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Open Access Highly Accessed Study protocol

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

Konstadina Griva13*, Nandakumar Mooppil2, Penny Seet2, Deby Sarojiuy Pala Krishnan2, Hayley James34 and Stanton P Newman34

Author Affiliations

1 Department of Psychology, National University of Singapore, 9 Arts Link AS402/28, Singapore

2 National Kidney Foundation, Kim Keat Road, Singapore

3 Unit of Behavioural Medicine, Riding House Street, University College London, UK

4 Health Services Research Group, City University, College Building Room A224 St John Street, London, UK

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BMC Nephrology 2011, 12:4  doi:10.1186/1471-2369-12-4

Published: 28 January 2011

Abstract

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 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/Design

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.

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 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 registration

Current Controlled Trials ISRTN31434033