KidneYou - Innovative Digital Therapy

Summary

The aim of the study is to assess the improvement of health in patients affected by CKD when they are exposed to non-pharmacological treatment strategies as nutritional program (NP), physical activity program (PA) and mindfulness program (MP), when they are conveyed to the patient by means of digital technologies or not. In the present study, non-pharmacological interventions conveyed by a digital technology (investigational arm) will be compared to a standard, paper-based approach (control arm).

Conditions

• Chronic Kidney Diseases
• Diabetes
• Arterial Hypertension
• Chronic Glomerulonephritis
• Cystic Kidney Diseases
• Polycystic Kidney
• Nephronophthisis
• Cortical Cystic Disease
• Cystic Diseases
• Tuberous Sclerosis
• Albuminuria
• Treatment Adherence
• Treatment Adherence and Compliance

Interventions

DEVICE

KidneYou APP

KidneYou is a medical device designed to deliver digital therapy (DT) to patients. The DT utilizes high quality digital technologies to stimulate lifestyle changes in patients. KidneYou has been set up to improve the commitment of patients in following therapeutic directives (i.e. nutritional programs, daily/weekly physical activities) to manage their chronic diseases like CKD. Moreover, KidneYou can improve patient's awareness about his/her disease (mindfulness) so as to increase the individual human ability to be fully present at the ongoing disease's condition and react to it in active and positive manner. Particularly, the mindfulness program contained in this App has been designed to increase the patient's psychological and mental health, aiming at decreasing the perceived stress due to the underlying disease and to the attempts of life-style changes (i.e., healthy diet and physical activity) which may initially negatively affect the subject's natural attitudes.

Sponsors & Collaborators

• Advice Pharma Group srl

  lead INDUSTRY

Principal Investigators

• Alessandro Flavio Ferri · Advice Pharma Group S.r.l.

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-07-18

Primary Completion

2024-06-28

Completion

2024-07-31

Countries

• Italy

Study Locations