The NKF-NUS hemodialysis trial protocol - a randomized controlled trial to determine the effectiveness of a self management intervention for hemodialysis patients Nutritional education for management of osteodystrophy (NEMO) trial: Design and patient characteristics, Lebanon Nutritional education for the management of osteodystrophy (nemo) in patients on haemodialysis: a randomised controlled trial. Potentially modifiable factors associated with non-adherence to phosphate binder use in patients on hemodialysis The effects of frequent nocturnal home hemodialysis: the Frequent Hemodialysis Network Nocturnal Trial. Effect of food additives on hyperphosphatemia among patients with end-stage renal disease: a randomized controlled trial. More Dietetic Time, Better Outcome? A Pilot Randomized Trial of Financial Incentives or Coaching to Lower Serum Phosphorus in Dialysis Patients. A cognitive behavioral group approach to enhance adherence to hemodialysis fluid restrictions: a randomized controlled trial. Evaluation of a phosphate management protocol to achieve optimum serum phosphate levels in hemodialysis patients. Teaching program effects on high phosphorus levels in patients receiving hemodialysis. Phosphate binder use and mortality among hemodialysis patients in the Dialysis Outcomes and Practice Patterns Study (DOPPS): evaluation of possible confounding by nutritional status. Comparison of dietary phosphate absorption after single doses of lanthanum carbonate and sevelamer carbonate in healthy volunteers: a balance study. Dietary and fluid compliance: an educational intervention for patients having haemodialysis. Results of a pilot program to improve phosphorus outcomes in hemodialysis patients. Patient Education: An Efficient Adjuvant Therapy for Hyperphosphatemia in Hemodialysis Patients Effectiveness of a nurse-led intensive educational programme on chronic kidney failure patients with hyperphosphataemia: randomised controlled trial. The effectiveness of education or behavioral interventions on adherence to phosphate control in adults receiving hemodialysis: a systematic review protocol Effect of behavioral stage-based nutrition education on management of osteodystrophy among hemodialysis patients, Lebanon.
Background Poor adherence to treatment is common in patients on hemodialysis which may increase risk for poor clinical outcomes and mortality . Self management interventions have been shown to be effective in improving compliance in other chronic population s. The aim of this trial is to evaluate the effectiveness of a recently developed group based self management intervention for hemodialysis patients compared to st and ard care . Methods / Design This is a multicentre parallel arm block r and omized controlled trial ( RCT ) of a four session group self management intervention for  hemodialysis patients delivered by health care professionals compared to st and ard care .  A total of 176 consenting adults maintained on hemodialysis for a minimum of 6 months will be r and omized to receive the self management intervention or st and ard care . Primary outcomes are biochemical markers of clinical status and adherence . Secondary outcomes include general health related quality of life , disease-specific quality of life , mood , self efficacy and self-reported adherence . Outcomes will be measured at baseline , immediately post-intervention and at 3 and 9 months post-intervention by an independent assessor and analysed on intention to treat principles with linear mixed-effects models across all time points . A qualitative component will examine which aspects of program participants found particularly useful and any barriers to change . Discussion The NKF-NUS intervention builds upon previous research emphasizing the importance of empowering patients in taking control of their treatment management . The trial design addresses weaknesses of previous research by use of an adequate sample size to detect clinical ly significant changes in biochemical markers , recruitment of a sufficiently large representative sample , a theory based intervention and careful assessment of both clinical and psychological endpoints at various follow up points . Inclusion of multiple dependent variables allows us to assess the broader impact on the intervention including both hard end points as well as patient reported outcomes . This program , if found to be effective , has the potential to be implemented within the existing renal services delivery model in Singapore , particularly as this is being delivered by health care professionals already working with hemodialysis patients in these setting s who are specifically trained in facilitating self management in renal patients .Trial registration Current Controlled Trials This study aims to determine the effect of a trained dedicated dietitian on clinical outcomes among Lebanese hemodialysis ( HD ) patients : and thus demonstrate a viable developing country model . This paper describes the study protocol and baseline data . The study was a multicenter r and omized controlled trial with parallel-group design involving 12 HD units : assigned to cluster A ( n = 6 ) or B ( n = 6 ) . A total of 570 patients met the inclusion criteria . Patients in cluster A were r and omly assigned as per dialysis shift to the following : Dedicated Dietitian ( DD ) ( n = 133 ) and Existing Practice ( EP ) ( n = 138 ) protocol s. Cluster B patients ( n = 299 ) received Trained Hospital Dietitian ( THD ) protocol . Dietitians