Yvette Meuleman1, Tiny Hoekstra2, Friedo W Dekker3, Gerjan Navis4, Liffert Vogt5, Paul J M van der Boog6, Willem Jan W Bos7, Gert A van Montfrans5, Sandra van Dijk8. 1. Department of Health, Medical, and Neuropsychology, Institute of Psychology, Leiden University, Leiden, the Netherlands; Department of Medical Psychology, Leiden University Medical Center, Leiden, the Netherlands. Electronic address: meulemany@fsw.leidenuniv.nl. 2. Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, the Netherlands; Department of Nephrology, VU University Medical Center, Amsterdam, the Netherlands. 3. Department of Clinical Epidemiology, Leiden University Medical Center, Leiden, the Netherlands. 4. Department of Nephrology, University Medical Center Groningen, Groningen, the Netherlands. 5. Department of Internal Medicine, Academic Medical Center, Amsterdam, the Netherlands. 6. Department of Nephrology, Leiden University Medical Center, Leiden, the Netherlands. 7. Department of Internal Medicine, Sint Antonius Hospital, Nieuwegein, the Netherlands. 8. Department of Health, Medical, and Neuropsychology, Institute of Psychology, Leiden University, Leiden, the Netherlands; Department of Nephrology, Leiden University Medical Center, Leiden, the Netherlands.
Abstract
BACKGROUND: To evaluate the effectiveness and sustainability of self-managed sodium restriction in patients with chronic kidney disease. STUDY DESIGN: Open randomized controlled trial. SETTING & PARTICIPANTS: Patients with moderately decreased kidney function from 4 hospitals in the Netherlands. INTERVENTION: Regular care was compared with regular care plus an intervention comprising education, motivational interviewing, coaching, and self-monitoring of blood pressure (BP) and sodium. OUTCOMES: Primary outcomes were sodium excretion and BP after the 3-month intervention and at 6-month follow-up. Secondary outcomes were protein excretion, kidney function, antihypertensive medication, self-efficacy, and health-related quality of life (HRQoL). RESULTS: At baseline, mean sodium excretion rate was 163.6±64.9 (SD) mmol/24 h; mean estimated glomerular filtration rate was 49.7±25.6mL/min/1.73m2; median protein excretion rate was 0.8 (IQR, 0.4-1.7) g/24 h; and mean 24-hour ambulatory systolic and diastolic BPs were 129±15 and 76±9mmHg, respectively. Compared to regular care only (n=71), at 3 months, the intervention group (n=67) showed reduced sodium excretion rate (mean change, -30.3 [95% CI, -54.7 to -5.9] mmol/24 h), daytime ambulatory diastolic BP (mean change, -3.4 [95% CI, -6.3 to -0.6] mmHg), diastolic office BP (mean change, -5.2 [95% CI, -8.4 to -2.1] mmHg), protein excretion (mean change, -0.4 [95% CI, -0.7 to -0.1] g/24h), and improved self-efficacy (mean change, 0.5 [95% CI, 0.1 to 0.9]). At 6 months, differences in sodium excretion rates and ambulatory BPs between the groups were not significant, but differences were detected in systolic and diastolic office BPs (mean changes of -7.3 [95% CI, -12.7 to -1.9] and -3.8 [95% CI, -6.9 to -0.6] mmHg, respectively), protein excretion (mean changes, -0.3 [95% CI, -0.6 to -0.1] g/24h), and self-efficacy (mean change, 0.5 [95% CI, 0.0 to 0.9]). No differences in kidney function, medication, and HRQoL were observed. LIMITATIONS: Nonblinding, relatively low response rate, and missing data. CONCLUSIONS: Compared to regular care only, this self-management intervention modestly improved outcomes, although effects on sodium excretion and ambulatory BP diminish over time.
RCT Entities:
BACKGROUND: To evaluate the effectiveness and sustainability of self-managed sodium restriction in patients with chronic kidney disease. STUDY DESIGN: Open randomized controlled trial. SETTING & PARTICIPANTS: Patients with moderately decreased kidney function from 4 hospitals in the Netherlands. INTERVENTION: Regular care was compared with regular care plus an intervention comprising education, motivational interviewing, coaching, and self-monitoring of blood pressure (BP) and sodium. OUTCOMES: Primary outcomes were sodium excretion and BP after the 3-month intervention and at 6-month follow-up. Secondary outcomes were protein excretion, kidney function, antihypertensive medication, self-efficacy, and health-related quality of life (HRQoL). RESULTS: At baseline, mean sodium excretion rate was 163.6±64.9 (SD) mmol/24 h; mean estimated glomerular filtration rate was 49.7±25.6mL/min/1.73m2; median protein excretion rate was 0.8 (IQR, 0.4-1.7) g/24 h; and mean 24-hour ambulatory systolic and diastolic BPs were 129±15 and 76±9mmHg, respectively. Compared to regular care only (n=71), at 3 months, the intervention group (n=67) showed reduced sodium excretion rate (mean change, -30.3 [95% CI, -54.7 to -5.9] mmol/24 h), daytime ambulatory diastolic BP (mean change, -3.4 [95% CI, -6.3 to -0.6] mmHg), diastolic office BP (mean change, -5.2 [95% CI, -8.4 to -2.1] mmHg), protein excretion (mean change, -0.4 [95% CI, -0.7 to -0.1] g/24h), and improved self-efficacy (mean change, 0.5 [95% CI, 0.1 to 0.9]). At 6 months, differences in sodium excretion rates and ambulatory BPs between the groups were not significant, but differences were detected in systolic and diastolic office BPs (mean changes of -7.3 [95% CI, -12.7 to -1.9] and -3.8 [95% CI, -6.9 to -0.6] mmHg, respectively), protein excretion (mean changes, -0.3 [95% CI, -0.6 to -0.1] g/24h), and self-efficacy (mean change, 0.5 [95% CI, 0.0 to 0.9]). No differences in kidney function, medication, and HRQoL were observed. LIMITATIONS: Nonblinding, relatively low response rate, and missing data. CONCLUSIONS: Compared to regular care only, this self-management intervention modestly improved outcomes, although effects on sodium excretion and ambulatory BP diminish over time.
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