Journal Article

Remote symptom monitoring with patient-reported outcome measures in outpatients with chronic kidney disease (PROKID): a multicentre randomised controlled non-inferiority study

Hjollund, Niels Henrik, De Thurah, Annette, Schougaard, Liv Marit Valen, Grove, Birgith Engelst, Randers, Else, Ivarsen, Per, Mose, Frank

2024

Overview

Background The increasing incidence of chronic kidney disease (CKD) is straining the capacity of outpatient clinics. Remote healthcare delivery might improve CKD follow-up compared with conventional face-to-face follow-up. Patient-reported outcomes (PROs) are used to empower remote follow-up and patient engagement. The consequences of shifting from face-to-face follow-up to remote outpatient follow-up on kidney function, health resource utilisation and quality of life remain unknown. Methods We conducted a multicentre pragmatic non-inferiority trial at three outpatient clinics in the Central Denmark Region. A total of 152 incident outpatients with CKD were randomised (1:1:1) to either PRO-based, PRO-telephone follow-up or standard of care (SoC). The primary outcome was the annual change in kidney function measured by the slope of the estimated glomerular filtration rate (eGFR). The non-inferiority margin was an eGFR of 2.85 ml/min/1.73 m2/year. Mean differences were estimated using intention-to-treat (ITT), per protocol and random coefficient models. Results Mean eGFR slope differences between PRO-based and SoC were −0.97 ml/min/1.73 m2/year [95% confidence interval (CI) −3.00–1.07] and −1.06 ml/min/1.73 m2/year (95% CI −3.02–0.89) between PRO-telephone and SoC. Non-inferiority was only established in the per-protocol analysis due to CIs exceeding the margin in the ITT group. Both intervention groups had fewer outpatient visits: −4.95 (95% CI −5.82 to −4.08) for the PRO-based group and −5.21 (95% CI −5.95 to −4.46) for the PRO-telephone group. We found no significant differences in quality of life, illness perception or satisfaction. Conclusion Differences in the eGFR slope between groups were non-significant and results on non-inferiority were inconclusive. Thus, transitioning to remote PRO-based follow-up requires close monitoring of kidney function. Reducing patients’ attendance in the outpatient clinic was possible without decreasing either quality of life or illness perception. ClinicalTrials.gov identifier: NCT03847766 Graphical Abstract Graphical Abstract

• Publisher: Oxford University Press
• Subject: Kidney diseases / Outpatient care facilities / Quality of life