Accepted for/Published in: JMIR Research Protocols
Date Submitted: Apr 1, 2025
Date Accepted: Nov 5, 2025
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Rationale and design of an Italian multicenter, randomized, open-label, pre-market study to evaluate safety and performance of the innovative KidneYou app, in improving health of patients with chronic kidney disease by enhancing adherence to dietary, exercise and mindfulness programs.
ABSTRACT
Background:
Chronic kidney disease (CKD) is characterized by long-term structural or functional kidney abnormalities, often progressing over decades and potentially leading to kidney failure, treatable only by dialysis or transplantation. Nutritional, physical activity and mindfulness programs can play a key role in conservative CKD management, aiming to slow the progression of symptoms, decrease drug load, reduce stress and delay dialysis. KidneYou integrates nutrition, exercise, and mindfulness programs to improve CKD patients' health by promoting lifestyle changes and stress reduction. As an innovative medical tool, the KidneYou is designed to address an unmet need by providing a non pharmacological approach for better managing CKD, empowering patients to manage their condition more effectively and sustain a healthier lifestyle, which could ultimately lead to improved disease outcomes. KidneYou is an Investigational Medical Device and
Methods:
This is a multicenter, open-label, randomized, parallel-arm trial aimed at evaluating health improvement in CKD patients exposed to a nonpharmacological treatment involving a nutritional (NP), physical activity (PA), and mindfulness (MP) program delivered to the patient by digital or non-digital technologies. The non-pharmacological interventions are conveyed by a digital technology (investigational arm) compared to a standard, paper-based approach (paper diary, control arm), for three months. The primary aim of the study is to evaluate efficacy of KidneYou, defined by a composite endpoint as the achievement of a mean reduction of at least 10% of azoturia (g/24h) or the achievement of a mean increase of at least 15% of distance (meters in the 6-MWT) or the achievement of a mean decrease of at least 10% of perceived stress, in CKD KidneYou app users compared to CKD KidneYou app non-users, after 3-month. Data will be analysed and presented in accordance with international Consolidated Standards of Reporting Trials guidelines.3 The results of this trial will guide further studies on impact of digital devices to help patients with CKD in improving their condition more effectively and sustain a healthier lifestyle, which could ultimately lead to improved disease outcomes.
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