Assessment of Dietary Balance in Home-Dwelling Patients With Stage 4 and 5 Chronic Kidney Disease Using URIKI (IKI), a Connected Urine Test Strip and In Vitro Diagnostic Medical Device

Condition(s) studied

Investigational drug(s) / intervention(s)

URIKI Digital Urinary Monitoring System: URIKI is a digital in vitro diagnostic system designed to support nutritional assessment in patients with stage 4 or 5 chronic kidney disease. The intervention includes connected urine test strips, a portable reader, the My URIKI mobile application, and a secure healthcare professional platform. Participants perform urine measurements at home once daily for 10 consecutive days and enter nutrition- and hydration-related information into the application, including meal information and patient-reported outcomes. Urinary biomarker results and patient-reported data are transmitted to authorized healthcare professionals and used to support nutritional assessment and personalized dietary follow-up. The intervention is delivered in addition to routine nephrology and dietetic care and is evaluated as part of the implementation of URIKI within the chronic kidney disease nutritional care pathway.

Study summary

The goal of this clinical trial is to evaluate whether the integration of URIKI, a connected urine test strip and in vitro diagnostic medical device, can improve the nutritional management of patients with stage 4 or 5 chronic kidney disease (CKD) living at home. The primary purpose is to assess whether URIKI can support dietary monitoring and optimize dietitians' workload through remote collection of urinary and nutrition-related data.

The main question it aims to answer is:

Does the integration of URIKI improve the efficiency of dietitians' work in the nutritional follow-up of patients with stage 4 or 5 chronic kidney disease?

Participants will:

Receive a URIKI kit at home, including a portable reader, urine test strips, and access to the My URIKI mobile application.

Perform one urine measurement per day at home for 10 consecutive days using the URIKI device.

Enter nutrition- and health-related information into the application, including meal photographs or descriptions, hydration information, and responses to brief questionnaires.

Receive remote support for installation and use of the device if needed. Have their urinary measurements reviewed by authorized healthcare professionals.

Receive a personalized dietary assessment and nutritional feedback from the hospital medical team and/or IKI dietitians through the My URIKI application.

Complete patient experience questionnaires at study entry and at the end of participation.

The expected duration of participation is up to 30 days. Approximately 450 patients with stage 4 or 5 chronic kidney disease will be enrolled in nephrology centers across France.

Eligibility

Primary outcome measure(s)

• Before-after mean duration of dietitian consultations — Outcome compared between the 6-month pre-implementation and 6-month post-implementation periods of URIKI system
  Difference in the mean duration of dietitian consultations dedicated to nutritional assessment per patient, comparing the pre-intervention period (conventional care) and the post-intervention period (care integrating URIKI).

Trial sites (2)

More Assistance Publique - Hôpitaux de Paris trials in France

Other trials for the same condition