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

Abstract

BackgroundPoor 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.Methods/DesignThis 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.DiscussionThe 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.Trial registrationCurrent Controlled Trials ISRTN31434033

Starting on haemodialysis: A qualitative study to explore the experience and needs of incident patients

“…This study was part of a randomised controlled trial examining a selfmanagement intervention for haemodialysis patients (see Griva et al, 2011).…”

Testing the Feasibility and Usability of a Novel Smartphone-Based Self-Management Support System for Dialysis Patients: A Pilot Study

“…Improving self-management is an effective way to improve QOL for hemodialysis patients [13-15], raising the expectations that tools to help self-management may be effective in improving their QOL.…”

Effect of stage‐based education provided by dedicated dietitians on hyperphosphataemic haemodialysis patients: results from the Nutrition Education for Management of Osteodystrophy randomised controlled trial

“…Opting for this design was informed by a study by Griva et al . among haemodialysis patients, who argued that allocation of participants based on their shift would limit cross‐contamination of information between groups. However, we encountered an opposite effect in our trial.…”