of the DD and THD groups were trained by the research team on Kidney Disease Outcomes Quality Initiative nutrition guidelines . DD protocol included : individualized nutrition education for 2 hours/month/HD patient for 6 months focusing on renal osteodystrophy and using the Trans-theoretical theory for behavioral change . EP protocol included nutrition education given to patients by hospital dietitians who were blinded to the study . The THD protocol included nutrition education to patients given by hospital dietitian as per the training received but within hospital responsibilities , with no set educational protocol or tools . Baseline data revealed that 40 % of patients were hyperphosphatemics ( > 5.5 mg/dl ) with low dietary adherence and knowledge of dietary P restriction in addition to inadequate daily protein intake ( 58.86%± 33.87 % of needs ) yet adequate dietary P intake ( 795.52 ± 366.94 mg/day ) . Quality of life ( QOL ) ranged from 48 - 75 % of full health . Baseline differences between the 3 groups revealed significant differences in serum P , malnutrition status , adherence to diet and P chelators and in 2 factors of the QOL : physical and social functioning . The data show room for improvement in the nutritional status of the patients . The NEMO trial may be able to demonstrate a better nutritional management of HD patients OBJECTIVE To examine the effect of self-management dietary counselling ( SMDC ) on adherence to dietary management of hyperphosphatemia among haemodialysis patients . DESIGN An eight-week cluster based r and omised control trial . PARTICIPANTS 122 stable adult patients were recruited from an HD unit in Sidon , Lebanon . Study groups were : full intervention ( A ) ( n = 41 ) , partial intervention ( B ) ( n = 41 ) and control ( C ) ( n = 40 ) . INTERVENTION Group ( A ) received SMDC , Group ( B ) received educational games only and Group ( C ) did not receive any research intervention . MAIN OUTCOME MEASURES Serum phosphorus ( P ) , Calcium Phosphate product ( Ca × P ) and two question naires : patient knowledge ( PK ) and dietary non-adherence ( PDnA ) to P reduced diet . RESULTS Group A experienced a significant improvement in mean ( ± SD ) P ( 6.54 ± 2.05 - 5.4 ± 1.97 mg/dl ) , Ca × P ( 58 ± 17 - 49 ± 12 ) , PK scores ( 50 ± 17 - 69 ± 25 % ) and PDnA scores ( 21.4 ± 4.0 - 18.3 ± 2.0 ) . Group B experienced a significant improvement in Ca × P ( 52 ± 14 - 45 ± 16 ) . Group C did not experience any significant change post intervention . CONCLUSION Our findings demonstrate the importance of patient-tailored counselling on serum P management Background Despite the evidence that phosphate binder ( PB ) is associated with improved outcomes many hemodialysis patients do not adhere to prescribed PB regimen . Therefore , barriers to PB adherence should be identified and eliminated . The purpose of this study was to evaluate PB adherence  among hemodialysis patients and to explore potentially modifiable factors associated with low PB adherence . Methods A cross-sectional study ( 502 patients ) was performed in four dialysis units in Salvador , Brazil , using data from the second phase of the Prospect i ve Study of the Prognosis of Chronic Hemodialysis Patients ( PROHEMO ) . Patients were categorized as adherent or non-adherent to PB based on their responses to a semi-structured question naire . Results Non-adherence to PB  was observed for 65.7 % of the patients . After adjustments for numerous covariates , cerebrovascular disease ( odds ratio ( OR ) , 3.30 ; 95 % confidence interval ( CI ) , 1.03 - 10.61 ) , higher PTH ( OR per each 300 pg/mL , 1.14 ; 95 % CI , 1.01 - 1.28 ) , lack of comprehension of the appropriate time to use PB ( OR , 7.09 ; 95 % CI , 2.10 - 23.95 ) and stopping PB use after feeling better ( OR , 4.54 ; 95 % CI , 1.45 - 14.25 ) or feeling worse ( OR , 11.04 ; 95 % CI , 1.79- 68.03 ) were significantly associated with PB non-adherence . By contrast , the adjusted odds of PB non-adherence were lower for patients with more years on dialysis ( OR by each 2 years , 0.87 ; 95 % CI , 0.80 - 0.95 ) , with serum phosphorus above 5.5 mg/dL ( OR , 0.53 ; 95 % CI 0.34 - 0.82 ) , who referred that were encouraged by the dialysis staff to be independent ( OR , 0.52 ; 95 % CI 0.30 - 0.90 ) , and reported that the nephrologist explained how PB should be used ( OR , 0.20 ; 95 % CI 0.05 - 0.73 ) . Conclusion The results of the present study are encouraging by showing evidence that improvement in the care provided by the dialysis staff and the attending nephrologist may play an important role in reducing the high prevalence of non-adherence to PB in maintenance hemodialysis patients . A new question naire is presented and may help to evaluate systematic ally the patients regarding PB adherence in hemodialysis setting Prior small studies have shown multiple benefits of frequent nocturnal hemodialysis compared to conventional three times per week treatments . To study this further , we r and omized 87 patients to three times per week conventional hemodialysis or to nocturnal hemodialysis six times per week , all with single-use high-flux dialyzers . The 45 patients in the frequent nocturnal arm had a 1.82-fold higher mean weekly stdKt/V(urea ) , a 1.74-fold higher average number of treatments per week , and a 2.45-fold higher average weekly treatment time than the 42 patients in the conventional arm . We did not find a significant effect of nocturnal hemodialysis for either of the two co primary