Ignite Creation Date:
2024-05-06 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 2:27 PM
Study NCT ID:
NCT05286632
Status:
RECRUITING
Last Update Posted:
2024-02-08
First Post:
2022-02-25
Brief Title:
KidneYou - Innovative Digital Therapy
Sponsor:
Advice Pharma Group srl
Organization:
Advice Pharma Group srl
Study Overview
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
Status:
RECRUITING
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 patients KidneYou has been set up to improve the commitment of patients in following therapeutic directives ie nutritional programs dailyweekly physical activities to manage their chronic diseases like CKD Moreover KidneYou can improve patients awareness about hisher disease mindfulness so as to increase the individual human ability to be fully present at the ongoing diseases 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 G3bG4 categories A1A2 categories can improve the CKD-related patients health conditions by positive changes in the subjects lifestyle ie healthy eating physical activity participation and by means of cumulative stress reduction ie mindfulness program originating from the underlying chronic disease and from diagnosis and treatment interventions necessary to manage it Some lifestyle programs ie nutrition and physical exercises will be delivered to both randomized groups by different modalities ie withwithout KidneYou while other programs ie 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 patients adherence to clinical advices and consequently patients 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 withwithout 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 patients 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
V0 - Baseline
V1 - 6 weeks after baseline Day 422
V2 - 12 weeks after baseline Day 842 End of lifestyle program administration
V3 - 4 weeks after V2 Day 1124 Follow-up visit and End of Study EOS visit
BenefitRisk Assessment Benefits for patients resulting from study implementation are the simultaneous application of the three non-pharmacological programs for improving the health of CKD patients The expected results are that the simultaneous use of the three programs will allow greater improvements than those achieved so far with the separate use of programs Instead of the experimental evidence published so far the present study intends to measure the objective benefits rather than the perceived ones by CKD patients For this the composite primary objectiveendpoint consists of easily measurable objective markers
Improvements are expected in both treatment groups as food and physical programs will also be implemented in the control KidneYou non-users group However in the investigational group KidneYou users it is assumed to achieve higher benefits thanks to the possibility to offer by means of the App software the third psychological program mindfulness consisting of multimedia contents The higher expected benefits in the investigational group are justified by the greater attractiveness of the App compared to paper diary in the control group with a consequent increase in compliance and effectiveness in KidneYou users
Possible risks that can be anticipated in this specific study population may be related to clinical events emerging from adherence to at least one of the three non-pharmacological programs such as hypoglycemia nausea vomiting gastrointestinal discomfort physical accidents during exercises hypertensive crises obsessive feeling about exercise and food intake anxietyguilt when not reaching assigned exercise or food intake goals interferences with subjects daily activities andor social life neuroses about individual body image or any other adverse experience
Primary Objective
- To improve the quality and quantity of dietary intake in patients using KidneYou compared to patients unprovided with the App after 3 months of customized Nutritional Program NP
OR
- To increase energy expenditure in patients using KidneYou compared to patients unprovided with KidneYou after 3 months of customized Physical Activity Program PA
OR
- To relieve the stress related to the underlying CKD condition in patients using KidneYou compared to patients unprovided with KidneYou after 3 months of study
Secondary Objectves
1 To help patients to achieve two or more of the above-mentioned objectives
2 To describe each primary objective achieved in each randomized group
3 To stratify the primary objective results by G3b and G4 category of CKD classification
4 To stratify the primary objective results by A1 and A2 category of CKD classification
5 To assess the degree of azoturia reduction g24h in each treatment group during the study
6 To assess differences in azoturia reduction g24h between the two randomized groups during the study
7 To assess the degree of physical function improvements in each treatment group during the 6-MWT
8 To assess differences in physical function improvements between the two randomized groups during the study
9 To assess the degree of physical activity increase minutes in each treatment group during the study
10 To assess the degree of stress reduction Perceived Stress Scale PSS of Cohen in each treatment group during the study
11 To assess differences of stress reduction Perceived Stress Scale PSS of Cohen between the two randomized groups during the study
