Adherence to Fluid Intake Recommendations After Stone Removal in Low Risk Group Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 135
- Locations
- 1
- Primary Endpoint
- Volume of daily urine
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None
Eligibility Criteria
- Ages
- 40 Years to 60 Years (Adult)
- Sex
- All
- Accepts 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;
Arms & Interventions
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.
Intervention: StoneMD (Device)
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.
Intervention: Standard recommendation (Behavioral)
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).
Intervention: StoneMD (Device)
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).
Intervention: Schools of Patients (Behavioral)
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).
Intervention: Standard recommendation (Behavioral)
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
Intervention: Standard recommendation (Behavioral)
Outcomes
Primary Outcomes
Volume of daily urine
Time Frame: 12 month after the surgery
The primary outcome will be measured in the lab in international units of measurement
Concentration of creatinine in daily urine
Time Frame: 12 month after the surgery
The primary outcome will be measured in the lab in international units of measurement
Secondary Outcomes
- Likert scale questionnaire scores(12 month)
Investigators
Gadzhiev Nariman
PhD, Urologist, Deputy Medical Director of Saint-Petersburg State University Clinic
Saint Petersburg State University, Russia