outcomes ( death or left ventricular mass ( measured by MRI ) with a hazard ratio of 0.68 , or of death or R AND Physical Health Composite with a hazard ratio of 0.91 ) . Possible explanations for the left ventricular mass result include limited sample size and patient characteristics . Secondary outcomes included cognitive performance , self-reported depression , laboratory markers of nutrition , mineral metabolism and anemia , blood pressure and rates of hospitalization , and vascular access interventions . Patients in the nocturnal arm had improved control of hyperphosphatemia and hypertension , but no significant benefit among the other main secondary outcomes . There was a trend for increased vascular access events in the nocturnal arm . Thus , we were unable to demonstrate a definitive benefit of more frequent nocturnal hemodialysis for either co primary outcome CONTEXT High dietary phosphorus intake has deleterious consequences for renal patients and is possibly harmful for the general public as well . To prevent hyperphosphatemia , patients with end-stage renal disease limit their intake of foods that are naturally high in phosphorus . However , phosphorus-containing additives are increasingly being added to processed and fast foods . The effect of such additives on serum phosphorus levels is unclear . OBJECTIVE To determine the effect of limiting the intake of phosphorus-containing food additives on serum phosphorus levels among patients with end-stage renal disease . DESIGN , SETTING , AND PARTICIPANTS Cluster r and omized controlled trial at 14 long-term hemodialysis facilities in northeast Ohio . Two hundred seventy-nine patients with elevated baseline serum phosphorus levels ( > 5.5 mg/dL ) were recruited between May and October 2007 . Two shifts at each of 12 large facilities and 1 shift at each of 2 small facilities were r and omly assigned to an intervention or control group . INTERVENTION  Intervention participants ( n=145 ) received education on avoiding foods with phosphorus additives when purchasing groceries or visiting fast food restaurants . Control participants ( n=134 )  continued to receive usual care . MAIN OUTCOME MEASURE Change in serum phosphorus level after 3 months . RESULTS At baseline , there was no significant difference in serum phosphorus levels between the 2 groups . After 3 months , the decline in serum phosphorus levels was 0.6 mg/dL larger among intervention vs control participants ( 95 % confidence interval , -1.0 to -0.1 mg/dL ) . Intervention participants also had statistically significant increases in reading ingredient lists ( P<.001 ) and nutrition facts labels ( P = .04 ) but no significant increase in food knowledge scores ( P = .13 ) . CONCLUSION Educating end-stage renal disease patients to avoid phosphorus-containing food additives result ed in modest improvements in hyperphosphatemia . TRIAL REGISTRATION clinical trials.gov Identifier : NCT00583570 Background / Aim : A r and omized controlled trial was conducted involving 67 stable adult haemodialysis patients with hyperphosphataemia . The objective was to determine the effect of monthly dietetic consultations on patients ’ serum phosphate concentrations and calcium × phosphate product . Methods : The intervention group received monthly dietetic consultations for 6 months using advanced counselling skills aim ed at limiting phosphate intake in the diet and improving compliance with phosphate binders , whereas st and ard care with dietetic consultations every 6 months was provided to the control group .  Results : Serum phosphate concentrations decreased in the intervention group from 2.05 ± 0.48 to 1.80 ± 0.48 mmol/l by month 3 ( p < 0.05 ) . However , this subsequently increased and by month 6 there was no significant difference from baseline . After controlling for confounding variables , the difference between the groups was approaching significance at month 3 , but there was no difference by month 6 , or following conclusion of the study . The calcium × phosphate product similarly decreased in both groups , achieving K/DOQI st and ards , but was not sustained either during the remainder of the study but decreased further by the 12-month follow-up and , although it was not significantly different , it did improve significantly from baseline in both the intervention and control groups . Conclusion : Increased frequency of dietetic consultations can result in improved phosphate control in the short term , and therefore more innovative strategies appear necessary to sustain longer-term control OBJECTIVE Among chronic hemodialysis patients , hyperphosphatemia is common and associated with mortality . Behavioral economics and complementary behavior-change theories may offer valuable approaches to achieving phosphorus ( PO4 ) control . The aim was to determine feasibility of implementing financial incentives and structured coaching to improve PO4 in the hemodialysis setting . DESIGN AND METHODS This pilot r and omized controlled trial was conducted in 3 urban dialysis units for 10 weeks among 36 adults with elevated serum PO4 ( median > 5.5 mg/dL over 3 months ) . INTERVENTIONS Twelve participants each were r and omized to : ( 1 ) financial incentives for lowering PO4 , ( 2 ) coaching about dietary and medication adherence , or ( 3 ) usual care . PO4 was measured during routine clinic operations . Each incentives arm participant received the equivalent of $ 1.50/day if the PO4 was ≤5.5 mg/dL or > 5.5 mg/dL but decreased ≥0.5 