Adherence to Fluid Intake Recommendations in Kidney Stone Patients

Study Overview
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Brief Summary
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The cumulative risk of stone recurrence rate is up to 14% at 1 year, 35% at 5 years, and 52% at 10 years. Low urine volume caused by insufficient fluid consumption is one of the most crucial risk factors for kidney stone formation. According to the guidelines, a copious fluid intake to maintain a urine volume of at least 2.0 to 2.5 L/24 h is recommended for most kidney stone formers. Patients often find it difficult to follow the recommendations in fluid intake, which leads to stone recurrence. Therefore, there is a need to improve patient compliance and adherence to following the instructions on keeping water balance. For this purpose we developed a mixed educational program including two parts. The first is the mobile application called StoneMD: Kidney Stones. The second is the School for Patients with kidney stones, which is responsible for the stone clinic effect.

Detailed Description
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The aim of the study is to test the hypothesis that using mixed educational program additionally to standard recommendations in patients after the first stone surgery episode helps to achieve better adherence to daily fluid intake recommendations than the using standard recommendations alone given at the day of discharge.

Official Title
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Adherence to Fluid Intake Recommendations After Stone Removal in Low Risk Group Patients

Conditions
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Urolithiasis

Intervention / Treatment
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* Device: StoneMD
* Behavioral: Schools of Patients
* Behavioral: Standard recommendation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Low risk recurrence group patients; Patients after the first stone surgery; Exclusion Criteria: Recurrent cases of stone formation; Patients, who do not have smartphones; Patients, who can't visit Schools for Patients with kidney stone disease;

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: In case of presence/absence of inclusion/exclusion criteria and written informed consent will be obtained, patients will be randomized in a 1:1:1 ratio according to the list of randomized blocks using a computer generator. Patients will be randomized at the last available moment in order to minimize bias.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: StoneMD<br>Patients will receive standard recommendations of keeping diuresis at the level of 2.5 l/day and to use the StoneMD application on their smartphones after the surgery. Patients will use the section Water balance and follow the instructions during the 12 month after the surgery. | Device: StoneMD<br>* StoneMD - is an app from App Store (for iOS) or Google Play (for Android).<br>Behavioral: Standard recommendation<br>* Only fluid balance recommendations given at the day of discharge.<br>|
| Experimental: StoneMD & Schools of Patients<br>Patients will receive standard recommendations of keeping diuresis at the level of 2.5 l/day and and recommendations to use the StoneMD application on their smartphones after the surgery. Patients will use the section Water balance and follow the instructions during the 12 month after the surgery. Additionally, patients will visit schools during a following year. Patients receive 4 consultations (one per 3 month). | Device: StoneMD<br>* StoneMD - is an app from App Store (for iOS) or Google Play (for Android).<br>Behavioral: Schools of Patients<br>* The Schools for Patients with Urolithiasis is an online course for patients with urinary stone disease.<br>Behavioral: Standard recommendation<br>* Only fluid balance recommendations given at the day of discharge.<br>|
| Active Comparator: Recommendations only<br>Only fluid balance recommendations given at the day of discharge. Patients will receive recommendations of keeping diuresis at the level of 2.5 l/day after the surgery | Behavioral: Standard recommendation<br>* Only fluid balance recommendations given at the day of discharge.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volume of daily urine | The primary outcome will be measured in the lab in international units of measurement | 12 month after the surgery | 
| Concentration of creatinine in daily urine | The primary outcome will be measured in the lab in international units of measurement | 12 month after the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Likert scale questionnaire scores | Likert scale questionnaire of the usefulness of the app StoneMD and Schools for patients. Higher scores means a better outcome. | 12 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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application, StoneMD, Schools of patients