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

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 m/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 m/year [95% confidence interval (CI) -3.00-1.07] and -1.06 ml/min/1.73 m/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.