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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Evaluation of changes in azoturia
研究概览
简要总结
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).
详细描述
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 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.
The aim of this study is to determine whether the medical device KidneYou, randomly assigned to CKD patients (G3b/G4 categories; A1/A2 categories), can improve the CKD-related patient's health conditions by positive changes in the subject's lifestyle (i.e., healthy eating, physical activity participation) and by means of cumulative stress reduction (i.e., mindfulness program) originating from the underlying chronic disease and from diagnosis and treatment interventions necessary to manage it. Some lifestyle programs (i.e., nutrition and physical exercises) will be delivered to both randomized groups by different modalities (i.e. with/without KidneYou), while other programs (i.e., mindfulness) will only be accessible to KidneYou users, requiring a technology support for the multimedia content to be self-administered daily by the App. This innovative method avoids a daily face-to-face intervention administered by healthcare professionals for mental health treatments. Broadly speaking, it is expected that KidneYou may improve a patient's adherence to clinical advices and consequently patient's health condition in users compared to non-users. The enrolled subjects will be randomly assigned to one of the two treatment arms according to a parallel-group design. Subjects included in Group A (intervention group) will be provided with KidneYou, while patients in Group B (non-equivalent group) will be used as control. The study will enrol 210 subjects, both genders, aged ≥18 years, to obtain 190 overall valuable subjects (95 each group). The recruitment period will last 12 months.
For each patient the treatment will last 3 consecutive months (12 weeks) during which lifestyle changes will be implemented with/without KidneYou. At the end of this period the lifestyle program will be terminated, followed by a follow-up visit after 1 further month (16 weeks). The follow-up visit will be used to observe the sustained effects on patient's health 30 days after termination of the change lifestyle programs administered to patients with and without KidneYou.
At the beginning of the study, patients will be evaluated for their stress level by means of the Perceived Stress Scale (PSS) by Cohen (Cohen, 1983). Specifically, it will be used the Italian translation of PSS-10, which is a 10-item questionnaire designed to tap how unpredictable, uncontrollable, and overloaded respondents find their lives. To customize the stress measurement to the population age range expected in this study, according to Norm Table for the PSS 10-item inventory, a cut-off of 12 points was chosen. Therefore, all subjects with a score >12 in the PSS questionnaire delivered at the first study visit (V0), will be considered to have a higher stress level above normal and to have one of the major inclusion criteria.
Each subject will undergo 4 (four) visits and will be examined according to the following schedule:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •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.
排除标准
- •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.
结局指标
主要结局
Evaluation of changes in azoturia
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点