Adherence to Fluid Intake Recommendations in Kidney Stone Patients

Urolithiasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05329389
• Other study ID #: StoneMD_Schools_for_patients
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2023
• Est. completion date: July 1, 2024

Study information

• Verified date: May 2023
• Source: Saint Petersburg State University, Russia
• Contact: Vitalii Gelig, MD
• Phone: +7 905 200-83-68
• Email: vgelig[@]yandex.ru
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 135
• Est. completion date: July 1, 2024
• Est. primary completion date: April 4, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 60 Years

Eligibility

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;

Related Conditions & MeSH terms

• Urolithiasis

Intervention

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

Behavioral:
• Schools of Patients
The "Schools for Patients" with Urolithiasis is an online course for patients with urinary stone disease.
• Standard recommendation
Only fluid balance recommendations given at the day of discharge.

Locations

Country	Name	City	State
Russian Federation	SBPSU	Saint Petersburg

Sponsors (1)

Lead Sponsor	Collaborator
Gadzhiev Nariman

Country where clinical trial is conducted

Russian Federation, 

References & Publications (5)

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Volume of daily urine	The primary outcome will be measured in the lab in international units of measurement	12 month after the surgery
Primary	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	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