TELEnutrition and KIdNey hEalth Study: protocol for a randomised controlled trial comparing the effect of digital health to standard care on serum phoSphate control in patients on dIalysiS (TeleKinesis Study).

INTRODUCTION

Diet and nutrition play a vital role in all stages of chronic kidney disease (CKD) prevention, treatment and management. In particular, dietary interventions are essential to manage hyperphosphataemia, a common metabolic complication in CKD consistently associated with an increased risk of cardiovascular disease and all-cause morbidity and mortality. Unfortunately, dietary management of any kind in this cohort of patients also comes with the added challenge of limited and variable access to renal dietitians, logistical difficulties and multiple medical appointments. Given the complexity of managing diet in patients on dialysis, there is a need for novel interventions that not only help patients navigate daily challenges but could also be integrated into clinical practice to support the work of dietitians. We are testing if the use of digital health (via a new, specifically designed smartphone App) plus standard care compared to standard care alone is a feasible and effective method of delivering nutritional advice to patients with elevated phosphate levels undertaking dialysis.

METHODS AND ANALYSIS

This is a multicentre codesigned randomised controlled trial (RCT) that will recruit individuals aged 18 years or over on maintenance dialysis for a minimum of 3 months who have a serum phosphate level of ≥1.6 mmol/L. Participants will be recruited from 23 different dialysis sites across Australia. They will be block randomised into two groups in a 1:1 ratio that will either be the intervention group (receive the TeleKinesis App for 3 months in addition to standard care) or the control group (standard care alone). The primary outcome of the study is to assess the effect of this intervention on the change in patients' serum phosphate levels. The RCT will assess the effectiveness of the programme by comparing serum phosphate at baseline, 3 months and follow-up at 6 months. A total recruitment target of n=180 participants is expected.

ETHICS AND DISSEMINATION

Ethics approval was received from the Sir Charles Gairdner and Osborne Park Health Care Group Human Research Ethics Committee on 5 December 2022 (reference RGS0000005559). Informed consent will be given by participants once they have read and signed the patient information and consent form. The results are expected to be published in scientific journals and presented at clinical research conferences and to the consumers who have taken part in the trial. This is protocol 1.0 dated 10 November 2024.

TRIAL REGISTRATION NUMBER

ACTRN12621000746831.