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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 450
- 试验地点
- 2
- 主要终点
- Before-after mean duration of dietitian consultations
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
Before-after mean duration of dietitian consultations
时间窗: 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).
次要结局
- Carbon footprint of the care pathway(Up to 12 months)
- Renal outcome(Up to 12 months)
- Biological outcome(Up to 12 months)
- Patient satisfaction(Around Day 30 following URIKI use)
- Patient engagement(Around Day 30 following URIKI use)
- Patient digital acceptability(Around Day 30 following URIKI use)
- 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).)