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Adherence to Fluid Intake Recommendations in Kidney Stone Patients

Primary Purpose

Urolithiasis

Status
Recruiting
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
StoneMD
Schools of Patients
Standard recommendation
Sponsored by
Gadzhiev Nariman
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Urolithiasis focused on measuring application, StoneMD, Schools of patients

Eligibility Criteria

40 Years - 60 Years (Adult)All SexesDoes not accept 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;

Sites / Locations

  • SBPSURecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

StoneMD

StoneMD & Schools of Patients

Recommendations only

Arm 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.

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).

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

Outcomes

Primary Outcome Measures

Volume of daily urine
The primary outcome will be measured in the lab in international units of measurement
Concentration of creatinine in daily urine
The primary outcome will be measured in the lab in international units of measurement

Secondary Outcome Measures

Likert scale questionnaire scores
Likert scale questionnaire of the usefulness of the app "StoneMD" and "Schools for patients". Higher scores means a better outcome.

Full Information

First Posted
March 29, 2022
Last Updated
May 6, 2023
Sponsor
Gadzhiev Nariman
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1. Study Identification

Unique Protocol Identification Number
NCT05329389
Brief Title
Adherence to Fluid Intake Recommendations in Kidney Stone Patients
Official Title
Adherence to Fluid Intake Recommendations After Stone Removal in Low Risk Group Patients
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
April 4, 2024 (Anticipated)
Study Completion Date
July 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Gadzhiev Nariman

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Urolithiasis
Keywords
application, StoneMD, Schools of patients

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
135 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
StoneMD
Arm Type
Experimental
Arm 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.
Arm Title
StoneMD & Schools of Patients
Arm Type
Experimental
Arm 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).
Arm Title
Recommendations only
Arm Type
Active Comparator
Arm 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
Intervention Type
Device
Intervention Name(s)
StoneMD
Intervention Description
StoneMD - is an app from App Store (for iOS) or Google Play (for Android).
Intervention Type
Behavioral
Intervention Name(s)
Schools of Patients
Intervention Description
The "Schools for Patients" with Urolithiasis is an online course for patients with urinary stone disease.
Intervention Type
Behavioral
Intervention Name(s)
Standard recommendation
Intervention Description
Only fluid balance recommendations given at the day of discharge.
Primary Outcome Measure Information:
Title
Volume of daily urine
Description
The primary outcome will be measured in the lab in international units of measurement
Time Frame
12 month after the surgery
Title
Concentration of creatinine in daily urine
Description
The primary outcome will be measured in the lab in international units of measurement
Time Frame
12 month after the surgery
Secondary Outcome Measure Information:
Title
Likert scale questionnaire scores
Description
Likert scale questionnaire of the usefulness of the app "StoneMD" and "Schools for patients". Higher scores means a better outcome.
Time Frame
12 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vitalii Gelig, MD
Phone
+7 905 200-83-68
Email
vgelig@yandex.ru
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nariman Gadzhiev, PhD
Organizational Affiliation
Deputy Medical Director
Official's Role
Principal Investigator
Facility Information:
Facility Name
SBPSU
City
Saint Petersburg
ZIP/Postal Code
190005
Country
Russian Federation
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vitalii Gelig

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
2688503
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.
Results Reference
background
PubMed Identifier
14681713
Citation
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.
Results Reference
background
PubMed Identifier
25454613
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.
Results Reference
background
PubMed Identifier
29713752
Citation
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.
Results Reference
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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
Results Reference
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Adherence to Fluid Intake Recommendations in Kidney Stone Patients

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