mg/dL since the prior measurement . The coach was instructed to contact coaching arm participants at least 3 times per week . MAIN OUTCOME MEASURES The outcome measures included : ( 1 ) enrollment rate , ( 2 ) dropout rate , and ( 3 ) change in PO4 from beginning to end of 10-week intervention period . RESULTS Of 66 eligible patients , 36 ( 55 % ) enrolled . Median age was 53 years , 83 % were black race , and 78 % were male . Median baseline PO4 was 6.0 ( interquartile range 5.6 , 7.5 ) . Using stratified generalized estimation equation analyses , the monthly decline in PO4 was -0.32 mg/dL ( 95 % CI -0.60 , -0.04 ) in the incentives arm , -0.40 mg/dL ( -0.60 , -0.20 ) in the coaching arm , and -0.24 mg/dL ( -0.60 , 0.08 ) in the usual care arm . No patients dropped out . All intervention arm participants expressed interest in receiving similar support in the future . CONCLUSIONS This pilot trial demonstrated good feasibility in enrollment and implementation of novel behavioral health strategies to reduce PO4 in dialysis patients BACKGROUND Adhering to fluid restrictions represents one of the most difficult aspects of the hemodialysis treatment regimen . This report describes a r and omized controlled trial of a group-based cognitive behavioral intervention aim ed at improving fluid-restriction adherence in patients receiving hemodialysis . It was hypothesized that the intervention would improve adherence , measured by means of interdialytic weight gain ( IWG ) , without impacting negatively on psychosocial functioning . METHODS Fifty-six participants receiving hemodialysis from 4 renal outpatient setting s were r and omly assigned to an immediate-treatment group ( ITG ; n = 29 ) or deferred-treatment group ( DTG ; n = 27 ) . Participants were assessed at baseline , posttreatment , and follow-up stages . Treatment consisted of a 4-week intervention using educational , cognitive , and behavioral strategies to enhance effective self-management of fluid consumption . RESULTS No significant difference in mean IWGs was found between the ITG and DTG during the acute-phase analysis ( F(1,54 ) = 0.03 ; P > 0.05 ) . However , in longitudinal analysis , there was a significant main effect for mean IWG ( F(1.76,96.80 ) = 9.10 ; P < 0.001 ) and a significant difference between baseline and follow-up IWG values ( t55 = 3.85 ; P < 0.001 ) , reflecting improved adherence over time . No adverse effects of treatment were indicated through measures of psychosocial functioning . Some significant changes were evidence d in cognitions thought to be important in mediating behavioral change . CONCLUSION The current study provides evidence for the feasibility and effectiveness of applying group-based cognitive behavior therapy to enhance adherence to hemodialysis fluid restrictions . Results are discussed in the context of the study 's method ological limitations OBJECTIVE To evaluate the effectiveness of a protocol design ed to optimize serum phosphate levels in patients undergoing regular hemodialysis ( HD ) . DESIGN R and omized , controlled trial . SETTING Hemodialysis units at Barts and the London NHS Trust and satellite units . PATIENTS Thirty-four clinical ly stable adults undergoing regular HD with a serum phosphate level > 1.8 mmol/L on at least one occasion within 4 months of starting the study . INTERVENTION Management of serum phosphate using a specially design ed phosphate management protocol during a 4-month study period implemented by a renal dietitian and renal pharmacist compared with st and ard practice . MAIN OUTCOME MEASURE Change in serum phosphate levels in both groups after 4 months . RESULTS Patients managed using the phosphate management protocol had a significantly greater reduction in serum phosphate levels compared with patients receiving st and ard practice ( -0.22 + /- 0.67 mmol/L vs. + 0.19 + /- 0.32 mmol/L , P = 0.03 ) . CONCLUSION The phosphate management protocol was effective , and its implementation was associated with significantly better serum phosphate control in patients undergoing regular HD OBJECTIVE The objective was to determine the effect of a patient education intervention on decreasing serum phosphorus levels , increasing calcium levels , and increasing knowledge in hemodialysis patients with abnormally high phosphorus levels ( n = 29 ) . SAMPLE / SETTING Study subjects were ( a ) on hemodialysis at least 3 months , ( b ) English speaking , ( c ) mentally alert , ( d ) not under constant nursing care , and ( e ) hyperphosphatemic . The study was conducted at two suburban dialysis units in the Chicago Metropolitan area . DESIGN This study had a one group , pretest-posttest design , using subjects as their own controls . METHODS The intervention was a one-on-one education session performed by a nephrology nurse using a teaching booklet , an Osteodystrophy Tool , and a medication diary . RESULTS The mean change score for phosphorus did not reach significance ( t [ 28 ] = .68 , p = .50 ) . The change in mean phosphorus levels was not related to gender , education , or dialysis unit . There was a weak relationship between a decrease in phosphorus and an increase in knowledge about phosphorus ( r = 0.21 ) . However , calcium levels improved significantly after the teaching intervention ( t [ 28 ] = 3.23 , p = 0.003 ) . Mean overall scores for knowledge about phosphorus control increased significantly also ( t [ 28 ] = 2.60 , p = < 0.01 ) . CONCLUSION The findings of this study demonstrated that an education