Chronic Kidney Disease (CKD)
Conditions
Brief 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.
Interventions
DEVICEURIKI 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.
Sponsors
Assistance Publique - Hôpitaux de Paris
SKEZI, IKI, DALI
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults aged 18 years or older. * Chronic kidney disease (CKD) stage 4 or 5 with estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73 m². * Followed in a nephrology department within a structured care pathway that includes nutritional assessment. * Clinical indication or need for nutritional assessment as part of routine care. * Willing and able to use the URIKI device for nutritional assessment. * Able to understand French or English, or assisted by a caregiver capable of supporting device use and understanding study procedures. * Agreement to the use of the device and to the collection and transmission of study-related data. * Affiliation with a social security system or beneficiary of such coverage. * Access to a compatible smartphone, a smartphone provided by IKI, or assistance from a caregiver for use of the mobile application
Exclusion criteria
* Pregnant or breastfeeding women. * Severe cognitive impairment preventing understanding of study procedures or use of the application without caregiver assistance. * Major motor or sensory impairments (e.g., blindness, hemiplegia) preventing use of the device without caregiver assistance. * Inability to understand French or English without support from a caregiver or third party. * Refusal of the loaned smartphone or persistent inability to use the provided equipment despite support. * Refusal to participate in the study or withdrawal after receiving study information. * Concurrent participation in another interventional clinical study deemed incompatible with this study, or an ongoing exclusion period related to another study. * Individuals under legal protection (guardianship or curatorship), unless participation is authorized by the legal representative and ethics committee
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Carbon footprint of the care pathway | Up to 12 months | Estimated change in the carbon footprint of the CKD nutritional care pathway before and after URIKI implementation. |
| Renal outcome | Up to 12 months | Change in estimated glomerular filtration rate (eGFR) slope. |
| Biological outcome | Up to 12 months | Change in urinary albumin-to-creatinine ratio (ACR)/proteinuria. |
| Patient satisfaction | Around Day 30 following URIKI use | Patient satisfaction score |
| Patient engagement | Around Day 30 following URIKI use | Therapeutic education program adherence score |
| Patient digital acceptability | Around Day 30 following URIKI use | Digital solution acceptability score |
| Healthcare professional quality of working life | Upon enrollment of the first participant by the healthcare professional and at month 12 (After completion of participant enrollment). | Quality of working life (QWL) score among healthcare professionals, particularly dietitians. |
Countries
France
Contacts
CONTACTYoucef Sekour
PRINCIPAL_INVESTIGATORCorinne Isnard Bagnis
Assistance Publique - Hôpitaux de Paris
Outcome results
None listed