A Self-management Approach for Dietary Sodium Restriction in Patients With CKD: A Randomized Controlled Trial
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.
STUDY DESIGN:Randomized controlled trial.
SETTING & PARTICIPANTS: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.
INTERVENTION: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.
OUTCOMES: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.
RESULTS: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.
LIMITATIONS:Limited power, postrandomization loss to follow-up, Hawthorne effect, lack of dietary data, short-term follow-up.
CONCLUSIONS: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.
FUNDING:Grant funding from the Netherlands Organization for Health Research and Development and the Dutch Kidney Foundation.
TRIAL REGISTRATION:Registered at ClinicalTrials.gov with study number NCT02132013.
CET Conclusion
| Reviewer: | Dr Liset Pengel, Centre for Evidence in Transplantation, Nuffield Department of Surgical Sciences University of Oxford |
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| Conclusion: | The trial evaluated the efficacy of a self-management dietary sodium reduction intervention when compared to routine care in kidney transplant recipients and chronic kidney disease patients (stages 1-4). The randomisation sequence was computer-generated and allocation was concealed by using central randomisation. The web-based self-management dietary sodium reduction intervention consisted of individual e-coaching and group meetings during the 3-month intervention period, which was followed by e-coaching during the next 6 months. The primary outcome was sodium excretion measured using 24-hour urine collection. The sample size calculation showed that 42 patients were required in each group to detect a difference of 2 g/day of salt, achieving 80% power an accounting for a drop-out rate of 10%. Ninety-nine patients were randomised, 89 patients were included in the analysis and 44% of the study population were kidney transplant recipients. At 3 months sodium excretion was significantly lower in the intervention group compared to the routine care group but there was no significant difference at 9 months. The authors also report the outcome of focus group meetings that discussed the barriers and facilitators for implementation of the programme. |
Methodological quality
| Jadad score | 3 |
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| Allocation concealment | YES |
| Data analysis | PER PROTOCOL |
Study Details
| Aims: | To evaluate the efficacy of a self-management intervention for dietary sodium restriction and to explore costs, barriers and facilitators for implementing the intervention. |
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| Interventions: | The SUBLIME (Sodium Burden Lowered by Lifestyle Intervention: Self management and E-health Technology) intervention, which consisted of access to a web-based self-management programme, e-coaching and group counselling versus routine care. |
| Participants: | 99 adult kidney transplant recipients and chronic kidney disease patients (stages 1-4) |
| Outcomes: | The primary outcome sodium excretion was measured using one 24-hour urine collection. Secondary outcomes were blood pressure, costs, proteinuria, health-related quality of life, self-management skills, and evaluation of barriers and facilitators for implementation. |
| Follow Up: | 9 months |
Metadata
| Funding: | Non-industry funding |
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| Publication type: | Randomized Controlled Trial, Randomised Controlled Trial |
| Trial registration: | ClinicalTrials.gov - NCT02132013 |
| Organ: | Kidney |
| Language: | English |
| Author email: | g.klaassen@umcg.nl |
| MeSH terms: | Adult; Diet, Sodium-Restricted; Education, Distance; Female; Glomerular Filtration Rate; Group Processes; Humans; Male; Middle Aged; Outcome Assessment, Health Care; Patient Acuity; Renal Elimination; Renal Insufficiency, Chronic; Self-Management; Sodium Chloride, Dietary; 0 (Sodium Chloride, Dietary); Kidney Transplantation |