session can have an effect on patients ' knowledge and compliance BACKGROUND Poor nutritional status and both hyper- and hypophosphatemia are associated with increased mortality in maintenance hemodialysis ( HD ) patients . We assessed associations of phosphate binder prescription with survival and indicators of nutritional status in maintenance HD patients . STUDY DESIGN Prospect i ve cohort study ( DOPPS [ Dialysis Outcomes and Practice Patterns Study ] ) , 1996 - 2008 . SETTING & PARTICIPANTS 23,898 maintenance HD patients at 923 facilities in 12 countries . PREDICTORS Patient-level phosphate binder prescription and case-mix-adjusted facility percentage of phosphate binder prescription using an instrumental-variable analysis . OUTCOME All-cause mortality . RESULTS Overall , 88 % of patients were prescribed phosphate binders . Distributions of age , comorbid conditions , and other characteristics showed small differences between facilities with higher and lower percentages of phosphate binder prescription . Patient-level phosphate binder prescription was associated strongly at baseline with indicators of better nutrition , ie , higher values for serum creatinine , albumin , normalized protein catabolic rate , and body mass index and absence of cachectic appearance . Overall , patients prescribed phosphate binders had 25 % lower mortality ( HR , 0.75 ; 95 % CI , 0.68 - 0.83 ) when adjusted for serum phosphorus level and other covariates ; further adjustment for nutritional indicators attenuated this association ( HR , 0.88 ; 95 % CI , 0.80 - 0.97 ) . However , this inverse association was observed for only patients with serum phosphorus levels ≥3.5 mg/dL. In the instrumental-variable analysis , case-mix-adjusted facility percentage of phosphate binder prescription ( range , 23%-100 % ) was associated positively with better nutritional status and inversely with mortality ( HR for 10 % more phosphate binders , 0.93 ; 95 % CI , 0.89 - 0.96 ) . Further adjustment for nutritional indicators reduced this association to an HR of 0.95 ( 95 % CI , 0.92 - 0.99 ) . LIMITATIONS Results were based on phosphate binder prescription ; phosphate binder and nutritional data were cross-sectional ; dietary restriction was not assessed ; observational design limits causal inference due to possible residual confounding . CONCLUSIONS Longer survival and better nutritional status were observed for maintenance HD patients  prescribed phosphate binders and in facilities with a greater percentage of phosphate binder prescription . Underst and ing the mechanisms for explaining this effect and ruling out possible residual confounding require additional research BACKGROUND Lanthanum carbonate and sevelamer carbonate are noncalcium phosphate binders used to treat hyperphosphatemia in patients with chronic kidney disease . This is the first study to compare phosphate absorption from a st and ardized meal ingested with a typical clinical dose of these binders . STUDY DESIGN R and omized open-label crossover study . SETTING S & PARTICIPANTS Healthy volunteers were confined to a clinical research center during 4 study periods . Of 31 volunteers r and omly assigned , 19 completed all treatments and 18 were analyzed in the pharmacodynamic set ( 1 was excluded because of vomiting ) . INTERVENTION Participants were assigned in r and om order to meal alone , meal plus lanthanum carbonate ( 1 tablet containing 1,000 mg of elemental lanthanum ) , and meal plus sevelamer carbonate ( three 800-mg tablets ) . The gastrointestinal tract was cleared , the meal was ingested ( ± treatment ) , and rectal effluent was collected . In a fourth period , volunteers repeated the study procedures while fasting . OUTCOMES The primary end point , net phosphate absorption , was analyzed using a mixed-effect linear model . MEASUREMENTS Phosphorus content of effluent and duplicate meal sample s were measured using inductively coupled plasma-optical emission spectroscopy . RESULTS The st and ard meal contained ∼375 mg of phosphate , 75 % of which was absorbed ( net absorption , 281.7 ± 14.1 mg [ adjusted mean ± st and ard error ] ) . Lanthanum carbonate decreased net phosphate absorption by 45 % ( net absorption , 156.0 ± 14.2 mg ) compared with 21 % ( net absorption , 221.8 ± 14.1 mg ) for sevelamer carbonate ( P < 0.001 ) . Lanthanum carbonate bound 135.1 ± 12.3 mg of phosphate , whereas sevelamer carbonate bound 63.2 ± 12.3 mg , a 71.9-mg difference ( 95 % CI , 40.0 - 103.8 ; P < 0.001 ) . Per tablet , this equates to 135 mg of phosphate bound with lanthanum carbonate versus 21 mg with sevelamer carbonate . LIMITATIONS A single-dose study . CONCLUSIONS In healthy volunteers , 1,000 mg of lanthanum carbonate decreased phosphate absorption by 45 % compared with a 21 % decrease with 2,400 mg of sevelamer carbonate AIM This paper is a report of a study conducted to determine the effect of an educational intervention on dietary and fluid compliance in patients having haemodialysis . BACKGROUND Many of the clinical problems experienced by patients having haemodialysis are related to their failure to eat appropriate foods and restrict their fluid intake . Educational intervention in patients having haemodialysis to improve their compliance with dietary and fluid restrictions appears to be effective . METHODS Sixty-three patients having haemodialysis in three general hospitals in Tehran , Iran , were allocated into two groups at r and om for oral and /or video education . They were asked to