Adherence to Fluid Intake Recommendations in Kidney Stone Patients

Gadzhiev Nariman

Status: Enrolling

Conditions: Urolithiasis

Treatments: Device: StoneMD; Behavioral: Standard recommendation; Behavioral: Schools of Patients

Study type: Interventional

Funder types: Other

Identifiers

NCT05329389

StoneMD_Schools_for_patients

Details and patient eligibility

About

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.

Full 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.

Enrollment: 135 estimated patients

Sex: All

Ages: 40 to 60 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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135 participants in 3 patient groups

StoneMD

Experimental group

Description:

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.

Treatment:

Behavioral: Standard recommendation

Device: StoneMD

StoneMD & Schools of Patients

Experimental group

Description:

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).

Treatment:

Behavioral: Schools of Patients

Behavioral: Standard recommendation

Device: StoneMD

Recommendations only

Active Comparator group

Description:

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

Treatment:

Behavioral: Standard recommendation