A Randomized Controlled Trial Evaluating Digital Health Intervention on Phosphate Control in Patients on Dialysis

BACKGROUND: Hyperphosphataemia is a common metabolic complication of CKD and is associated with poor health outcomes. Dietary intervention is a key strategy in its management; however, it is complicated by the complexity of the diet and limited access to dietitians. This study evaluated whether a digital health intervention delivering dietary advice alongside standard care was effective in reducing serum phosphate. The present analysis reports the trial's primary outcome. METHODS: This six-month multi-center randomized controlled trial recruited patients receiving dialysis across 23 sites in Australia. Both groups received standard care for six months and the intervention group received the TELEKINESIS App for the first three months. The primary outcome was the change in serum phosphate levels between groups at baseline and at three months. RESULTS: One hundred and ninety dialysis patients were recruited with 99 randomized to receive the intervention. There was no significant difference in change of serum phosphate from baseline to three months between groups. Reductions in serum phosphate were observed in both groups at month three (6 % control; 7 % intervention). Only the intervention showed a progressive, sustained decline reaching 9 % reduction at month six. However, this did not reach significance. Exploratory post hoc analyses indicated that women-particularly those aged ≥65 years-experienced the largest reductions (- 0.93 mg/dL, 13 % month three, to -1.36 mg/dL, 20 % month six). CONCLUSIONS: Although the primary analysis did not demonstrate between-group differences in serum phosphate, the intervention produced sustained within-group improvements to month six. Post hoc evaluations suggest some older adults are able to engage with digital interventions in a manner that may have a meaningful clinical impact and highlights the influence of demographic and household roles on uptake. Future work should explore the use of emerging technology such as artificial intelligence to support a more comprehensive consumer-driven CKD management platform.