Patient Compliance for Metabolic Evaluation and Medical Management in Calcium Stone Patients

Nephrolithiasis Clinical Trial

Official title:

How to Improve Patient Compliance for Metabolic Evaluation and Medical & Dietary Prophylaxis in Calcium Stone Patients?

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04169165
• Other study ID #: eCORE-S-19-001
• Status: Not yet recruiting
• Start date: January 2020
• Est. completion date: February 2021

Study information

• Verified date: November 2019
• Source: EULIS Colloborative Research Working Group
• Contact: Mehmet I Gökce, MD
• Phone: +905333669130
• Email: migokce[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

Calcium oxalate stone, the most common type worldwide, has a recurrence rate of around 50% in ten years. Therefore, identifying the underlying pathophysiological aspects via metabolic evaluation and suggestions for medical & dietary prophylaxis in calcium stone patients is of upmost importance.

However, one of the greatest problem with metabolic evaluation and subsequent therapeutic advices is the patient compliance. Therefore, it is important to identify factors related to patient compliance for metabolic evaluation and medical & dietary prophylaxis in calcium stone patients

Description:

Nephrolithiasis is an important health problem that can deteriorate the renal functions in long term and affects the patients' quality of life. One of the major problems about renal stones is the high rate of recurrence. Calcium oxalate stone, the most common type worldwide, has a recurrence rate of around 50% in ten years. Therefore, identifying the underlying pathophysiological aspects via metabolic evaluation and suggestions for medical & dietary prophylaxis in calcium stone patients is of upmost importance.

However, one of the greatest problem with metabolic evaluation and subsequent therapeutic advices is the patient compliance. In the previous studies, even in case of a dedicated stone clinic, the drop out rate for preventive measures were over 37% per year. The patients' non-compliance may be related to a number of factors associated with the stone clinic, demographic characteristics of the patients, past medical history of the patients, and even the recommended tests and the therapeutic advices.

Therefore, it is important to identify factors related to patient compliance for metabolic evaluation and medical & dietary prophylaxis in calcium stone patients

Methods:

Parameters to be recorded

Age Gender Level of education

• of stone episodes

• of surgical intervention Type of surgical intervention History of SWL Concomitant diseases Other medications Type of metabolic evaluation (24 hour urine, spot morning urine, serum etc.) Drug for medical prophylaxis Dosage of medication (bid/tid, etc.) Side effects Dietary recommendations Compliance to metabolic evaluation Compliance to medical treatment

Statistics:

Patients will be grouped based on:

compliance to metabolic evaluation compliance to medical treatment

The parameters listed above will be compared between the groups with univariate analysis (logistic regression).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 500
• Est. completion date: February 2021
• Est. primary completion date: December 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Diagnosis of calcium oxalate kidney stones

• Suggested metabolic evaluation for kidney stone

• Suggested dietary and/or medical treatment for kidney stone

• Accepted participation in the study

Exclusion Criteria:

• Age less than 18

• Mental disorders

Related Conditions & MeSH terms

• Calcium Oxalate Urolithiasis
• Calculi
• Kidney Calculi
• Nephrolithiasis
• Patient Compliance
• Urolithiasis

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
EULIS Colloborative Research Working Group

References & Publications (8)

Bensalah K, Tuncel A, Raman JD, Bagrodia A, Pearle M, Lotan Y. How physician and patient perceptions differ regarding medical management of stone disease. J Urol. 2009 Sep;182(3):998-1004. doi: 10.1016/j.juro.2009.05.025. Epub 2009 Jul 18. — View Citation

Dauw CA, Yi Y, Bierlein MJ, Yan P, Alruwaily AF, Ghani KR, Wolf JS Jr, Hollenbeck BK, Hollingsworth JM. Medication Nonadherence and Effectiveness of Preventive Pharmacological Therapy for Kidney Stones. J Urol. 2016 Mar;195(3):648-52. doi: 10.1016/j.juro. — View Citation

Hess B. Renal stone clinic survey: calcium stone formers' self-declared understanding of and adherence to physician's recommendations. Urolithiasis. 2017 Aug;45(4):363-370. doi: 10.1007/s00240-016-0916-3. Epub 2016 Aug 29. — View Citation

Parks JH, Asplin JR, Coe FL. Patient adherence to long-term medical treatment of kidney stones. J Urol. 2001 Dec;166(6):2057-60. — View Citation

Pietrow P, Auge BK, Weizer AZ, Delvecchio FC, Silverstein AD, Mathias B, Albala DM, Preminger GM. Durability of the medical management of cystinuria. J Urol. 2003 Jan;169(1):68-70. — View Citation

Prezioso D, Strazzullo P, Lotti T, Bianchi G, Borghi L, Caione P, Carini M, Caudarella R, Ferraro M, Gambaro G, Gelosa M, Guttilla A, Illiano E, Martino M, Meschi T, Messa P, Miano R, Napodano G, Nouvenne A, Rendina D, Rocco F, Rosa M, Sanseverino R, Sale — View Citation

Skolarikos A, Straub M, Knoll T, Sarica K, Seitz C, Petrík A, Türk 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

Trinchieri A. Diet and renal stone formation. Minerva Med. 2013 Feb;104(1):41-54. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	patient compliance rate of metabolic evaluation	the rate of the patients undergo metabolic evaluation tests will be determined	30 days
Primary	patient compliance rate of dietary suggestions	the rate of the patients that follow the dietary suggestions will be determined	6 months
Primary	patient compliance rate of drug treatments	the rate of the patients that have the prescribed drugs will be determined	6 months
Secondary	factors associated with non-compliance to metabolic evaluation	the factors that are related to poor patient compliance to metabolic evaluation will be determined in multivariate analysis	3 months
Secondary	factors associated with non-compliance to dietary suggestions	the factors that are related to poor patient compliance to dietary suggestions will be determined in multivariate analysis	3 months
Secondary	factors associated with non-compliance to medications	the factors that are related to poor patient compliance to medications will be determined in multivariate analysis	3 months