Clinical trial NCT04169165: Patient Compliance for Metabolic Evaluation and Medical Management in Calcium Stone Patients
Official title: How to Improve Patient Compliance for Metabolic Evaluation and Medical & Dietary Prophylaxis in Calcium Stone Patients?
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Kidney Calculi
Nephrolithiasis
Patient Compliance
Calcium Oxalate Urolithiasis
Keywords: kidney stone
calcium oxalate stone
patient compliance
nephrolithiasis
Lead sponsor: EULIS Colloborative Research Working Group
Sponsor class: NETWORK
First posted: 2019-11-19
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All adult patients diagnosed with a calcium oxalate kidney stones and suggested for metabolic evaluation and dietary and/or medical management will be enrolled in the study.

Brief 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

Detailed 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).

Eligibility criteria: 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

Primary outcomes:
measure: patient compliance rate of metabolic evaluation
timeFrame: 30 days
measure: patient compliance rate of dietary suggestions
timeFrame: 6 months
measure: patient compliance rate of drug treatments
timeFrame: 6 months
Secondary outcomes:
measure: factors associated with non-compliance to metabolic evaluation
timeFrame: 3 months
measure: factors associated with non-compliance to dietary suggestions
timeFrame: 3 months
measure: factors associated with non-compliance to medications
timeFrame: 3 months
Other outcomes:
Locations:
Study officials:
References:
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.
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, Salerno A, Spatafora S, Tasca A, Ticinesi A, Travaglini F, Trinchieri A, Vespasiani G, Zattoni F; CLU Working Group. Dietary treatment of urinary risk factors for renal stone formation. A review of CLU Working Group. Arch Ital Urol Androl. 2015 Jul 7;87(2):105-20. doi: 10.4081/aiua.2015.2.105.
citation: Trinchieri A. Diet and renal stone formation. Minerva Med. 2013 Feb;104(1):41-54.
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.
citation: 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.
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.
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.2015.10.082. Epub 2015 Oct 17.
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. doi: 10.1016/S0022-5347(05)64037-2.