give demographic and medical data . Bimonthly average values of serum potassium , sodium , calcium , phosphate , albumin , creatinine , uric acid , and blood urea nitrogen and interdialytic weight gain were measured before and after the teaching programmes . The data were collected in 2007 . FINDINGS Compliance in terms of biochemical parameters and interdialytic weight gain was observed in 63.5 % and 76.2 % of patients in the oral and video teaching groups respectively . Statistically significant correlations were observed between demographic variables ( age , educational level and occupation ) and dietary and fluid compliances ( P < 0.001 ) . There was no difference between the effectiveness of two educational interventions . CONCLUSION Nurses should emphasize sodium compliance in patients having haemodialysis and explain its adverse effects , such as excessive weight gain , hypertension , and peripheral oedema OBJECTIVE End-stage renal disease causes dysregulation of bone and mineral metabolism , including increased serum phosphorus levels . Kidney Foundation Kidney Disease Outcome Quality Initiative 2003 guidelines recommend maintaining phosphorus levels between 3.5 and 5.5 mg/dL in dialysis patients . We examined the effects of a focused phosphorus management pilot program design ed to improve the percentage of hemodialysis patients achieving phosphorus levels < 5.5 mg/dL. DESIGN , SETTING , SUBJECTS , AND INTERVENTION : We conducted a prospect i ve , multicenter , single-arm study at 8 geographically diverse at-risk facilities ( n = 702 hemodialysis patients ) in a large U.S. dialysis organization . The focused phosphorus management program provided in-service training to staff members , and provided patients with diet and phosphorus management through in-center , 1:1 education and support , direct-to-patient adherence communications , benefit management assistance , and adherence support specific to lanthanum carbonate over a 6-month period . MAIN OUTCOME MEASURE Facility-level markers of bone and mineral metabolism ( phosphorus , parathyroid hormone , corrected calcium ) and nutritional status ( serum albumin , normalized protein catabolic rate ) were assessed before and after program implementation . RESULTS There was a significant increase in the percentage of patients per facility achieving phosphorus levels < 5.5 mg/dL ( mean ± SD at baseline = 61.6 % ± 5.2 % ; month 6 = 71.3 % ± 9.0 % ; P < .01 ) and parathyroid hormone ( 150 to 300 pg/mL ; mean ± SD at baseline = 39.1 % ± 2.4 % ; month 6 = 44.5 % ± 7.0 % ; P = .04 ) . During the course of the evaluation , mean calcium , albumin , and normalized protein catabolic rate levels did not change significantly . CONCLUSIONS These results show proof-of-concept that a focused phosphorus management program targeting both staff members and patients can significantly improve patient outcomes without compromising nutritional status Background . Hemodialysis and phosphate ( P ) binder therapy are the major methods to reduce the phosphate level in dialysis patients . However , dietary P restriction is necessary for adequate control . The successful dietary control is based on patient compliance . Patient education is the best method to assure the knowledge and drive of dietary control , which are the key features for patient compliance . The aim of the study is to investigate quantitatively the effect of patient education on serum P levels in hyperphosphatemic hemodialysis patients . Methods . We conducted a prospect i ve self-control study . Fifty hemodialysis patients with a pre-dialysis serum P level greater than 6.0 mg/dL were studied .  Intensified patient education was given . Serum P , calcium ( Ca ) , and intact parathyroid hormone ( iPTH ) were evaluated before and one month after patient education . Results . Thirty-six ( 72 % ) patients had improved pre-dialysis P level ( pre-education : 7.50 ± 1.33 ; post-education : 5.85 ± 1.20 mg/dL , p < 0.001 ) and Ca × P product ( pre-education : 68.17 ± 12.70 ; post-education : 54.70 ± 11.87 mg2/dL2 , p < 0.001 ) . The effect lasted for at least three months . There is no significant change on calcium levels . The only predictor of a successful patient education is the iPTH level ( improved : 348.8 ± 277.6 ; non-improved : 668.0 ± 674.1 ng/mL , p = 0.021 ) . Conclusions . Patient education could be helpful and efficient in hyperphosphatemic control in dialysis patients . The patient education should be given before the serum iPTH level getting high AIMS AND OBJECTIVES To prospect ively evaluate the effects of a nurse-led educational intervention on the management of hyperphosphataemia as well as knowledge of phosphate among patients with end-stage renal disease . BACKGROUND Haemodialysis and phosphate binder therapy are the major methods used to reduce the phosphate level in dialysis patients . However , patient education related to hyperphosphataemia , diet and phosphate binders may be another important factor associated with the success of the control of the hyperphosphataemia . DESIGN This prospect i ve r and omised controlled trial was conducted during the period from June 2009-March 2011 at the HD units of two hospitals in Tianjin , China . METHODS A total of 80 participants were r and omly assigned to experimental group ( n=40 ) and control group ( n=40 ) . Participants in the experimental group received the nurse-led intensive educational programme , including individualised education and educational session about diet