12 To detect the acceptability level in KidneYou users
Safety 13 To describe the safety profile in the two treatment groups
Primary Endpoints
- To evaluate the achievement of a mean reduction of at least 10 of azoturia g24h in Chronic Kidney Disease CKD KidneYou users exposed to a 3-month Nutritional Program NP compared to CKD KidneYou non-users exposed to the same 3-month NP
OR
- To evaluate the achievement of a mean increase of at least 15 of distance meters in the 6-MWT in CKD KidneYou users exposed to a 3-month PA Program compared to CKD KidneYou non-users exposed to the same 3-month PA Program
OR
- To evaluate the achievement of a mean decrease of at least 10 of perceived stress according to the Perceived Stress Scale PSS of Cohen in CKD KidneYou users exposed to a 3-month Mindfulness Program MP compared to CKD KidneYou nonusers and non-exposed to the same MP
Safety Endpoint To assess the rate of adverse events adverse device effects abnormality of laboratory
Statistical Hypotheses This study is designed to test the null hypothesis that the percentage success intended as primary endpoint achievement in KidneYou non-users is equal to the percentage success in KidneYou users The alternative hypothesis is that the percentage success in KidneYou nonusers is different from the percentage success in KidneYou users
Sample Size Determination The sample size is estimated to provide statistical power for the primary endpoint The sample size calculation is based on the combination of expected proportion of success in the control group and expected delta Δ of success in the experimental group
With a significance level α equal to 005 and a power equal to 80 a sample size of 190 subjects 95 per group is required to detect as significant if any a success delta in favor of the experimental group equal to 20 under the hypothesis of success rate of 40 in the control group and success rate of 60 in the experimental group
Data Quality Assurance All participant data relating to the study will be recorded on eCRF unless transmitted to the sponsor or designee electronically eg laboratory data The investigator is responsible for verifying that data entries are accurate and correct by electronically signing the eCRF
The investigator must permit study-related monitoring audits Institutional Review BoardEthic Committee review and regulatory agency inspections and provide direct access to source data documents
The sponsor or designee is responsible for the data management of this study including quality checking of the data
Study monitors will perform ongoing source data verification to confirm that data entered into the eCRF by authorised site personnel are accurate complete and verifiable from source documents that the safety and rights of participants are being protected and that the study is being conducted in accordance with the currently approved protocol and any other study agreements ICH International Conference on Harmonization GCP Good Clinical Practice and all applicable regulatory requirements
The aim of this study is to determine whether the medical device KidneYou randomly assigned to CKD patients G3bG4 categories A1A2 categories can improve the CKD-related patients health conditions by positive changes in the subjects lifestyle ie healthy eating physical activity participation and by means of cumulative stress reduction ie mindfulness program originating from the underlying chronic disease and from diagnosis and treatment interventions necessary to manage it Some lifestyle programs ie nutrition and physical exercises will be delivered to both randomized groups by different modalities ie withwithout KidneYou while other programs ie 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 patients adherence to clinical advices and consequently patients 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 withwithout 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 patients 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
V0 - Baseline
V1 - 6 weeks after baseline Day 422
V2 - 12 weeks after baseline Day 842 End of lifestyle program administration
V3 - 4 weeks after V2 Day 1124 Follow-up visit and End of Study EOS visit
BenefitRisk Assessment Benefits for patients resulting from study implementation are the simultaneous application of the three non-pharmacological programs for improving the health of CKD patients The expected results are that the simultaneous use of the three programs will allow greater improvements than those achieved so far with the separate use of programs Instead of the experimental evidence published so far the present study intends to measure the objective benefits rather than the perceived ones by CKD patients For this the composite primary objectiveendpoint consists of easily measurable objective markers
Improvements are expected in both treatment groups as food and physical programs will also be implemented in the control KidneYou non-users group However in the investigational group KidneYou users it is assumed to achieve higher benefits thanks to the possibility to offer by means of the App software the third psychological program mindfulness consisting of multimedia contents The higher expected benefits in the investigational group are justified by the greater attractiveness of the App compared to paper diary in the control group with a consequent increase in compliance and effectiveness in KidneYou users
