Adherence to Fluid Intake Recommendations in Kidney Stone Patients

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

135 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2024-07-01

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.

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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.

Conditions

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Urolithiasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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StoneMD

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.

Group Type EXPERIMENTAL

StoneMD

Intervention Type DEVICE

StoneMD - is an app from App Store (for iOS) or Google Play (for Android).

Standard recommendation

Intervention Type BEHAVIORAL

Only fluid balance recommendations given at the day of discharge.

StoneMD & Schools of Patients

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).

Group Type EXPERIMENTAL

StoneMD

Intervention Type DEVICE

StoneMD - is an app from App Store (for iOS) or Google Play (for Android).

Schools of Patients

Intervention Type BEHAVIORAL

The "Schools for Patients" with Urolithiasis is an online course for patients with urinary stone disease.

Standard recommendation

Intervention Type BEHAVIORAL

Only fluid balance recommendations given at the day of discharge.

Recommendations only

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

Group Type ACTIVE_COMPARATOR

Standard recommendation

Intervention Type BEHAVIORAL

Only fluid balance recommendations given at the day of discharge.

Interventions

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StoneMD

StoneMD - is an app from App Store (for iOS) or Google Play (for Android).

Intervention Type DEVICE

Schools of Patients

The "Schools for Patients" with Urolithiasis is an online course for patients with urinary stone disease.

Intervention Type BEHAVIORAL

Standard recommendation

Only fluid balance recommendations given at the day of discharge.

Intervention Type BEHAVIORAL

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;

Minimum Eligible Age

40 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No