and medicine regimes , etc . , while participants in the control group received the routine guidance . RESULTS There were statistically significant differences between the study groups in decline in serum phosphorus and calcium-phosphorus product levels and improvement in patients ' general knowledge three months postintervention , and these differences sustained until the end of the study . Increased serum calcium level was observed both in the experimental group and in the control group , but there was no significant difference between groups . No statistical significance was found regarding serum albumin level between the groups . No significant difference in the serum parathyroid hormone level was found between the groups by month 6 . CONCLUSIONS Nurse-led intensive educational programme plays an important role in the control of hyperphosphataemia among patients with end-stage renal disease . RELEVANCE TO CLINICAL PRACTICE Chronic kidney failure patients with hyperphosphataemia are more likely to benefit from nurse-led intensive educational programmes Review question / objective The objective of this review is to identify the effectiveness of education or behavioral interventions on adherence to phosphate control in adults with end stage kidney disease ( ESKD ) receiving hemodialysis ( HD ) . Background Hyperphosphatemia occurs in people with ESKD as a result of the kidneys ' reduced ability to excrete an ingested phosphate load.1,2 Hyperphosphatemia significantly lowers the serum calcium concentration , stimulating the release of parathyroid hormone ( PTH ) , causing secondary hyperparathyroidism.3–6 In ESKD , hyperphosphatemia also slows the activation of vitamin D which leads to impaired absorption of calcium from the gastrointestinal tract , result ing in reduced mobilization of calcium and phosphate from the bones , and causing metabolic bone disease.2,6,7 The reduced mobilization of both phosphate and calcium enables these two minerals to bind together creating a calcium‐phosphate product . At a serum concentration of > 1.78mmol/L the calcium‐phosphate product crystallizes and is deposited within the soft tissue and vasculature.6,8,9 In ESKD the development of vascular calcification of the arterial media ( i.e. calciphylaxis ) is a major contributing factor of morbidity and mortality.4,5,9,10 Methods of phosphate control Hyperphosphatemia is a wellrecognized risk factor for renal osteodystrophy and cardiovascular mortality in people with ESKD.1,4,11 Collectively this is called chronic kidney disease ‐ mineral bone disorder ( CKD‐MBD ) . Treatment of hyperphosphatemia requires a combination of dietary phosphate restrictions , use of oral phosphate binder therapy to reduce intestinal phosphate absorption , vitamin D3 ( calcitriol ) supplementation and adequate dialysis prescription to promote removal of phosphate.12–15 The treatment goal is to maintain serum phosphate levels at near normal , 0.7 ‐ 1.6mmol/L ( 3.5 ‐ 5.5 mg/dL)16 , and that sustained control of serum phosphate is a strong predictor of improved survival in people receiving HD.11 However approximately 40 % of patients receiving HD have a serum phosphate level of > 1.6mmol/L.16 Dietary phosphate restriction The implementation of dietary phosphate restrictions is the first step in treating hyperphosphatemia . The average daily adult diet contains approximately 800‐1500 mg of phosphate which is absorbed mostly in the duodenum and jejunum.17 However , there is a linear relationship between phosphate and protein intake.1 In general , foods high in phosphate such as milk and meat are rich in protein . For each gram of protein , there is approximately 13‐15 mg of phosphate.17 The recommended protein intake for a HD patient is 0.8 g per kg of body weight per day.7,18 However , the dietary restrictions necessary to sustain acceptable serum phosphate in HD patients could lead to protein malnutrition.4,7,19 Therefore , dietary phosphate restriction is not sufficient to control serum phosphate levels to current national/international guidelines .19 Phosphate binders The mainstay treatment of hyperphosphatemia is the use of oral phosphate binder medication.1,20 Phosphate binders lower phosphate absorption in the intestines by binding to and sequestering phosphate in the gastrointestinal tract , forming insoluble products that are not readily absorbed.21 The Dialysis Outcomes and Practice Patterns Study ( DOPPS ) involving 23,898 patients on HD at 923 facilities in 12 countries found that 88 % of patients were prescribed phosphate binders and 12 % were not . This study found a 25 % lower mortality rate ( HR , 0.75 ; 95 % CI , 0.68‐0.83 ) in patients who were prescribed phosphate binders versus those not prescribed phosphate binder medication.11 However , most people receiving phosphate binding medication do not achieve target serum phosphate level.3 Hemodialysis The basic conventional four‐hour thrice‐weekly HD removes approximately 700‐1,000 mg of phosphate per session , result ing in a weekly reduction of 2100‐3000mg.8,21,22 Effective phosphate removal through HD is complicated by phosphate 's biphasic elimination from the body . Kinetic studies have shown that serum phosphate levels drop rapidly in the first one to two hours of HD treatment and then reach a plateau.8,22 Soon after HD , a rebound of serum phosphate occurs to a rise of about 30‐40 % . This is because of the slow influx of elements to the extracellular space after a st and ard HD session.3,8,22 It has