Adherence to Fluid Intake Recommendations in Kidney Stone Patients

NCT05329389 | Unknown

• 1 other identifier: StoneMD_Schools_for_patients
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 1

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.

Conditions

Urolithiasis

Keywords

application; StoneMD; Schools of patients

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Likert scale questionnaire scores

  12 month

Study Arms (3)

StoneMD

EXPERIMENTAL

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; Behavioral: Standard recommendation

StoneMD & Schools of Patients

EXPERIMENTAL

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; Behavioral: Schools of Patients; Behavioral: Standard recommendation

Recommendations only

ACTIVE COMPARATOR

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

Interventions

StoneMD DEVICE

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

StoneMD; StoneMD & Schools of Patients

Schools of Patients BEHAVIORAL

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

StoneMD & Schools of Patients

Standard recommendation BEHAVIORAL

Only fluid balance recommendations given at the day of discharge.

Recommendations only; StoneMD; StoneMD & Schools of Patients

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Low risk recurrence group patients;
• Patients after the first stone surgery;

You may not qualify if:

• Recurrent cases of stone formation;
• Patients, who do not have smartphones;
• Patients, who can't visit "Schools for Patients" with kidney stone disease;

Sponsors & Collaborators

• Gadzhiev Nariman: lead

Study Sites (1)

SBPSU

Saint Petersburg, 190005, Russia

RECRUITING

Related Publications (5)

• 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.

  PMID: 2688503 BACKGROUND

• 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.

  PMID: 14681713 BACKGROUND

• 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.

  PMID: 25454613 BACKGROUND

• 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.

  PMID: 29713752 BACKGROUND

• 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

  BACKGROUND

MeSH Terms

Conditions

Urolithiasis

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Nariman Gadzhiev, PhD

  Deputy Medical Director

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Vitalii Gelig, MD

CONTACT

+7 905 200-83-68; vgelig@yandex.ru

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: PhD, Urologist, Deputy Medical Director of Saint-Petersburg State University Clinic

Model Details: 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.

Study Record Dates

• First Submitted: March 29, 2022
• First Posted: April 15, 2022
• Study Start: January 1, 2023
• Primary Completion: April 4, 2024
• Study Completion: July 1, 2024
• Last Updated: May 9, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)