Abstract
Patients with chronic kidney disease (CKD) are particularly sensitive to dietary sodium. We evaluated a self-management approach for dietary sodium restriction in patients with CKD. Randomized controlled trial. Nephrology outpatient clinics in 4 Dutch hospitals. 99 adults with CKD stages 1 to 4 or a functioning (estimated glomerular filtration rate≥25mL/min/1.73m2) kidney transplant, hypertension, and sodium intake>130mmol/d. Routine care was compared with routine care plus a web-based self-management intervention including individual e-coaching and group meetings implemented over a 3-month intervention period, followed by e-coaching over a 6-month maintenance period. Primary outcomes were sodium excretion after the 3-month intervention and after the 6-month maintenance period. Secondary outcomes were blood pressure, proteinuria, costs, quality of life, self-management skills, and barriers and facilitators for implementation. Baseline estimated glomerular filtration rate was 55.0±22.0mL/min/1.73m2. During the intervention period, sodium excretion decreased in the intervention group from 188±8 (SE) to 148±8mmol/d (P<0.001), but did not change significantly in the control group. At 3 months, mean sodium excretion was 24.8 (95% CI, 0.1-49.6) mmol/d lower in the intervention group (P=0.049). At 3 months, systolic blood pressure (SBP) decreased in the intervention group from 140±3 to 132±3mm Hg (P<0.001), but was unchanged in the control group. Mean difference in SBP across groups was-4.7 (95% CI,-10.7 to 1.3) mm Hg (P=0.1). During the maintenance phase, sodium excretion increased in the intervention group, but remained lower than at baseline at 160±8mmol/d (P=0.01), while it decreased in the control group from 174±9 at the end of the intervention period to 154±9mmol/d (P=0.001). Consequently, no difference in sodium excretion between groups was observed after the maintenance phase. There was no difference in SBP between groups after the maintenance phase. Limited power, postrandomization loss to follow-up, Hawthorne effect, lack of dietary data, short-term follow-up. A coaching intervention reduced sodium intake at 3 months. Efficacy during the maintenance phase was diminished, possibly due to inadvertent adoption of the intervention by the control group. Grant funding from the Netherlands Organization for Health Research and Development and the Dutch Kidney Foundation. Registered at ClinicalTrials.gov with study number NCT02132013.
Highlights
Rationale & Objective: Patients with chronic kidney disease (CKD) are sensitive to dietary sodium
Sodium excretion decreased in the intervention group from 188 ± 8 (SE) to 148 ± 8 mmol/d (P < 0.001), but did not change significantly in the control group
Mean difference in systolic blood pressure (SBP) across groups was −4.7 mm Hg (P = 0.1)
Summary
We randomly assigned 99 patients: 52 intervention and 47 control (Fig 2). Five patients did not attend the baseline measurement visit. The effect on sodium excretion persisted in the intervention group, being 157 ± 64 mmol/d after the 6month maintenance phase (Fig 3). LMM confirmed this, with the estimated marginal mean changing from 188 ± 8 mmol/d at baseline to 160 ± 8 mmol/d at 9 months postbaseline (P = 0.01 for within-group difference; Table 2). There was a decrease to 154 ± 40 mmol/d at 9 months postbaseline (Fig 3) This is reflected in the LMM (Table 2), leading to no significant between-group difference in sodium excretion between the intervention and control groups (Table 2). A few participants reported using the program longer than 6 months, which is supported by the data logs Most participants recorded their dietary intake in the evenings. The providers believed that they were capable of doing the activities needed to carry out the SUBLIME intervention
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