been recognized that increasing dialysis frequency or duration leads to reduced serum phosphate.19 Data from the Frequent Haemodialysis Network nocturnal trial showed that daily or extended nocturnal HD led to an average decrease in serum phosphate levels of 0.4mmol/L ( 95 % CI : 0.3‐0.7mmol/L ) compared with conventional four‐hour thrice‐weekly HD treatment.23 In spite of the relatively low removal rates of phosphorus achieved by HD it is indicative that HD alone can not correct the phosphate levels that are associated with the usual dietary content of phosphate.21,22 Therefore , successful treatment of hyperphosphatemia requires patients adhering to a combination of dietary phosphate restrictions,8 use of oral phosphate binder therapy to reduce intestinal phosphate absorption21 and adequate HD prescription to promote removal of phosphate.24 Adherence to phosphate control Research on adherence to phosphate control date s back to 1960.14 However , the use of education and behavioral interventions to improve long term adherence to phosphate control has been subjected to less investigation in people with ESKD . Several research studies indicate education and behavioral interventions could help individuals change their behavior and hence increase adherence to phosphate control.5,13,20,25,26 A number of studies have used different educational interventions , carried out by either nurses or dieticians . The education sessions were one‐on‐one or group , and verbal or video was used to provide the education.13,14,27,28 Also , structured psychological approaches aim ed at helping patients to change their beliefs , consequently developing healthy behavior , have been used to produce positive results in improving adherence to diet , medication and HD treatment.28–31 These studies illustrate that theoretical and empirically based behavioral approaches are feasible and can result in a positive reduction of serum phosphate level . However , further developments of clinical ly useful behavioral and educational strategies are needed to sustain long term adherence with phosphate control . A literature search of the Cochrane central register of controlled trials , JBI , Prospero international prospect i ve register of systematic review and Campbell collaboration systematic review s was conducted and only one systematic review of relevance to this topic was found . This systematic review was of r and omized controlled trials of educational and counselling interventions to improve dietary phosphate adherence in both HD and pre‐dialysis patients .26 However , this systematic review did not include all treatment methods that are used in combination to control phosphate . The control of serum phosphate levels in people receiving HD continues to be a challenge for practitioners and is of clinical significance to patient outcomes . If left untreated hyperphosphatemia significantly increases the risk of morbidity and mortality in people with ESKD.12 It is important to review studies that have been undertaken comparing the outcomes of education and behavioral interventions , regardless of study design , targeting patient adherence to dietary phosphate intake , phosphate binder medication and HD treatment OBJECTIVE Assess the effect of intensive nutrition education by trained dedicated dietitians on osteodystrophy management among hemodialysis patients . METHODS R and omized controlled trial in 12 hospital-based hemodialysis units equally distributed over clusters 1 and 2 . Cluster 1 patients were either assigned to usual care ( n=96 ) or to individualized intensive staged-based nutrition education by a dedicated renal dietitian ( n=88 ) . Cluster 2 patients ( n=210 ) received nutrition education from general hospital dietitians , educating their patients at their spare time from hospital duties . Main outcomes were : ( 1 ) dietary knowledge(% ) , ( 2 ) behavioral change , ( 3 ) serum phosphorus ( mmol/L ) , each measured at T0 ( baseline ) , T1 ( post 6 month intervention ) and T2 ( post 6 month follow up ) . RESULTS Significant improvement was found only among patients receiving intensive education from a dedicated dietitian at T1 ; the change regressed at T2 without statistical significance : knowledge ( T0 : 40.3 ; T1 : 64 ; T2 : 63 ) and serum phosphorus ( T0 : 1.79 ; T1 : 1.65 ; T2 : 1.70 ) ; behavioral stages changed significantly throughout the study ( T0 : Preparation , T1 : Action , T2 : Preparation ) . CONCLUSION The intensive protocol showed to be the most effective . PRACTICE IMPLICATION S Integrating dedicated dietitians and stage-based education in hemodialysis units may improve the nutritional management of patients in Lebanon and countries with similar health care systems
Background People with end-stage kidney disease ( ESKD ) develop impaired excretion of phosphate .
Hyperphosphatemia develops in ESKD as a result of the kidney 's reduced ability to excrete ingested phosphate load and is characterized by high bone turnover and increased musculoskeletal morbidity including bone pain and muscle weakness .
Increased serum phosphate levels are also associated with cardiovascular disease and associated mortality .
These effects are significant considering that cardiovascular disease is the leading cause of death in ESKD , making phosphate control a crucial treatment goal .
Objectives To determine the effectiveness of education or behavioral interventions on adherence to phosphate control in adults with ESKD receiving hemodialysis ( HD ) .