Status:
COMPLETED
KidneYou - Innovative Digital Therapy
Lead Sponsor:
Advice Pharma Group srl
Conditions:
Chronic Kidney Diseases
Diabetes
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Detailed Description
KidneYou is a medical device designed to deliver digital therapy (DT) to patients. The DT, as part of Digital Health, utilizes high quality digital technologies to stimulate lifestyle changes in patie...
Eligibility Criteria
Inclusion
- \- Age
- Participant must be ≥18 years of age, at the time of signing the informed consent.
- Type of Participant and Disease Characteristics
- 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).
- Sex
- 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
- 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
- Participants owning a mobile phone, willing to use mobile Apps and this type of technology (technology-savvy) and to download KidneYou.
- 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
- \- Medical Conditions
- 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.
- Any type of acute and/or chronic muscle diseases.
- History or current evidence of depression, sleep disturbance, suicidal ideation or any mental (behavioural or psychological illness) disorder.
- Patient's refusal or inability to follow dietary rules due to socio-economic or psychological distress.
- Chewing disorder.
- Lack of motivation to follow NP, PA program, psychological program and/or deterioration in the quality of life.
- Positive hepatitis C antibody, hepatitis B virus surface antigen or hepatitis B virus core antibody, Child-Pugh class C (Appendix G), at baseline visit.
- Evidence to have tested positive for human immunodeficiency virus (HIV).
- History or current evidence of drug or alcohol abuse.
- History of QT prolongation and/or congenital long QT syndrome.
- 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.
- Solid cancer, blood and/or hematopoietic cancer
- Autoimmune diseases (i.e. systemic lupus erythematosus, scleroderma, rheumatoid arthritis, etc.).
- Addison's disease.
- Amyloidosis.
- \- Prior/Concomitant Therapy
- 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
- Participation in another clinical study with an Investigational Product administered in the last 6 months.
- \- Diagnostic Assessments
- Not applicable.
- \- Other Exclusions
- 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).
- 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.
- Previous enrolment or randomisation in the present study.
- For women only - currently pregnant (confirmed with positive pregnancy test) or breastfeeding.
- 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.
Key Trial Info
Start Date :
July 18 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 31 2024
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT05286632
Start Date
July 18 2022
End Date
July 31 2024
Last Update
November 6 2024
Active Locations (1)
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1
U.O. Nefrologia
Bari, Bari, Italy