KidneYou - Innovative Digital Therapy
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|ClinicalTrials.gov Identifier: NCT05286632|
Recruitment Status : Recruiting
First Posted : March 18, 2022
Last Update Posted : July 21, 2022
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|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|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||210 participants|
|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|
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.
- 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).
- 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).
- 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.
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.
|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
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).
Male and Female Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
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.
- 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.
- 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
- 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.
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 ClinicalTrials.gov identifier (NCT number): NCT05286632
|Contact: Alessandro Flavio Ferri||3286656325 ext firstname.lastname@example.org|
|Contact: Andrea De Marco||3426635117 ext email@example.com|
|Contact: Loreto Gesualdo, Prof|
|Study Director:||Alessandro Flavio Ferri||Advice Pharma Group S.r.l.|
|Responsible Party:||Advice Pharma Group srl|
|Other Study ID Numbers:||
|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|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Software Medical Device
Quality of life
Renal Insufficiency, Chronic
Polycystic Kidney Diseases
Kidney Diseases, Cystic
Female Urogenital Diseases
Female Urogenital Diseases and Pregnancy Complications
Male Urogenital Diseases
Genetic Diseases, Inborn
Neoplasms, Multiple Primary
Neoplastic Syndromes, Hereditary
Malformations of Cortical Development, Group I
Malformations of Cortical Development