Adherence to Fluid Intake Recommendations in Kidney Stone Patients

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

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.

Study Overview

• Status: Recruiting
• Conditions: Urolithiasis
• Intervention / Treatment: Device: StoneMD; Behavioral: Standard recommendation; Behavioral: Schools of Patients

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 Type: Interventional
• Enrollment (Anticipated): 135
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Vitalii Gelig, MD; Phone Number: +7 905 200-83-68; Email: vgelig@yandex.ru

Study Locations

• Russian Federation
  • Saint Petersburg, Russian Federation, 190005
    • Recruiting
    • SBPSU
    • Contact: Vitalii Gelig

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: StoneMD; StoneMD - is an app from App Store (for iOS) or Google Play (for Android).; Behavioral: Standard recommendation; Only fluid balance recommendations given at the day of discharge.
Experimental: 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).	Device: StoneMD; StoneMD - is an app from App Store (for iOS) or Google Play (for Android).; Behavioral: Standard recommendation; Only fluid balance recommendations given at the day of discharge.; Behavioral: Schools of Patients; The "Schools for Patients" with Urolithiasis is an online course for patients with urinary stone disease.
Active Comparator: 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	Behavioral: Standard recommendation; Only fluid balance recommendations given at the day of discharge.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Gadzhiev Nariman
• Investigators: Principal Investigator: Nariman Gadzhiev, PhD, Deputy Medical Director

Publications and helpful links

General Publications

• Uribarri J, Oh MS, Carroll HJ. The first kidney stone. Ann Intern Med. 1989 Dec 15;111(12):1006-9. doi: 10.7326/0003-4819-111-12-1006.
• Skolarikos A, Straub M, Knoll T, Sarica K, Seitz C, Petrik A, Turk C. Metabolic evaluation and recurrence prevention for urinary stone patients: EAU guidelines. Eur Urol. 2015 Apr;67(4):750-63. doi: 10.1016/j.eururo.2014.10.029. Epub 2014 Nov 20.
• Siener R, Hesse A. Fluid intake and epidemiology of urolithiasis. Eur J Clin Nutr. 2003 Dec;57 Suppl 2:S47-51. doi: 10.1038/sj.ejcn.1601901.
• Becker B, Gadzhiev N, Popiolek M, Gross AJ, Netsch C. [A mobile app for patients suffering from kidney stones]. Urologe A. 2018 May;57(5):577-582. doi: 10.1007/s00120-018-0652-0. German.
• Gadjiev N.K., Gorelov D.S., Akopyan G.N., Gelig V.A., Ivanov A.O., Petrov S.B., Kryukova N.U., Reva S.A., Ponomareva Yu.A., Al-Shukri A.S., Mischenko A.A., Kogai M.A., Vasiliev V.N., Chernysheva D.Yu., Obidnyak V.M., Makar'in V.A., Pisarev A.V., Zakuckij A.N., Kuzmin I.V., Amdiy R.E., Korneyev I.A., Al-Shukri S.H. "Schools for Patients" with Urolithiasis and Prostatic Diseases. Vestnik Urologii. 2020;8(1):110-120. (In Russ.) https://doi.org/10.21886/2308-6424-2020-8-1-110-120

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Anticipated): April 4, 2024
• Study Completion (Anticipated): July 1, 2024

Study Registration Dates

• First Submitted: March 29, 2022
• First Submitted That Met QC Criteria: April 6, 2022
• First Posted (Actual): April 15, 2022

Study Record Updates

• Last Update Posted (Actual): May 9, 2023
• Last Update Submitted That Met QC Criteria: May 6, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Keywords: application; StoneMD; Schools of patients
• Additional Relevant MeSH Terms: Urologic Diseases; Urolithiasis
• Other Study ID Numbers: StoneMD_Schools_for_patients

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No