A bundled phosphate control intervention (4Ds) for adults with end‐stage kidney disease receiving haemodialysis: A cluster randomized controlled trial protocol

Abstract

Australian and New Zealand Clinical Trials Registry Number ACTRN12617000703303.

A bundled phosphate control intervention (4Ds) for adults with end‐stage kidney disease receiving haemodialysis: A cluster randomized controlled trial

“…An assumption of SCT is that low self‐efficacy affects health behaviour, which in turn leads to poorer outcomes (Bandura, 1982). The level of self‐efficacy is directly influenced by four information sources (performance accomplishments, vicarious experience, verbal persuasion, and self‐appraisal) and each of these were incorporated into the intervention (Milazi et al., 2018). Of the four information sources, performance accomplishment was the most influential source of information in this study.…”

“…The level of self-efficacy is directly influenced by four information sources (performance accomplishments, vicarious experience, verbal persuasion, and self-appraisal) and each of these were incorporated into the intervention (Milazi et al, 2018 There was a significant improvement in the level of adherence for diet, drugs and dialysis (missing) by the intervention group compared with the control group. This improvement reflected that if understanding of information and self-efficacy are increased, then people can successfully adhere to complex behavioural changes (Havas et al, 2018).…”

“…To prevent contamination bias, intervention allocation was stratified by HD unit and cluster randomized according to pattern of haemodialysis shifts. The study protocol was prospectively published (Milazi et al., 2018).…”

“…Sample size estimation was informed from a meta‐analysis of serum phosphate as a physiological index of adherence to phosphate control methods (Milazi et al., 2018). To achieve 80% power and Type 1 error rate (two‐tailed) of 5% with an estimated standardized mean difference between groups of 0.5 ( SD 0.39 mmol/L), a sample size of 21 participants per group was required.…”

“…The intervention was delivered by one member of the research team who was an experienced HD nurse. A detailed description of the intervention and intervention resources have been previously published (Milazi et al., 2018).…”