Adaptive nutrition intervention stabilizes serum phosphorus levels in hemodialysis patients: a multi-center decentralized clinical trial using real-world data

Abstract

AbstractObjectiveThis study aims to evaluate the effect of an adaptive nutritional and educational intervention for hemodialysis patients in a routine care setting, using real-world data from electronic health records.MethodsDecentralized clinical trial of seven hemodialysis facilities recruited patients under hemodialysis for over 3 months (N=153) for an 8-week adaptive intervention protocol and divided them into four groups: (1) control (2) education intervention (3) meal intervention (4) education and meal interventions. Educational contents are digitally delivered via mobile phones and pre-made meals tailored on laboratory findings via home delivery. Changes in serum electrolytes and malnutrition inflammation score (MIS) are analyzed.ResultsMeal intervention statistically significantly stabilized serum phosphorus level (β = −0.81) at week 8 with increased likelihood of being in normal range (Odds ratio = 1.21). Meal and education group showed better nutritional status (MIS=3.97) than the control group (MIS=4.57) at week 8 (adjusted p<0.05). No significant changes were observed in serum potassium level, depression, and self-efficacy.ConclusionIt is demonstrated that an adaptive education and meal interventions in a real-world care setting may benefit hemodialysis patients’ serum phosphorus control and nutritional status, without negative effect on depression levels or self-efficacy.