KidneYou - Innovative Digital Therapy

NCT05286632 | Completed

• 1 other identifier: ADVICE-001-2022
• Study Type: interventional
• Target: 210
• Locations: 1 country
• Sites: 1

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).

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

Keywords

Digital Therapeutics; Digital Medicine; Adherence; Software; Software Medical Device; Quality of life; Digital Therapy

Outcome Measures

Primary Outcomes (3)

• Evaluation of changes in azoturia

  The percentage of achievement of a mean reduction of at least 10 percent of azoturia (g/24h).

  Daily / Assessment at each month for three months

• Evaluation of changes in distance covered

  The achievement of a mean increase of at least 15 percent of distance (meters in the 6 Minutes Walking Test - 6MWT).

  Daily / Assessment at each month for three months

• Evaluation of changes in Perceived Stress

  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.

  Daily / Assessment at each month for three months

Study Arms (2)

KidneYou APP

EXPERIMENTAL

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

Standard of care control group

NO INTERVENTION

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.

Interventions

KidneYou APP DEVICE

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.

KidneYou APP

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- 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.

You may not qualify if:

• \- 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.

Sponsors & Collaborators

• Advice Pharma Group srl: lead

Study Sites (1)

U.O. Nefrologia

Bari, Bari, Italy

Location

Related Publications (7)

• Stevens PE, Levin A; Kidney Disease: Improving Global Outcomes Chronic Kidney Disease Guideline Development Work Group Members. Evaluation and management of chronic kidney disease: synopsis of the kidney disease: improving global outcomes 2012 clinical practice guideline. Ann Intern Med. 2013 Jun 4;158(11):825-30. doi: 10.7326/0003-4819-158-11-201306040-00007.

  PMID: 23732715 BACKGROUND

• Cupisti A, Brunori G, Di Iorio BR, D'Alessandro C, Pasticci F, Cosola C, Bellizzi V, Bolasco P, Capitanini A, Fantuzzi AL, Gennari A, Piccoli GB, Quintaliani G, Salomone M, Sandrini M, Santoro D, Babini P, Fiaccadori E, Gambaro G, Garibotto G, Gregorini M, Mandreoli M, Minutolo R, Cancarini G, Conte G, Locatelli F, Gesualdo L. Nutritional treatment of advanced CKD: twenty consensus statements. J Nephrol. 2018 Aug;31(4):457-473. doi: 10.1007/s40620-018-0497-z. Epub 2018 May 24.

  PMID: 29797247 BACKGROUND

• Cohen S, Kamarck T, Mermelstein R. A global measure of perceived stress. J Health Soc Behav. 1983 Dec;24(4):385-96. No abstract available.

  PMID: 6668417 BACKGROUND

• Johansen KL, Painter P. Exercise in individuals with CKD. Am J Kidney Dis. 2012 Jan;59(1):126-34. doi: 10.1053/j.ajkd.2011.10.008. Epub 2011 Nov 23.

  PMID: 22113127 BACKGROUND

• Kang YS, Choi SY, Ryu E. The effectiveness of a stress coping program based on mindfulness meditation on the stress, anxiety, and depression experienced by nursing students in Korea. Nurse Educ Today. 2009 Jul;29(5):538-43. doi: 10.1016/j.nedt.2008.12.003. Epub 2009 Jan 13.

  PMID: 19141364 BACKGROUND

• Huberty J, Green J, Glissmann C, Larkey L, Puzia M, Lee C. Efficacy of the Mindfulness Meditation Mobile App "Calm" to Reduce Stress Among College Students: Randomized Controlled Trial. JMIR Mhealth Uhealth. 2019 Jun 25;7(6):e14273. doi: 10.2196/14273.

  PMID: 31237569 BACKGROUND

• 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.

  PMID: 27222591 BACKGROUND

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Diabetes Mellitus; Hypertension; Kidney Diseases, Cystic; Polycystic Kidney Diseases; Nephronophthisis, familial juvenile; Tuberous Sclerosis; Albuminuria; Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Ciliopathies; Genetic Diseases, Inborn; Hamartoma; Neoplasms; Neoplasms, Multiple Primary; Neoplastic Syndromes, Hereditary; Malformations of Cortical Development, Group I; Malformations of Cortical Development; Nervous System Malformations; Nervous System Diseases; Neurocutaneous Syndromes; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Proteinuria; Urination Disorders; Urological Manifestations; Signs and Symptoms; Health Behavior; Behavior

Study Officials

• Alessandro Flavio Ferri

  Advice Pharma Group S.r.l.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: This is an interventional, multicentric, randomized, double arm, comparative, parallel, open-label study.

Study Record Dates

• First Submitted: February 25, 2022
• First Posted: March 18, 2022
• Study Start: July 18, 2022
• Primary Completion: June 28, 2024
• Study Completion: July 31, 2024
• Last Updated: November 6, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)