The NKF-NUS hemodialysis trial protocol - a randomized controlled trial to determine the effectiveness of a self management intervention for hemodialysis patients

<p>Abstract</p> <p>Background</p> <p>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 populations. The aim of this trial is to evaluate the effectiveness of a recently developed group based self management intervention for hemodialysis patients compared to standard care.</p> <p>Methods/Design</p> <p>This is a multicentre parallel arm block randomized controlled trial (RCT) of a four session group self management intervention for hemodialysis patients delivered by health care professionals compared to standard care. A total of 176 consenting adults maintained on hemodialysis for a minimum of 6 months will be randomized to receive the self management intervention or standard 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.</p> <p>Discussion</p> <p>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 clinically 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 settings who are specifically trained in facilitating self management in renal patients.</p> <p>Trial registration</p> <p>Current Controlled Trials <a href="http://www.controlled-trials.com/ISRTN31434033">ISRTN31434033</a></p

Renal services for people with diabetes in the UK

Diabetic nephropathy is a serious complication of diabetes that can lead to endstage renal failure (ESRF). It is now the most common cause of ESRF in patients accepted onto renal replacement therapy (RRT) programmes in the UK. Rates of diabetic ESRF are more common in ethnic minority populations. The risk of developing diabetic ESRF is higher in Type 1 diabetes but in absolute terms more patients with Type 2 diabetes develop ESRF and are treated. There is still unmet need for RRT amongst patients with diabetes who develop ESRF. The shortage of organ donors, especially amongst ethnic minorities, means that dialysis is the mainstay of treatment in patients with diabetes and ESRF. This is now largely hospital haemodialysis with an increasing proportion being delivered in satellite units. Demand for RRT from patients with diabetes will increase due to demographic change and the increasing prevalence of diabetes, particularly Type 2, in the population. To meet this challenge closer liaison between those primarily caring for patients with diabetes (primary care physicians and diabetologists) and nephrologists is required to ensure effective surveillance of renal function, to increase early referral and to agree protocols of subsequent care. Continued expansion of high-quality RRT is needed that ensures equity of access with particular targeting in areas with large ethnic minority populations. A national priority must be an increase in the kidney transplant rate

Immunosuppressive therapy for kidney transplantation in adults: a systematic review and economic model.

End-stage renal disease is a long-term irreversible decline in kidney function requiring renal replacement therapy: kidney transplantation, haemodialysis or peritoneal dialysis. The preferred option is kidney transplantation, followed by immunosuppressive therapy (induction and maintenance therapy) to reduce the risk of kidney rejection and prolong graft survival.This article is freely available. Click on the 'Additional Link' above to access the full-text