Don't get left behind! The modernized is coming. Check it out now.
Say goodbye to!
The new site is coming soon - go to the modernized
Working… Menu

KidneYou - Innovative Digital Therapy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT05286632
Recruitment Status : Recruiting
First Posted : March 18, 2022
Last Update Posted : July 21, 2022
Information provided by (Responsible Party):
Advice Pharma Group srl

Brief 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).

Condition or disease Intervention/treatment Phase
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 Device: KidneYou APP Not Applicable

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 210 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is an interventional, multicentric, randomized, double arm, comparative, parallel, open-label study.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Evaluation of Performance and Safety of App KidneYou, an Innovative Digital Therapy, in Improving Health of Patients With Chronic Kidney Disease (CKD) by Increasing Their Adherence to Dietary, Exercise Regimens or Mindfulness Program
Actual Study Start Date : July 18, 2022
Estimated Primary Completion Date : January 2024
Estimated Study Completion Date : January 2024

Arm Intervention/treatment
Experimental: KidneYou APP

In patients randomized in Group A (intervention group) the NP program will be administered by means of App KidneYou. Each patient will select the assigned daily menu or the proposed alternatives, following instructions reported for breakfast, mid-morning snack, lunch, afternoon snack, and dinner.

Patients randomized to Group A (intervention group) will be administered the PA program by means of App KidneYou. Each patient will follow the assigned exercise program (i.e., recommended type of PA, minutes of exercise/day, number of days/week, level of intensity).

Only patients randomized to Group A (KidneYou users) will be invited by the investigator to follow stress-reducing activities. This difference between the two groups is based on the nature of the mindfulness program, consisting solely of multimedia contents.

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.

No Intervention: Standard of care control group

In patients randomized in Group B (control group) the NP program will be administered by means of a paper diary containing the entire range of daily menu and related alternatives needed to terminate the 3-month study period.

Patients randomized to Group B (control group) will be administered the PA program by means of a paper diary containing the entire range of exercises needed to terminate the 3-month study period.

The stress reduction program is not a "standard of care" currently used within the treatment strategy of CKD patients, neither through face-to-face visits with a specialist, nor through multimedia content.

Patients provided with paper diary and randomized in Group B (KidneYou non-users) represent the population followed by the current "standard of care" and will not be provided with any multimedia content in the context of their participation in the present study.

Primary Outcome Measures :
  1. Evaluation of changes in azoturia [ Time Frame: Daily / Assessment at each month for three months ]
    The percentage of achievement of a mean reduction of at least 10 percent of azoturia (g/24h).

  2. Evaluation of changes in distance covered [ Time Frame: Daily / Assessment at each month for three months ]
    The achievement of a mean increase of at least 15 percent of distance (meters in the 6 Minutes Walking Test - 6MWT).

  3. Evaluation of changes in Perceived Stress [ Time Frame: Daily / Assessment at each month for three months ]
    The achievement of a mean decrease of at least 10 percent of perceived stress (according to the Perceived Stress scale of Cohen) in KidneyYou users exposed to a 3-month Nutritional Program, PA Program and Mindfulness Program compared to KidneyYou non-users and non-exposed to the same 3-month programs.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

- Age

  1. Participant must be ≥18 years of age, at the time of signing the informed consent.

    Type of Participant and Disease Characteristics

  2. Participants with Chronic Kidney Disease (CKD) classified as Glomerular Filtration Rate (GFR) category G3b (30-44 ml/min/1.73 m2) or G4 (15-29 ml/min/1.73 m2); persistent albuminuria category A1 (<30 mg/g [<3 mg/mmol]) or A2 (30-300 mg/g [3-30 mg/mmol]); AND with presence of at least of the following causal etiologies: diabetes, arterial hypertension, chronic glomerulonephritis, cystic kidney diseases (e.g. polycystic kidney, nephronophthisis, cortical or tubular glomerular cysts, cystic diseases of the renal medulla, tuberous sclerosis, etc); AND with both abnormalities of kidney function (i.e., GFR and albuminuria) and structure (causal etiologies) present for >3 months, with implications for health.

    AND with a total score >12 in the Perceived Stress Scale (PSS) questionnaire by Cohen (Appendix E).


  3. Male and Female Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

    Informed Consent

  4. Capable of giving signed informed consent as described in Appendix A which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.

    - Other Criteria

  5. Participants owning a mobile phone, willing to use mobile Apps and this type of technology (technology-savvy) and to download KidneYou.
  6. Native speakers of Italian language or foreign subjects who have a full understanding of the Italian language, as the instructions and information for all health programs (i.e., dietary, physical activity, mindfulness) will only be given in Italian.