Possible risks that can be anticipated in this specific study population may be related to clinical events emerging from adherence to at least one of the three non-pharmacological programs such as hypoglycemia nausea vomiting gastrointestinal discomfort physical accidents during exercises hypertensive crises obsessive feeling about exercise and food intake anxietyguilt when not reaching assigned exercise or food intake goals interferences with subjects daily activities andor social life neuroses about individual body image or any other adverse experience
Primary Objective
- To improve the quality and quantity of dietary intake in patients using KidneYou compared to patients unprovided with the App after 3 months of customized Nutritional Program NP
OR
- To increase energy expenditure in patients using KidneYou compared to patients unprovided with KidneYou after 3 months of customized Physical Activity Program PA
OR
- To relieve the stress related to the underlying CKD condition in patients using KidneYou compared to patients unprovided with KidneYou after 3 months of study
Secondary Objectves
1 To help patients to achieve two or more of the above-mentioned objectives
2 To describe each primary objective achieved in each randomized group
3 To stratify the primary objective results by G3b and G4 category of CKD classification
4 To stratify the primary objective results by A1 and A2 category of CKD classification
5 To assess the degree of azoturia reduction g24h in each treatment group during the study
6 To assess differences in azoturia reduction g24h between the two randomized groups during the study
7 To assess the degree of physical function improvements in each treatment group during the 6-MWT
8 To assess differences in physical function improvements between the two randomized groups during the study
9 To assess the degree of physical activity increase minutes in each treatment group during the study
10 To assess the degree of stress reduction Perceived Stress Scale PSS of Cohen in each treatment group during the study
11 To assess differences of stress reduction Perceived Stress Scale PSS of Cohen between the two randomized groups during the study
12 To detect the acceptability level in KidneYou users
Safety 13 To describe the safety profile in the two treatment groups
Primary Endpoints
- To evaluate the achievement of a mean reduction of at least 10 of azoturia g24h in Chronic Kidney Disease CKD KidneYou users exposed to a 3-month Nutritional Program NP compared to CKD KidneYou non-users exposed to the same 3-month NP
OR
- To evaluate the achievement of a mean increase of at least 15 of distance meters in the 6-MWT in CKD KidneYou users exposed to a 3-month PA Program compared to CKD KidneYou non-users exposed to the same 3-month PA Program
OR
- To evaluate the achievement of a mean decrease of at least 10 of perceived stress according to the Perceived Stress Scale PSS of Cohen in CKD KidneYou users exposed to a 3-month Mindfulness Program MP compared to CKD KidneYou nonusers and non-exposed to the same MP
Safety Endpoint To assess the rate of adverse events adverse device effects abnormality of laboratory
Statistical Hypotheses This study is designed to test the null hypothesis that the percentage success intended as primary endpoint achievement in KidneYou non-users is equal to the percentage success in KidneYou users The alternative hypothesis is that the percentage success in KidneYou nonusers is different from the percentage success in KidneYou users
Sample Size Determination The sample size is estimated to provide statistical power for the primary endpoint The sample size calculation is based on the combination of expected proportion of success in the control group and expected delta Δ of success in the experimental group
With a significance level α equal to 005 and a power equal to 80 a sample size of 190 subjects 95 per group is required to detect as significant if any a success delta in favor of the experimental group equal to 20 under the hypothesis of success rate of 40 in the control group and success rate of 60 in the experimental group
Data Quality Assurance All participant data relating to the study will be recorded on eCRF unless transmitted to the sponsor or designee electronically eg laboratory data The investigator is responsible for verifying that data entries are accurate and correct by electronically signing the eCRF
The investigator must permit study-related monitoring audits Institutional Review BoardEthic Committee review and regulatory agency inspections and provide direct access to source data documents
The sponsor or designee is responsible for the data management of this study including quality checking of the data
Study monitors will perform ongoing source data verification to confirm that data entered into the eCRF by authorised site personnel are accurate complete and verifiable from source documents that the safety and rights of participants are being protected and that the study is being conducted in accordance with the currently approved protocol and any other study agreements ICH International Conference on Harmonization GCP Good Clinical Practice and all applicable regulatory requirements
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None