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Adherence to Fluid Intake Recommendations in Kidney Stone Patients

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05329389
Enrollment
135
Registered
2022-04-15
Start date
2023-01-01
Completion date
2024-07-01
Last updated
2023-05-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Urolithiasis

Keywords

application, StoneMD, Schools of patients

Brief summary

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

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.

Interventions

DEVICEStoneMD

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

BEHAVIORALSchools of Patients

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

Only fluid balance recommendations given at the day of discharge.

Sponsors

Gadzhiev Nariman
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Intervention 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.

Eligibility

Sex/Gender
ALL
Age
40 Years to 60 Years
Healthy volunteers
No

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;

Design outcomes

Primary

MeasureTime frameDescription
Volume of daily urine12 month after the surgeryThe primary outcome will be measured in the lab in international units of measurement
Concentration of creatinine in daily urine12 month after the surgeryThe primary outcome will be measured in the lab in international units of measurement

Secondary

MeasureTime frameDescription
Likert scale questionnaire scores12 monthLikert scale questionnaire of the usefulness of the app StoneMD and Schools for patients. Higher scores means a better outcome.

Countries

Russia

Contacts

Primary ContactVitalii Gelig, MD
vgelig@yandex.ru+7 905 200-83-68

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026