Exclusion Criteria:

- Medical Conditions

  1. Any type of acute and/or chronic joint disease that prevents the patient from undergoing the recommended physical activities and interferes with the performance of the 6-MWT.
  2. Any type of acute and/or chronic muscle diseases.
  3. History or current evidence of depression, sleep disturbance, suicidal ideation or any mental (behavioural or psychological illness) disorder.
  4. Patient's refusal or inability to follow dietary rules due to socio-economic or psychological distress.
  5. Chewing disorder.
  6. Lack of motivation to follow NP, PA program, psychological program and/or deterioration in the quality of life.
  7. Positive hepatitis C antibody, hepatitis B virus surface antigen or hepatitis B virus core antibody, Child-Pugh class C (Appendix G), at baseline visit.
  8. Evidence to have tested positive for human immunodeficiency virus (HIV).
  9. History or current evidence of drug or alcohol abuse.
  10. History of QT prolongation and/or congenital long QT syndrome.
  11. History of arrhythmia (multifocal premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia), which is symptomatic or requires treatment (CTCAE Grade 3), symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia. Participants with atrial fibrillation controlled by medication are permitted.
  12. Solid cancer, blood and/or hematopoietic cancer
  13. Autoimmune diseases (i.e. systemic lupus erythematosus, scleroderma, rheumatoid arthritis, etc.).
  14. Addison's disease.
  15. Amyloidosis.

    - Prior/Concomitant Therapy

  16. Any change (e.g., increase/decrease of medication dosage(s), termination of current medication(s), addition of new medication(s), replacement of one or more medication(s)) in the current patient's treatment strategy (concomitant therapies) due to subject's enrolment in this study.

    - Prior/Concurrent Clinical Study Experience

  17. Participation in another clinical study with an Investigational Product administered in the last 6 months.

    - Diagnostic Assessments

  18. Not applicable.

    - Other Exclusions

  19. Involvement in the planning and/or conduct of the study (applies to both Advice Pharma S.r.l. staff and/or staff at the study site).
  20. Judgment by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements.
  21. Previous enrolment or randomisation in the present study.
  22. For women only - currently pregnant (confirmed with positive pregnancy test) or breastfeeding.
  23. As judged by the investigator, any evidence of CKD patient's condition which in the investigator's opinion makes it undesirable for the subject to participate in the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT05286632

Layout table for location contacts
Contact: Alessandro Flavio Ferri 3286656325 ext 0039
Contact: Andrea De Marco 3426635117 ext 0039

Layout table for location information
U.O. Nefrologia Recruiting
Bari, Italy
Contact: Loreto Gesualdo, Prof         
Sponsors and Collaborators
Advice Pharma Group srl
Layout table for investigator information
Study Director: Alessandro Flavio Ferri Advice Pharma Group S.r.l.
Publications of Results:
Piepoli MF, Hoes AW, Agewall S, Albus C, Brotons C, Catapano AL, Cooney MT, Corra U, Cosyns B, Deaton C, Graham I, Hall MS, Hobbs FDR, Lochen ML, Lollgen H, Marques-Vidal P, Perk J, Prescott E, Redon J, Richter DJ, Sattar N, Smulders Y, Tiberi M, van der Worp HB, van Dis I, Verschuren WMM, Binno S; ESC Scientific Document Group. 2016 European Guidelines on cardiovascular disease prevention in clinical practice: The Sixth Joint Task Force of the European Society of Cardiology and Other Societies on Cardiovascular Disease Prevention in Clinical Practice (constituted by representatives of 10 societies and by invited experts)Developed with the special contribution of the European Association for Cardiovascular Prevention & Rehabilitation (EACPR). Eur Heart J. 2016 Aug 1;37(29):2315-2381. doi: 10.1093/eurheartj/ehw106. Epub 2016 May 23. No abstract available.

Layout table for additonal information
Responsible Party: Advice Pharma Group srl Identifier: NCT05286632    
Other Study ID Numbers: ADVICE-001-2022
First Posted: March 18, 2022    Key Record Dates
Last Update Posted: July 21, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Advice Pharma Group srl:
Digital Therapeutics
Digital Medicine
Software Medical Device
Quality of life
Digital Therapy
Additional relevant MeSH terms:
Layout table for MeSH terms
Tuberous Sclerosis
Kidney Diseases
Renal Insufficiency, Chronic
Polycystic Kidney Diseases
Kidney Diseases, Cystic
Pathologic Processes
Urologic Diseases
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Urogenital Diseases
Male Urogenital Diseases
Renal Insufficiency
Chronic Disease
Disease Attributes
Abnormalities, Multiple
Congenital Abnormalities
Genetic Diseases, Inborn
Urination Disorders
Urological Manifestations
Neoplasms, Multiple Primary
Neoplastic Syndromes, Hereditary
Malformations of Cortical Development, Group I
Malformations of Cortical Development