESRD) patients receiving maintenance hemodialysis frequently experience progressive functional decline, impaired sleep quality, and high levels of anxiety and depression. Despite routine dialysis management, these multidimensional burdens remain insufficiently addressed within standard care in Egyptian renal units.
This parallel-group, single-blind randomized controlled trial was conducted in two tertiary governmental hemodialysis centers in Egypt between March 2024 and January 2025. Eligible participants were adults diagnosed with ESRD and receiving hemodialysis for at least six months.
Following baseline assessment, participants (N = 220) were randomly allocated in a 1:1 ratio to:
Intervention group (n = 110): Received a 12-week integrated nurse-led care program including intradialytic functional training, structured sleep optimization counseling, and brief psychological support strategies.
Control group (n = 110): Received routine dialysis care without additional structured interventions.
Inclusion Criteria